FrailtyCUIDAFRAILNCT07182747
Feasibility of a Multidisciplinary Student-Led Program to Improve Frailty in Nursing Home Residents
A study testing Nursing students' intervention programme in people with Frailty, run by Universidad de Almeria at 1 site in Spain.
Trial summary
BACKGROUND Frailty, regarded as a potentially reversible process and defined as a progressive deterioration of physiological systems and intrinsic capacity, constitutes a key risk factor for disability, dependency and institutionalisation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Nursing students' intervention programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years.
- Living in one of the institutions participating in the study.
- Signing the informed consent to participate in the study.
Who cannot join
- Requiring palliative care
- Having moderate or severe cognitive impairment (Pfeiffer Test >4); hypotension (systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg), anemia (hemoglobin level <9 g/dL), any acute metabolic disorder, uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg), uncontrolled arrhythmia, stable/unstable angina, uncontrolled chronic or metabolic disease, and advanced cerebrovascular or peripheral vascular disease
- Having undergone surgery within the last six weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Multidisciplinary Intervention Programme Carried Out by Nursing and Physical Activity and Sports Sciences Students to Improve Frailty and Other Related Variables in Older Adults Living in Nursing Homes.
BACKGROUND Frailty, regarded as a potentially reversible process and defined as a progressive deterioration of physiological systems and intrinsic capacity, constitutes a key risk factor for disability, dependency and institutionalisation.
Currently, it is estimated that between 50% and 75% of older adults living in residential care facilities present with frailty. This clinical profile is often directly associated with multiple comorbidities (around 65-85% of this population suffer from several chronic conditions), emotional decline, polypharmacy, malnutrition and a high prevalence of functional and cognitive impairment. Consequently, two out of every three older adults will require long-term care in specialised centres during their lifetime. In this context, nursing homes represent a key setting not only for providing care, but also for the prevention, detection and management of conditions such as frailty. However, care in residential facilities continues to focus on addressing established problems, with low participation in activities with potential benefits and a high perception of loneliness. Therefore, interventions in these contexts aimed at improving frailty are both necessary and urgent, particularly those that integrate a biopsychosocial approach, promote autonomy and foster active ageing.
Read more
Several studies have demonstrated that multidisciplinary intervention programmes and multicomponent physical training are effective in preventing frailty and its consequences. Nevertheless, their widespread implementation is limited by several factors. On the one hand, there is a lack of scientific evidence on the cost-effectiveness of such interventions, and on the other, healthcare systems face budgetary constraints in a context of increasing demand for geriatric care. In the search for more effective interventions to improve frailty and other related variables in older adults residing in nursing homes, supervised multidisciplinary programmes, delivered by health sciences students and implemented by nursing students, may represent a viable alternative. In this regard, students of Physical Activity and Sport Sciences (CAFYD) possess the knowledge required to design physical activity plans adapted to the capacities and needs of older adults. However, given the nature of their care role, nurses provide added value: their continuous presence in the clinical setting enables them to establish a closer therapeutic bond with the patient, ensure thorough monitoring of their progress, and facilitate coordination between physicians and other healthcare team members. These features make nurses key agents in the implementation of comprehensive, person-centred interventions.
Despite the potential of implementing a multidisciplinary intervention programme through health sciences students to improve frailty in older adults living in residential facilities, to the best of our knowledge, no similar interventions exist. Therefore, it is necessary to assess the feasibility of implementing such a proposal prior to conducting a randomised controlled trial to confirm its clinical effectiveness, as this approach plays an important role in determining the most appropriate trial design. To this end, different feasibility study guidelines recommend including variables such as acceptance, adherence and dropout rates as key markers for successful implementation.
STUDY'S HYPOTHESIS The main hypothesis of the CUIDAFRAIL project is that a supervised multidisciplinary intervention programme carried out by nursing and Physical Activity and Sport Sciences students is feasible for improving frailty and other related variables in older adults living in residential care facilities.
AIM AND OBJECTIVES The aim of the CUIDAFRAIL project is to examine the short- term and medium-term effects of a nursing students' multidisciplinary intervention programme on frailty among older adults living in nursing homes.
The secondary objectives of this project are the following:
- To examine the effects of the intervention on frailty, as well as other frailty-related variables, including physical fitness, functionality, fear of falling, emotional status, loneliness, social support and quality of life in older adults living in residential care facilities.
- To examine the effects on physiological and clinical parameters associated with frailty.
- To explore the perceptions and experiences of older adults participating in the programme upon completion.
- To explore the perceptions and experiences of nursing and Physical Activity and Sport Sciences students upon completion of the programme.
STUDY DESIGN A feasibility study will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).
- Conditions
- Frailty
- Being tested
- Nursing students' intervention programme, Standard care from Public Andalusian Health Service
- Keywords
- Frailty, older adults, intervention programme, Physical Activity, Activities of Daily Living, Nursing student, feasibility
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing students' intervention programmeBehavioural
12-week intervention programme conducted by nursing students and students trained in Sciences of Physical Activity and Sport (CAFYD). Participants will receive weekly three sessions of 45-60 minutes. It will include physical exercise and occupational therapy sessions aimed at improving frailty and other related outcomes in the participating older adults through interdisciplinary collaboration and ongoing monitoring. Nursing students will implement personalised intervention programmes designed by a multidisciplinary team comprising CAFYD students, an occupational therapist, and nurses experienced in the care of older adults.
Standard care from Public Andalusian Health ServiceBehavioural
They will receive the standard care provided by the Andalusian Health Service as part of its portfolio of services offered to older adults residing in institutions, as well as the standard care provided by the institutions in which they live. As part of these services, older adults receive support such as accommodation, laundry, health promotion activities, health monitoring, assistance with activities of daily living, individual, group, and community social care, as well as means of communication with the outside world. The action plans or protocols established in care processes for older adults living in nursing homes do not include externally delivered multidisciplinary intervention programmes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants allocated to the 'intervention group' arm will receive the usual care offered by the Public Andalusian Healthcare Service in conjunction with a 12-week nursing students' intervention programme. Receives: Behavioral: Nursing students' intervention programme; Behavioral: Standard care from Public Andalusian Health Service |
| Control group | Active comparator | Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks. Receives: Behavioral: Standard care from Public Andalusian Health Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption
The proportion of older adults who agree to participate out of the total number of older adults offered the programme. This information will be obtained from the records of eligible individuals and those ultimately included.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Adherence
Adherence: The proportion of participants who complete at least 8 of the 12 weeks comprising the entire programme.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Dropout
The proportion of participants who withdraw from the intervention out of the total number of individuals who agreed to participate and began the programme.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Perceived quality of the intervention
Assessed using the Net Promoter Scale (NPS), a tool used to measure user satisfaction with an intervention through the question: "How likely are you to recommend this to someone in a similar situation?" Scores range from 0 to 10, with scores below 5 indicating dissatisfaction and scores above 5 indicating satisfaction.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Frailty
Clinical Frailty Scale (CFS). The CFS is a clinician-administered scale comprising nine levels that classify patients' degree of frailty. Each level describes a set of characteristics related to physical condition, functionality, and cognitive status, ranging from 1 (very fit) to 9 (terminally ill). Scores are assigned based on the patient's overall functioning in daily life, including mobility, dependence for basic and instrumental activities of daily living, presence of chronic diseases, and cognitive impairment. The scale has been validated in residential settings and can also be used in individuals with cognitive impairment, as it does not require self-reporting. Higher scores indicate greater frailty.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Secondary outcomes (29)
Physical condition (SPPB total score)
This will be evaluated using the Short Physical Performance Battery (SPPB). The SPPB assesses the ability to maintain balance for 10 seconds in different positions, the time required to walk 4 metres, and the time required to rise from a chair five times. Each test is scored from 0 to 4, where 4 indicates the highest performance and 0 indicates an inability to complete the test. The total battery score ranges from 0 (worst performance) to 12 (best performance).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Physical condition (Timed Up and Go test)
Additionally, the Timed Up and Go (TUG) test will be used due to its association with fall risk. This test measures the time a participant takes to rise from a chair, walk 3 metres at their usual pace in a straight line, and return to a seated position. Shorter TUG times are considered indicative of better performance. A time exceeding 12 seconds is considered high fall risk; 10-12 seconds indicates moderate risk; and times below 10 seconds generally reflect good mobility and low fall risk.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Leg strength
Leg strength will be assessed using the modified thirty-second chair stand test (m-30s-CST). Participants will be asked to sit in a chair with armrests of identical dimensions for all participants. They will attempt to rise from the chair to a full standing position as many times as possible within 30 seconds. Completing 10 or more repetitions indicates good leg strength and high mobility; 8-9 repetitions correspond to moderate strength and mobility; fewer than 8 repetitions indicate low leg strength and may be associated with increased fall risk.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Grip strength
Grip strength will be evaluated given its documented correlation with frailty. It will be measured using a digital hand dynamometer (TAKEI TKK-5401) unilaterally, distinguishing between dominant and non-dominant hand.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fall risk
The Downton Fall Risk Index will be used. This instrument comprises five sections assessing: previous falls, medication (particularly psychotropic drugs), sensory deficits, mental status, and gait. Each item has a specific score, and the total sum provides an estimate of overall fall risk. Each item can be scored 0 or 1, with a total score of 3 or more indicating a high risk of falls.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Functionality
This will be measured using the Measure of Functional Independence (MIF). The scale includes 18 items, 13 of which are related to physical activities divided into four categories: self-care, continence, transfers, and mobility. The remaining five items assess cognitive and social aspects, divided into communication and social cognition categories. Total scores range from 18 to 126, with higher scores indicating greater independence. The psychometric properties of the MIF are adequate.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fear of falling
This will be assessed using the Short Falls Efficacy Scale-International (SFES-I), a quick and easy-to-administer scale with seven items related to different activities of daily living (ADLs) both inside and outside the home. Each item is scored from 1 (not at all concerned about falling during the activity) to 4 (very concerned about falling during the activity). Total scores range from 7 (no concern about falling) to 28 (extremely concerned).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Nutritional status
Nutritional status will be assessed using the Short Form Mini Nutritional Assessment (MNA-SF). This consists of six brief questions covering key aspects of nutritional status. Total scores (maximum 14 points) classify participants as: normal nutritional status (12-14 points), at risk of malnutrition (8-11 points), or malnourished (0-7 points).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Cognitive status
Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE). This questionnaire assesses five dimensions: orientation, attention and calculation, memory, language, and praxis. Results are interpreted as follows: >24 points indicates no cognitive impairment, 19-23 points mild cognitive impairment, 14-18 points moderate cognitive impairment, and <14 points severe cognitive impairment.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Pain level
Pain will be assessed using the Pain Assessment in Advanced Dementia (PAINAD) scale. This evaluates five items: breathing, negative vocalisation, facial expression, body language, and consolability. Scores correspond to: 0-4 points mild pain, 5-7 points moderate pain, and 8-10 points severe pain. This scale can be used in patients with or without cognitive impairment.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Prediction of pressure ulcer risk
The Braden Scale will be used. This scale evaluates six dimensions: sensory perception, moisture, activity, mobility, nutrition, and friction/shear. A total score of ≤12 indicates high risk of developing pressure injuries, 13-14 indicates moderate risk, and ≥15 indicates low risk.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Quality of life among older adults
This will be assessed using the EQ-5D-5L questionnaire. The scale has two parts: a five-question survey and a visual analogue scale (VAS). The five questions measure health-related quality of life (HRQoL) in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) on a Likert scale (1 = no problems; 5 = extreme problems). Responses are converted into a single index value ranging from 0 (equivalent to death) to 1 (optimal health), applying Spanish population utility index values. The validated version for the general Spanish-speaking population will be used in this study.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Perceived social support
This will be assessed using the DUKE-UNC-11 Perceived Social Support Questionnaire (DUKE-11). The DUKE-11 is self-administered and measures perceived functional social support across 11 items divided into two dimensions: 'confidential support' and 'affective support'. All items use a five-point Likert scale (1 = as much as desired; 5 = much less than desired) to indicate the frequency of social support received. Scores range from 11-55 points, with scores >32 indicating low perceived social support.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Loneliness
Loneliness will be assessed using the three-item version of the UCLA Loneliness Scale (UCLA-3). The UCLA-3 measures subjective perception of loneliness through three items addressing key aspects of social disconnection. Participants respond using a three-point Likert scale (1 = never, 2 = sometimes, 3 = always). Total scores range from 3-9 points, with higher scores indicating greater perceived social isolation and lower scores indicating less loneliness.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Coping self-efficacy
This will be assessed using the Coping Self-Efficacy Scale (CSES). This scale measures an individual's perceived confidence in their ability to manage stressful or challenging situations. It comprises 26 items, each rated on an 11-point Likert scale (0 = "cannot do at all," 10 = "can do without difficulty"), grouped into three dimensions: use of coping strategies, emotional control, and positive thinking. Higher scores indicate greater perceived self-efficacy in coping with stress.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Emotional status
This will be measured using the Hospital Anxiety and Depression Scale (HADS), which assesses levels of anxiety and depression. The scale consists of 14 questions with four response options (0-3 points), seven items relating to anxiety and seven to depression. The maximum score for each subscale is 21, with a total maximum of 42 points. Scores above 11 on each subscale indicate the presence of anxiety or depression.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Glycated hemoglobin (HbA1c)
HbA1c (%) will be measured in blood samples as an indicator of long-term glucose metabolism.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fasting blood glucose
Fasting glucose concentration (mg/dL) will be measured in blood samples as an indicator of short-term glucose metabolism.
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
High-density lipoproteins (HDL)
Serum HDL cholesterol levels (mg/dL).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Low-density lipoproteins (LDL)
Serum LDL cholesterol levels (mg/dL).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Total cholesterol
Serum total cholesterol levels (mg/dL).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Omega-3 polyunsaturated fatty acids (N-3 PUFA)
Plasma concentration of N-3 PUFA (µmol/L).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Serum albumin
Serum albumin concentration (g/dL).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
C-reactive protein (CRP)
Serum CRP concentration (mg/L).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Interleukin-6 (IL-6)
Serum IL-6 concentration (pg/mL)
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Tumour necrosis factor-alpha (TNF-α)
Serum TNF-α concentration (pg/mL).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Gamma-glutamyl transferase (GGT)
Serum GGT activity (U/L).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Aspartate aminotransferase (AST)
Serum AST activity (U/L).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Alanine aminotransferase (ALT)
Serum ALT activity (U/L).
Measured: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Older adults who meet the inclusion criteria and voluntarily accept to participate in this study will be randomly allocated to one of two arms: intervention group (arm 1) or control group (arm 2). Participants from both arms will be assessed at the same time for data collection purposes (pre-test, post-test and 6-month follow-up) and they will be exposed to the experimental condition (intervention group) or the control condition (control group) at the same time for 12-weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Manuel Hernandez Padilla, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182747
- Sponsor's protocol ID
- A01037772
- Acronym
- CUIDAFRAIL
- Status last verified
- Jun 2026
- First submitted
- 5 Sep 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A database with the participants' total scores for the study's primary and secondary outcome measures will be made available to other researchers once all the papers presenting the study's results have been published.
Publications
Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
PubMed 34812790Lockwood EB, Schober M. Factors Influencing the impact of nurse practitioners' clinical autonomy: a self determining perspective. Int Nurs Rev. 2024 Jun;71(2):375-395. doi: 10.1111/inr.12948. Epub 2024 Apr 23.
PubMed 38651183Saunders R, Seaman K, Graham R, Christiansen A. The effect of volunteers' care and support on the health outcomes of older adults in acute care: A systematic scoping review. J Clin Nurs. 2019 Dec;28(23-24):4236-4249. doi: 10.1111/jocn.15041. Epub 2019 Sep 30.
PubMed 31429987de Sandes-Guimaraes LV, Dos Santos PC, Alves CPGP, Cervato CJ, Silva APA, Leao ER. The effect of volunteer-led activities on the quality of life of volunteers, residents, and employees of a long-term care institution: a cohort study. BMC Geriatr. 2023 Mar 20;23(1):151. doi: 10.1186/s12877-023-03898-y.
PubMed 36941534Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.
PubMed 29521871Garcia-Nogueras I, Aranda-Reneo I, Pena-Longobardo LM, Oliva-Moreno J, Abizanda P. Use of Health Resources and Healthcare Costs associated with Frailty: The FRADEA Study. J Nutr Health Aging. 2017;21(2):207-214. doi: 10.1007/s12603-016-0727-9.
PubMed 28112778Veronese N, Custodero C, Cella A, Demurtas J, Zora S, Maggi S, Barbagallo M, Sabba C, Ferrucci L, Pilotto A. Prevalence of multidimensional frailty and pre-frailty in older people in different settings: A systematic review and meta-analysis. Ageing Res Rev. 2021 Dec;72:101498. doi: 10.1016/j.arr.2021.101498. Epub 2021 Oct 23.
PubMed 34700009Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.
PubMed 31637940Kojima G, Iliffe S, Walters K. Frailty index as a predictor of mortality: a systematic review and meta-analysis. Age Ageing. 2018 Mar 1;47(2):193-200. doi: 10.1093/ageing/afx162.
PubMed 29040347Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.
PubMed 29575094Espinoza SE, Quiben M, Hazuda HP. Distinguishing Comorbidity, Disability, and Frailty. Curr Geriatr Rep. 2018 Dec;7(4):201-209. doi: 10.1007/s13670-018-0254-0. Epub 2018 Sep 19.
PubMed 30984516Milte R, Petersen J, Boylan J, Henwood T, Hunter S, Lange B, Lawless M, Torode S, Lewis LK. Prevalence and determinants of physical frailty among people living in residential aged care facilities: a large-scale retrospective audit. BMC Geriatr. 2022 May 14;22(1):424. doi: 10.1186/s12877-022-03101-8.
PubMed 35568811Kojima G. Frailty as a predictor of disabilities among community-dwelling older people: a systematic review and meta-analysis. Disabil Rehabil. 2017 Sep;39(19):1897-1908. doi: 10.1080/09638288.2016.1212282. Epub 2016 Aug 24.
PubMed 27558741Cesari M, Marzetti E, Thiem U, Perez-Zepeda MU, Abellan Van Kan G, Landi F, Petrovic M, Cherubini A, Bernabei R. The geriatric management of frailty as paradigm of "The end of the disease era". Eur J Intern Med. 2016 Jun;31:11-4. doi: 10.1016/j.ejim.2016.03.005. Epub 2016 Mar 18.
PubMed 26997416Holmberg C, Wolf A, Olsson MM, Heckemann B. Nurses' general attitudes and caregiving-specific perceptions toward the oldest-old: A nationwide survey. Int J Nurs Stud. 2022 Dec;136:104379. doi: 10.1016/j.ijnurstu.2022.104379. Epub 2022 Oct 10.
PubMed 36356546
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Multidisciplinary Intervention Programme Carried Out by Nursing and Physical Activity and Sports Sciences Students to Improve Frailty and Other Related Variables in Older Adults Living in Nursing Homes.
- ClinicalTrials.gov ID
- NCT07182747
- Acronym / sponsor ID
- CUIDAFRAIL / A01037772
- Conditions
- Frailty
- Keywords
- Frailty, older adults, intervention programme, Physical Activity, Activities of Daily Living, Nursing student, feasibility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND Frailty, regarded as a potentially reversible process and defined as a progressive deterioration of physiological systems and intrinsic capacity, constitutes a key risk factor for disability, dependency and institutionalisation.
Currently, it is estimated that between 50% and 75% of older adults living in residential care facilities present with frailty. This clinical profile is often directly associated with multiple comorbidities (around 65-85% of this population suffer from several chronic conditions), emotional decline, polypharmacy, malnutrition and a high prevalence of functional and cognitive impairment. Consequently, two out of every three older adults will require long-term care in specialised centres during their lifetime. In this context, nursing homes represent a key setting not only for providing care, but also for the prevention, detection and management of conditions such as frailty. However, care in residential facilities continues to focus on addressing established problems, with low participation in activities with potential benefits and a high perception of loneliness. Therefore, interventions in these contexts aimed at improving frailty are both necessary and urgent, particularly those that integrate a biopsychosocial approach, promote autonomy and foster active ageing.
Several studies have demonstrated that multidisciplinary intervention programmes and multicomponent physical training are effective in preventing frailty and its consequences. Nevertheless, their widespread implementation is limited by several factors. On the one hand, there is a lack of scientific evidence on the cost-effectiveness of such interventions, and on the other, healthcare systems face budgetary constraints in a context of increasing demand for geriatric care. In the search for more effective interventions to improve frailty and other related variables in older adults residing in nursing homes, supervised multidisciplinary programmes, delivered by health sciences students and implemented by nursing students, may represent a viable alternative. In this regard, students of Physical Activity and Sport Sciences (CAFYD) possess the knowledge required to design physical activity plans adapted to the capacities and needs of older adults. However, given the nature of their care role, nurses provide added value: their continuous presence in the clinical setting enables them to establish a closer therapeutic bond with the patient, ensure thorough monitoring of their progress, and facilitate coordination between physicians and other healthcare team members. These features make nurses key agents in the implementation of comprehensive, person-centred interventions.
Despite the potential of implementing a multidisciplinary intervention programme through health sciences students to improve frailty in older adults living in residential facilities, to the best of our knowledge, no similar interventions exist. Therefore, it is necessary to assess the feasibility of implementing such a proposal prior to conducting a randomised controlled trial to confirm its clinical effectiveness, as this approach plays an important role in determining the most appropriate trial design. To this end, different feasibility study guidelines recommend including variables such as acceptance, adherence and dropout rates as key markers for successful implementation.
STUDY'S HYPOTHESIS The main hypothesis of the CUIDAFRAIL project is that a supervised multidisciplinary intervention programme carried out by nursing and Physical Activity and Sport Sciences students is feasible for improving frailty and other related variables in older adults living in residential care facilities.
AIM AND OBJECTIVES The aim of the CUIDAFRAIL project is to examine the short- term and medium-term effects of a nursing students' multidisciplinary intervention programme on frailty among older adults living in nursing homes.
The secondary objectives of this project are the following:
- To examine the effects of the intervention on frailty, as well as other frailty-related variables, including physical fitness, functionality, fear of falling, emotional status, loneliness, social support and quality of life in older adults living in residential care facilities.
- To examine the effects on physiological and clinical parameters associated with frailty.
- To explore the perceptions and experiences of older adults participating in the programme upon completion.
- To explore the perceptions and experiences of nursing and Physical Activity and Sport Sciences students upon completion of the programme.
STUDY DESIGN A feasibility study will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Older adults who meet the inclusion criteria and voluntarily accept to participate in this study will be randomly allocated to one of two arms: intervention group (arm 1) or control group (arm 2). Participants from both arms will be assessed at the same time for data collection purposes (pre-test, post-test and 6-month follow-up) and they will be exposed to the experimental condition (intervention group) or the control condition (control group) at the same time for 12-weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nursing students' intervention programme, Behavioral: Standard care from Public Andalusian Health ServiceParticipants allocated to the 'intervention group' arm will receive the usual care offered by the Public Andalusian Healthcare Service in conjunction with a 12-week nursing students' intervention programme. |
| Control group | Active comparator | Behavioral: Standard care from Public Andalusian Health ServiceParticipants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years.
- Living in one of the institutions participating in the study.
- Signing the informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Requiring palliative care
- Having moderate or severe cognitive impairment (Pfeiffer Test >4); hypotension (systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg), anemia (hemoglobin level <9 g/dL), any acute metabolic disorder, uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg), uncontrolled arrhythmia, stable/unstable angina, uncontrolled chronic or metabolic disease, and advanced cerebrovascular or peripheral vascular disease
- Having undergone surgery within the last six weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing students' intervention programme12-week intervention programme conducted by nursing students and students trained in Sciences of Physical Activity and Sport (CAFYD). Participants will receive weekly three sessions of 45-60 minutes. It will include physical exercise and occupational therapy sessions aimed at improving frailty and other related outcomes in the participating older adults through interdisciplinary collaboration and ongoing monitoring. Nursing students will implement personalised intervention programmes designed by a multidisciplinary team comprising CAFYD students, an occupational therapist, and nurses experienced in the care of older adults. | Behavioural | Intervention group |
| Standard care from Public Andalusian Health ServiceThey will receive the standard care provided by the Andalusian Health Service as part of its portfolio of services offered to older adults residing in institutions, as well as the standard care provided by the institutions in which they live. As part of these services, older adults receive support such as accommodation, laundry, health promotion activities, health monitoring, assistance with activities of daily living, individual, group, and community social care, as well as means of communication with the outside world. The action plans or protocols established in care processes for older adults living in nursing homes do not include externally delivered multidisciplinary intervention programmes. | Behavioural | Control group, Intervention group |
Primary outcome
Adoption
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
The proportion of older adults who agree to participate out of the total number of older adults offered the programme. This information will be obtained from the records of eligible individuals and those ultimately included.
Adherence
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Adherence: The proportion of participants who complete at least 8 of the 12 weeks comprising the entire programme.
Dropout
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
The proportion of participants who withdraw from the intervention out of the total number of individuals who agreed to participate and began the programme.
Perceived quality of the intervention
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Assessed using the Net Promoter Scale (NPS), a tool used to measure user satisfaction with an intervention through the question: "How likely are you to recommend this to someone in a similar situation?" Scores range from 0 to 10, with scores below 5 indicating dissatisfaction and scores above 5 indicating satisfaction.
Frailty
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Clinical Frailty Scale (CFS). The CFS is a clinician-administered scale comprising nine levels that classify patients' degree of frailty. Each level describes a set of characteristics related to physical condition, functionality, and cognitive status, ranging from 1 (very fit) to 9 (terminally ill). Scores are assigned based on the patient's overall functioning in daily life, including mobility, dependence for basic and instrumental activities of daily living, presence of chronic diseases, and cognitive impairment. The scale has been validated in residential settings and can also be used in individuals with cognitive impairment, as it does not require self-reporting. Higher scores indicate greater frailty.
29 secondary outcomes
Physical condition (SPPB total score)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Physical condition (Timed Up and Go test)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Leg strength
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Grip strength
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fall risk
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Functionality
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fear of falling
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Nutritional status
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Cognitive status
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Pain level
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Prediction of pressure ulcer risk
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Quality of life among older adults
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Perceived social support
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Loneliness
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Coping self-efficacy
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Emotional status
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Glycated hemoglobin (HbA1c)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Fasting blood glucose
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
High-density lipoproteins (HDL)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Low-density lipoproteins (LDL)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Total cholesterol
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Omega-3 polyunsaturated fatty acids (N-3 PUFA)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Serum albumin
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
C-reactive protein (CRP)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Interleukin-6 (IL-6)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Tumour necrosis factor-alpha (TNF-α)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Gamma-glutamyl transferase (GGT)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Aspartate aminotransferase (AST)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Alanine aminotransferase (ALT)
Time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 34812790Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Background: PubMed 38651183Lockwood EB, Schober M. Factors Influencing the impact of nurse practitioners' clinical autonomy: a self determining perspective. Int Nurs Rev. 2024 Jun;71(2):375-395. doi: 10.1111/inr.12948. Epub 2024 Apr 23.
- Background: PubMed 31429987Saunders R, Seaman K, Graham R, Christiansen A. The effect of volunteers' care and support on the health outcomes of older adults in acute care: A systematic scoping review. J Clin Nurs. 2019 Dec;28(23-24):4236-4249. doi: 10.1111/jocn.15041. Epub 2019 Sep 30.
- Background: PubMed 36941534de Sandes-Guimaraes LV, Dos Santos PC, Alves CPGP, Cervato CJ, Silva APA, Leao ER. The effect of volunteer-led activities on the quality of life of volunteers, residents, and employees of a long-term care institution: a cohort study. BMC Geriatr. 2023 Mar 20;23(1):151. doi: 10.1186/s12877-023-03898-y.
- Background: PubMed 29521871Jadczak AD, Makwana N, Luscombe-Marsh N, Visvanathan R, Schultz TJ. Effectiveness of exercise interventions on physical function in community-dwelling frail older people: an umbrella review of systematic reviews. JBI Database System Rev Implement Rep. 2018 Mar;16(3):752-775. doi: 10.11124/JBISRIR-2017-003551.
- Background: PubMed 28112778Garcia-Nogueras I, Aranda-Reneo I, Pena-Longobardo LM, Oliva-Moreno J, Abizanda P. Use of Health Resources and Healthcare Costs associated with Frailty: The FRADEA Study. J Nutr Health Aging. 2017;21(2):207-214. doi: 10.1007/s12603-016-0727-9.
- Background: PubMed 34700009Veronese N, Custodero C, Cella A, Demurtas J, Zora S, Maggi S, Barbagallo M, Sabba C, Ferrucci L, Pilotto A. Prevalence of multidimensional frailty and pre-frailty in older people in different settings: A systematic review and meta-analysis. Ageing Res Rev. 2021 Dec;72:101498. doi: 10.1016/j.arr.2021.101498. Epub 2021 Oct 23.
- Background: PubMed 31637940Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.
- Background: PubMed 29040347Kojima G, Iliffe S, Walters K. Frailty index as a predictor of mortality: a systematic review and meta-analysis. Age Ageing. 2018 Mar 1;47(2):193-200. doi: 10.1093/ageing/afx162.
- Background: PubMed 29575094Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.
- Background: PubMed 30984516Espinoza SE, Quiben M, Hazuda HP. Distinguishing Comorbidity, Disability, and Frailty. Curr Geriatr Rep. 2018 Dec;7(4):201-209. doi: 10.1007/s13670-018-0254-0. Epub 2018 Sep 19.
- Background: PubMed 35568811Milte R, Petersen J, Boylan J, Henwood T, Hunter S, Lange B, Lawless M, Torode S, Lewis LK. Prevalence and determinants of physical frailty among people living in residential aged care facilities: a large-scale retrospective audit. BMC Geriatr. 2022 May 14;22(1):424. doi: 10.1186/s12877-022-03101-8.
- Individual participant dataSharing planned: Yes. A database with the participants' total scores for the study's primary and secondary outcome measures will be made available to other researchers once all the papers presenting the study's results have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing students' intervention programme in people with Frailty, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07182747, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.