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Chronic DiseaseVISITAMENCT05264207

Nursing Students' Visits to Older Adults With Multiple Chronic Conditions

A study testing Nursing students' home-visit programme in people with Chronic Disease, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BACKGROUND The concurrence of multiple chronic conditions in older adults is associated with increased healthcare expenditure, increased hospital admissions, consultations and pharmaceutical expenditure. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Chronic Disease
What is being tested?
Nursing students' home-visit programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteSpain
Study dates
15 Mar 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

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.
  • Having been diagnosed with more than one chronic condition.
  • Living at home (community-dwelling).
  • Signing the informed consent to participate in the study.

Who cannot join

  • Having cognitive impairment (Pfeiffer test > 2 failures).
  • Having been diagnosed with a psychiatric condition (for example: schizophrenia).
  • Being a beneficiary of any of the services offered by the Fund of the Spanish National System for Autonomy and Support for Dependency.
  • Being a beneficiary of private personal assistance to help with functional dependency.
  • Participate in a program of similar nature from any public or private entities.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad de Almería

    Almería, 04120

Other trials in Spain

About this study

Official title: Nursing Students' Visits to Older Adults With Multiple Chronic Conditions: Effects on Self-care and Other Related Variables (VISITAME)

BACKGROUND

The concurrence of multiple chronic conditions in older adults is associated with increased healthcare expenditure, increased hospital admissions, consultations and pharmaceutical expenditure. Having been diagnosed with multiple chronic conditions is associated with biopsychosocial health deterioration, worsening quality of life and increased mortality in older adults. Consequently, older adults with multiple chronic conditions present complex health statuses that require healthcare professional to focus on promoting health and independence through self-care.

Read more

Available evidence suggests that the implementation of programs with individualized interventions focused on health promotion could improve self-care and other related variables in older people with chronic conditions. In this regard, the World Health Organization recommends the implementation of community health promotion programs including at least 5 home-visits carried out by healthcare professionals to promote self-care, independence, and quality of life amongst older adults with chronic conditions. However, the evidence on the cost-effectiveness of such visiting programs is inconsistent, which makes it difficult to integrate them into the services offered by public-funded healthcare systems. In search of more effective interventions to improve self-care and other related variables amongst older adults with multiple chronic conditions, nursing student visits could be a valid, effective alternative. Some studies suggest that the implementation of periodic follow-up programs (visits or telephone calls) by nursing students not only improves their knowledge and attitudes in relation to the care of older adults, but they could also have a positive impact on patients.

STUDY'S HYPOTHESIS

A program of supervised visits carried out by nursing students will significantly improve self-care behaviors and other related variables amongst older adults with multiple chronic conditions.

AIM

The aim of the VISITAME project is to examine the short-term (12 weeks) and medium-term (6 months) effects of a nursing students' home-visit programme on self-care behaviors amongst older adults with multiple chronic conditions.

STUDY DESIGN

A parallel two-arm randomized controlled trial (RCT) will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).

Conditions
Chronic Disease
Being tested
Nursing students' home-visit programme, Standard care from Public Andalusian Health Service
Keywords
chronic disease, older adult, self-care, home-visit, nursing student
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nursing students' home-visit programmeBehavioural

    12-week home-visit program conducted by nursing students. Participants will receive weekly 45-minute visits. The visits will aim to promote self-care behaviours and will focus on:

    1. Self-care of chronic conditions and medication management
    2. Healthy habits: physical activity and healthy eating
    3. Access to social support resources
    4. Patients' rights and autonomous decision-making

    The visits program will follow the WHO recommendations for the implementation of health promotion activities. All topics will be assigned 3 visits. In the first visit, the students will assess the participants' information needs and preferences in relation to the topic addressed and will provide generic information about it. In the second visit, the students will present individually-tailored information and will use individually-adapted strategies to convey such information. In the third visit, the student will explore the impact of the two previous visits and reinforce self-care behaviours.

  • Standard care from Public Andalusian Health ServiceBehavioural

    Standard care offered by the Public Andalusian Health Service in its portfolio of services for older adults with multiple chronic conditions and complex health conditions. As part of these services, older adults with multiple chronic conditions receive generic, written information on healthy eating, adapted physical activity, abandonment of toxic habits, environmental safety and emotional management when they are first diagnosed with a chronic condition. The action plans or protocols established in the care processes aimed at older people with chronic multimnorbidity do not include periodic home visits.

Study groups in NCT05264207
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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' home-visit programme.
Receives: Behavioral: Nursing students' home-visit programme; Behavioral: Standard care from Public Andalusian Health Service
Control groupActive comparatorParticipants 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.

  1. Change in self-care behaviours

    Self-care in chronic illness inventory (SC-CII). The SC-CII will be used to measure the primary outcome of the study: 'self-care behaviours'. The SC-CII is a self-administered inventory, comprised of 20 items divided into 3 scales. The self-care maintenance scale is comprised of 8 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-maintenance behaviors. The self-care monitoring scale is comprised of 5 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-monitoring behaviors. The 'self-care management' scale is comprised of 7 items that measure, on a five-point Likert scale (1=not at all likely, 5=very likely), the probability for a patient to perform health-management behaviors. The scores of the three tools are calculated individually (between 0 and 100). Higher scores are indicative of better self-care.

    Measured: Changes from baseline to 3-month and 6-month follow-up

Secondary outcomes (12)

  1. Change in self-efficacy in self-care

    The participants' self-efficacy in self-care will be assessed with the Self-Efficacy in Self-Care Scale (SESCS). The SESCS is comprised of 10 items that can be responded using a 5-point, Likert type scale (1=not confident; 5=extremely confident) and assess self-efficacy related to self-care maintenance, monitoring, and management in people diagnosed with chronic conditions. The participants' total scores will be standardised to range from 0-100, with higher scores indicating higher levels of self-efficacy.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  2. Change in loneliness

    UCLA Loneliness Scale (UCLA). UCLA will be used to measure the variable 'loneliness'. This self-administered scale measures how often older people experience feelings of loneliness. The UCLA is comprised of 10 items to be answered using a 4-point Likert scale (1=I often feel this way, 4=I never feel this way). Lower scores are indicative of a greater feeling of loneliness. It is suggested that scores <20 points could indicate severe loneliness, while scores of 20-30 points could be indicative of moderate loneliness.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  3. Change in perceived social support

    DUKE-UNK-11 questionnaire of perceived social support (DUKE-11). The DUKE-11 will be used to measure the variable 'perceived social support'. The DUKE-11 questionnaire is self-administered and measures perceived functional social support with 11 items divided into two dimensions: 'confidant support' and 'affective support'. All items have 5 response options in Likert format (1=as much as I want, 5=much less than I want) and allow participants to indicate the frequency with which they receive social support. Scores can range from 11-55 points. Scores >32 points indicate low perceived social support.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  4. Change in funcional capacity for activities of daily living

    Barthel Index (BI). The BI will be used to measure the variable 'functional independence' to carry out the BADL. The BI is a unidimensional, hetero-administered questionnaire with 10 items measuring participants' independence for feeding, moving from chair to bed, doing personal toileting, getting on and off the toilet, bathing oneself, walking on a level surface or propelling a wheelchair, ascending and descending stairs, dressing and undressing, continence of bowels, and controlling bladder. The assessor can complete the questionnaire by direct observation or by interviewing the participant. The score can range from 0-100 (90 for people in wheelchairs) and the level of functional independence is determined by the score obtained: independent (100 points), mild dependency (≥ 60 points), moderate dependency (40-55 points), severe dependency (20-35 points), total dependency (< 20 points).

    Measured: Changes from baseline to 3-month and 6-month follow-up

  5. Change in nutritional status

    Nutritional status will be assessed using the Mini Nutritional Assessment (MNA). The MNA is comprised of 18 items divided in two sections: screening and assessment. The screening section is comprised of 6 items that assess and will yield a total screening score that can be interpreted: a score ≥ 12 indicates the person is well nourished, a score of 8-11 indicates the person is at risk of malnutrition, and a score ≤ 7 indicates the person is malnourished. When the person's score ≤ 11, it is recommended to complete the assessment section to determine the factors that could be affecting their nutritional status. The assessment section is comprised of 12 weighted items (0-2 points per item) that must be added to the screening score to calculate a total MNA score. A person with a total MNA score of 24-30 is considered to have a normal nutritional status, whereas people with a total MNA score of 17-23.5 is at risk of malnourishment and people with a total MNA score < 17 are malnourished.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  6. Change in diet quality

    The participants' diet quality will be assessed using the Mediterranean Diet Adherence Screener (MEDAS). The MEDAS is comprised of 14 items that measure the degree of adherence to the typical Mediterranean dietary pattern. The MEDAS includes 12 questions on food consumption frequency and 2 questions on food intake habits considered typical of the Spanish Mediterranean diet. Each question is scored 0 or 1. A total score ≥ 9 indicates good adherence to the Mediterranean Diet.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  7. Change in health-related quality of life

    SF-12 quality of life questionnaire (SF-12). The SF-12 questionnaire will be used to measure the variable 'quality of life'. The SF-12 is a self-administered questionnaire that measures health-related quality of life in 12 items. The SF-12 is the shortened version of the SF-36. The SF-12 response options follow a Likert-type scale that assesses intensity or frequency, depending on the item. The number of response options for each item ranges from three to six and the total score must be transformed from 0 to 100. Higher scores indicate better health-related quality of life.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  8. Change in dignity

    Patient Dignity Inventory (PDI). The PDI will be used to measure the 'dignity' variable. The PDI is a self-administered instrument comprised of 25 items that are distributed in 3 dimensions: 'psychological and existential stress', 'physical symptoms and dependency' and 'social support'. Using a 5-point Likert scale (1=Not a problem, 5=Overwhelming problem), participants must respond to what degree certain situations related to dignity have been a problem or concern for them in the last few days. Higher scores indicate greater affectation in the participants' sense of dignity.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  9. Change in personal autonomy

    Maastricht Personal Autonomy Questionnaire (MPAQ). The MPAQ is a self-administered questionnaire comprised of 16 items divided into 3 dimensions. The 'dilemmas' dimension (6 items) measures the frequency with which older people experience conflicts between what they want to do and what is best for their health (1=never; 5=very often). The 'degree of autonomy' dimension measures the impact of dilemmas on the participants' autonomy (1=Not at all; 5=Yes, completely). The dimension 'working on autonomy' (5 items) measures the efforts made by the participants to maintain personal autonomy (1=No, not at all; 5=Yes, I do everything possible),. The total score of each dimension is calculated by adding the score of all the items and dividing it by the total number of items. Higher scores indicate that people face dilemmas more often, experience a greater degree of autonomy, and work harder to maintain or achieve their autonomy.

    Measured: Changes from baseline to 3-month and 6-month follow-up

  10. Change in falls

    Number and place of falls in the last 6 months

    Measured: Changes from baseline to 3-month and 6-month follow-up

  11. Change in hospital admissions

    Number and cause of hospital admissions in the last 6 months

    Measured: Changes from baseline to 3-month and 6-month follow-up

  12. Change in visits to emergency departments

    Number and cause of visits to the emergency department in the last 6 months

    Measured: Changes from baseline to 3-month and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start15 Mar 2022
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

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
Supportive care
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
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05264207
Sponsor's protocol ID
PID2020-117579RA-I00
Acronym
VISITAME
Status last verified
Dec 2023
First submitted
14 Feb 2022
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party (j.hernandez-padilla@ual.es)

Publications

  • Foguet-Boreu Q, Violan C, Rodriguez-Blanco T, Roso-Llorach A, Pons-Vigues M, Pujol-Ribera E, Cossio Gil Y, Valderas JM. Multimorbidity Patterns in Elderly Primary Health Care Patients in a South Mediterranean European Region: A Cluster Analysis. PLoS One. 2015 Nov 2;10(11):e0141155. doi: 10.1371/journal.pone.0141155. eCollection 2015.

    PubMed 26524599

  • Garin N, Olaya B, Perales J, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Multimorbidity patterns in a national representative sample of the Spanish adult population. PLoS One. 2014 Jan 20;9(1):e84794. doi: 10.1371/journal.pone.0084794. eCollection 2014.

    PubMed 24465433

  • Palladino R, Tayu Lee J, Ashworth M, Triassi M, Millett C. Associations between multimorbidity, healthcare utilisation and health status: evidence from 16 European countries. Age Ageing. 2016 May;45(3):431-5. doi: 10.1093/ageing/afw044. Epub 2016 Mar 24.

    PubMed 27013499

  • Picco L, Achilla E, Abdin E, Chong SA, Vaingankar JA, McCrone P, Chua HC, Heng D, Magadi H, Ng LL, Prince M, Subramaniam M. Economic burden of multimorbidity among older adults: impact on healthcare and societal costs. BMC Health Serv Res. 2016 May 10;16:173. doi: 10.1186/s12913-016-1421-7.

    PubMed 27160080

  • Laires PA, Perelman J. The current and projected burden of multimorbidity: a cross-sectional study in a Southern Europe population. Eur J Ageing. 2018 Sep 1;16(2):181-192. doi: 10.1007/s10433-018-0485-0. eCollection 2019 Jun.

    PubMed 31139032

  • Buja A, Rivera M, De Battisti E, Corti MC, Avossa F, Schievano E, Rigon S, Baldo V, Boccuzzo G, Ebell MH. Multimorbidity and Hospital Admissions in High-Need, High-Cost Elderly Patients. J Aging Health. 2020 Jun/Jul;32(5-6):259-268. doi: 10.1177/0898264318817091. Epub 2018 Dec 6.

    PubMed 30522388

  • McPhail SM. Multimorbidity in chronic disease: impact on health care resources and costs. Risk Manag Healthc Policy. 2016 Jul 5;9:143-56. doi: 10.2147/RMHP.S97248. eCollection 2016.

    PubMed 27462182

  • Bahler C, Huber CA, Brungger B, Reich O. Multimorbidity, health care utilization and costs in an elderly community-dwelling population: a claims data based observational study. BMC Health Serv Res. 2015 Jan 22;15:23. doi: 10.1186/s12913-015-0698-2.

    PubMed 25609174

  • Williams JS, Egede LE. The Association Between Multimorbidity and Quality of Life, Health Status and Functional Disability. Am J Med Sci. 2016 Jul;352(1):45-52. doi: 10.1016/j.amjms.2016.03.004. Epub 2016 Mar 18.

    PubMed 27432034

  • Gu J, Chao J, Chen W, Xu H, Zhang R, He T, Deng L. Multimorbidity and health-related quality of life among the community-dwelling elderly: A longitudinal study. Arch Gerontol Geriatr. 2018 Jan;74:133-140. doi: 10.1016/j.archger.2017.10.019. Epub 2017 Oct 28.

    PubMed 29096228

  • Bao XY, Xie YX, Zhang XX, Peng X, Huang JX, Du QF, Wang PX. The association between multimorbidity and health-related quality of life: a cross-sectional survey among community middle-aged and elderly residents in southern China. Health Qual Life Outcomes. 2019 Jun 24;17(1):107. doi: 10.1186/s12955-019-1175-0.

    PubMed 31234889

  • Makovski TT, Schmitz S, Zeegers MP, Stranges S, van den Akker M. Multimorbidity and quality of life: Systematic literature review and meta-analysis. Ageing Res Rev. 2019 Aug;53:100903. doi: 10.1016/j.arr.2019.04.005. Epub 2019 Apr 30.

    PubMed 31048032

  • Liu J, Yu W, Zhou J, Yang Y, Chen S, Wu S. Relationship between the Number of Noncommunicable Diseases and Health-Related Quality of Life in Chinese Older Adults: A Cross-Sectional Survey. Int J Environ Res Public Health. 2020 Jul 17;17(14):5150. doi: 10.3390/ijerph17145150.

    PubMed 32708844

  • Makovski TT, Le Coroller G, Putrik P, Choi YH, Zeegers MP, Stranges S, Ruiz Castell M, Huiart L, van den Akker M. Role of clinical, functional and social factors in the association between multimorbidity and quality of life: Findings from the Survey of Health, Ageing and Retirement in Europe (SHARE). PLoS One. 2020 Oct 20;15(10):e0240024. doi: 10.1371/journal.pone.0240024. eCollection 2020.

    PubMed 33079931

  • Nunes BP, Flores TR, Mielke GI, Thume E, Facchini LA. Multimorbidity and mortality in older adults: A systematic review and meta-analysis. Arch Gerontol Geriatr. 2016 Nov-Dec;67:130-8. doi: 10.1016/j.archger.2016.07.008. Epub 2016 Aug 2.

    PubMed 27500661

Questions about this trial

What is this clinical trial studying?

A study testing Nursing students' home-visit programme in people with Chronic Disease, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 20 Dec 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in self-care behaviours (time frame: Changes from baseline to 3-month and 6-month follow-up). 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 NCT05264207, which also lists 64 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 20 Dec 2023.

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