Hip FracturesActiveHipNCT04859309
Activating Older People After a Hip Fracture
A study testing ActiveHip+ mobile application in people with Hip Fractures, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- ActiveHip+ mobile application
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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
- Have hip fracture surgery
- Age equal to or greater than 65 years
- Are allowed weight-bearing at 48 hours after surgery
- Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure [FIM] index scored more than 90 points)
- Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
- Basic management of the mobile phone
- Have signed an informed consent.
Who cannot join
- Presence of low cognitive level (Pfeiffer test score lower than 4 points)
- Being dependent on the activities of daily living before the hip (Functional Independence Measure [FIM] index scored less than 60 points)
- Being institutionalized
- Post-surgery complications
- Terminal disease
- Age under 65 years
Trial locations and contacts
1 site in 1 country.
Spain1 site
Andalusian Public Health System
Granada, 18013
Patrocinio Ariza-Vega, PhD, +34 637205620, pariza@ugr.es
About this study
The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.
The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.
- Conditions
- Hip Fractures
- Being tested
- ActiveHip+ mobile application, Standard care in a hip fracture
- Keywords
- Tele-rehabilitation, Occupational therapy, Physiotherapy, Physical exercise, Function, Quality of life, Informal Caregiver burden, Information and Communication Technologies
- Medical subject headings
- Hip Fractures, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveHip+ mobile applicationBehavioural
The mobile application with the educational and multidisciplinary tele-rehabilitation program.
Standard care in a hip fractureProcedure or surgery
The participants of this group will receive the standard treatment for a hip fracture in the Andalusian healthcare system.
| Study group | Role | What they receive |
|---|---|---|
| ActiveHip Intervention | Experimental | The ActiveHip tele-rehabilitation mobile application.
The program consists of a multidisciplinary home-based tele-rehabilitation program delivered through a mobile application. It is comprised by an occupational therapy program and a physical exercise program.
The intervention group have the opportunity to perform three online-based sessions per week (two sessions of physical exercise and one of occupational therapy), each lasting 30-60 min. It is able to realize a fourth session, called "bonus session".
In addition, the intervention group will receive the educational program, which has a total of 7 modules. 5 modules are for patients and caregivers, and 2 modules are specific for caregivers. Receives: Behavioral: ActiveHip+ mobile application |
| Standard care | Active comparator | Participants of this group will receive the standard care for hip fracture patients at hospital discharge. Receives: Procedure: Standard care in a hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery (SPPB)
The SPPB is one of the most commonly used instruments for measuring physical performance in population studies. The SPPB assessment has previously been used to evaluate the mobility of older people and patients with a hip fracture. The performance battery consists of three tasks: balance, walking, and chair stands. The SPPB tests of balance, including time to walk 4 meters and time required to stand from a chair 5 times. The score ranges from 0 to 12 points, with higher scores indicating better mobility. Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living, loss of mobility, disability, hospitalization duration of stay in the hospital, admission to nursing facilities, and death. Internal consistency is high, with Cronbach's α = 0.87.
Measured: The primary outcome will be followed over 12 weeks.
Secondary outcomes (10)
EuroQoL 5D Quality of Life questionnaire
The EuroQol (EQ-5D) is a patient-reported outcome measure used to evaluate the generic quality of life of the patient. The questionnaire comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 possible levels: no problems, some problems, and extreme problems. To obtain a total score index, the EuroQol Group provides a calculator called "EQ-5D-5L Crosswalk Index Value Calculator" which is based on several studies conducted in 6 different countries (Spain among them). Additionally, it includes the EQ visual analog scale (EQ-VAS) in which the patients self-rated her/his health on a vertical analog scale from 0 (the worst health status) to 100 (the best health status).
Measured: 12 weeks
Functional Independence Measure
The Functional Independence Measure score reflects the level of assistance a person needs in activities of daily living. The measure consists of 18 items, of which 13 concern physical activities divided into four categories: self-care, sphincter control, mobility, and locomotion. The remaining five items relate to aspects of cognitive and social functioning divided in two categories: communication and social cognition. The total functional independence measure score range is between 18 and 126 points. Higher scores indicate a higher level of independence.
Measured: 12 weeks
Short Falls Efficacy Scale-International (SFES-I)
The SFES-I test is used to evaluate patients' fear of falling when performing ADLs. The scale consists of seven items with four possible answers corresponding to the level of concern. The total score range is from 7 to 28 points, with a higher score indicating a higher level of fear of falling. The internal consistency of the SFES-I is very high with Cronbach's α = 0.92.
Measured: 12 weeks
New Mobility Score (NMS)
The New Mobility Score (NMS) is an easy-to-administer measure of functional ability and is used worldwide as a hip fracture (HF) score. The NMS consists of three questions to measure walking mobility across daily life activities; Indoor walking, outdoor walking; and walking during shopping which evaluates the pre-fracture functional level with a score from 0 (not able to walk) to 9 (fully independent). The inter-tester reliability of the New Mobility Score is very high and can be recommended to evaluate the pre-fracture functional level in patients with acute hip fracture. The internal consistency of the NMS is good with Cronbach's α, closer to 1.
Measured: 12 weeks
The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer
The SPMSQ this test has 10 items that assess various functions: orientation, recall memory, concentration, and calculation. Very brief but with an acceptable discriminatory capacity. The SPMSQ test has good reliability and validity. For clinical use, a cut-off of 3 appears to be most useful. When illiterate patients are assessed, it is recommended to employ a cut-off of 4 or more. The internal consistency of the SPMSQ is good with Cronbach's α, = 0,82.
Measured: 12 weeks
Visual Analogue Scale for Pain (VAS Pain)
The VAS Pain test is a fast and convenient way to evaluate the intensity of pain perceived by the patient. The patient indicates the perceived pain by pointing out on a physical scale a value from 0 (without pain) to 10 (maximum pain) (Boonstra, Schiphorst Preuper, Reneman, Posthumus, \& Stewart, 2008). The test-retest reliability is good with r = 0.71 for illiterate patients and r = 0.94 for literate patients.
Measured: 12 weeks
The Hospital Anxiety and Depression Scale (HADS)
The HADS is administered to assess the presence of anxiety and depression in both patients and caregivers. The scale consists of 14 items, each with four possible answers (0-3 points), divided into two subscales: seven items for the status of depression and the remaining items for the presence of anxiety. The maximum score of each subscale is 21 points, with scores below 11 indicating the presence of depression or anxiety. The internal consistency of the HADS is good with Cronbach's α = 0.80.
Measured: 12 weeks
International Fitness Scale (IFIS)
The IFIS is a simple evaluation scale consisting of five questions concerning the patient's perception of his/her general physical condition (cardio-respiratory fitness, muscular strength, agility, and flexibility). Each question has five possible answers (very poor, poor, average, good, and very good) scored from 1 to 5 points, with the highest score corresponding to the best perception of physical condition. The test-retest reliability of the IFIS, as measured by the average weighted Kappa, is 0.45.
Measured: 12 weeks
Zarit Burden Interview
The Zarit Burden Interview assessment includes 22 questions related to aspects of caregiver burden, including mood, physical state, economic situation, and social state, as well as the feelings of the caregiver when giving attention and care to the patient. The questions have five possible answers: 0 = never, 1 = almost never, 2 = sometimes, 3 = quite often, and 4 = almost always. The total score ranges from 0 to 88 points, with 46 points or lower indicating no burden, moderate burden between 47 and 55 points, and intense burden with 56 points or more. The internal consistency of the Zarit Burden Interview has been found to be good, with Cronbach's α = 0.86.
Measured: 12 weeks
The Low Back Pain Disability Scale (Oswestry)
Oswestry test is a self-administered questionnaire specific to low back pain that measures limitations in daily activities. It consists of 10 questions with 6 answer possible each. The internal consistency of the Oswestry test with Cronbach's α, = 0.82.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Institut de formació contínua - IL3, University of Barcelona, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, EIT Health, Biohealth Research Institute in Granada (ibs.GRANADA)
- Responsible party
- Principal investigator, Patrocinio Ariza Vega, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859309
- Sponsor's protocol ID
- Andalusian Health System
- Acronym
- ActiveHip
- Status last verified
- May 2021
- First submitted
- 19 Apr 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prieto-Moreno R, Mora-Traverso M, Estevez-Lopez F, Molina-Garcia P, Ortiz-Pina M, Salazar-Gravan S, Cruz-Guisado V, Gago ML, Martin-Matillas M, Ariza-Vega P. Effects of the ActiveHip+ mHealth intervention on the recovery of older adults with hip fracture and their family caregivers: a multicentre open-label randomised controlled trial. EClinicalMedicine. 2024 Jun 7;73:102677. doi: 10.1016/j.eclinm.2024.102677. eCollection 2024 Jul.
PubMed 38911836
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Older People After a Hip Fracture
- ClinicalTrials.gov ID
- NCT04859309
- Acronym / sponsor ID
- ActiveHip / Andalusian Health System
- Conditions
- Hip Fractures
- Keywords
- Tele-rehabilitation, Occupational therapy, Physiotherapy, Physical exercise, Function, Quality of life, Informal Caregiver burden, Information and Communication Technologies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Amgen, Institut de formació contínua - IL3, University of Barcelona, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental, EIT Health, Biohealth Research Institute in Granada (ibs.GRANADA)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Apr 2021 (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.
The main aim of this study is to determine if the ActiveHip tele-rehabilitation mobile application improves the functional level and the quality of life of patients who undergone hip surgery after a fracture.
The second aim is to determine if the ActiveHip intervention reduce the anxiety, stress and burden of the caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ActiveHip Intervention | Experimental | Behavioral: ActiveHip+ mobile applicationThe ActiveHip tele-rehabilitation mobile application. The program consists of a multidisciplinary home-based tele-rehabilitation program delivered through a mobile application. It is comprised by an occupational therapy program and a physical exercise program. The intervention group have the opportunity to perform three online-based sessions per week (two sessions of physical exercise and one of occupational therapy), each lasting 30-60 min. It is able to realize a fourth session, called "bonus session". In addition, the intervention group will receive the educational program, which has a total of 7 modules. 5 modules are for patients and caregivers, and 2 modules are specific for caregivers. |
| Standard care | Active comparator | Procedure: Standard care in a hip fractureParticipants of this group will receive the standard care for hip fracture patients at hospital discharge. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Have hip fracture surgery
- Age equal to or greater than 65 years
- Are allowed weight-bearing at 48 hours after surgery
- Had a high pre-fracture functional level the week before the fracture (Functional Independence Measure [FIM] index scored more than 90 points)
- Have an informal or family caregiver who has the ability to access the Internet to use the app ActiveHip+
Key exclusion criteria (6 listed)
- Presence of low cognitive level (Pfeiffer test score lower than 4 points)
- Being dependent on the activities of daily living before the hip (Functional Independence Measure [FIM] index scored less than 60 points)
- Being institutionalized
- Post-surgery complications
- Terminal disease
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 |
|---|---|---|
| ActiveHip+ mobile applicationThe mobile application with the educational and multidisciplinary tele-rehabilitation program. | Behavioural | ActiveHip Intervention |
| Standard care in a hip fractureThe participants of this group will receive the standard treatment for a hip fracture in the Andalusian healthcare system. | Procedure or surgery | Standard care |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: The primary outcome will be followed over 12 weeks.
The SPPB is one of the most commonly used instruments for measuring physical performance in population studies. The SPPB assessment has previously been used to evaluate the mobility of older people and patients with a hip fracture. The performance battery consists of three tasks: balance, walking, and chair stands. The SPPB tests of balance, including time to walk 4 meters and time required to stand from a chair 5 times. The score ranges from 0 to 12 points, with higher scores indicating better mobility. Low scores on the SPPB have a high predictive value for a wide range of health consequences including disability in Activities of Daily Living, loss of mobility, disability, hospitalization duration of stay in the hospital, admission to nursing facilities, and death. Internal consistency is high, with Cronbach's α = 0.87.
10 secondary outcomes
EuroQoL 5D Quality of Life questionnaire
Time frame: 12 weeks
Functional Independence Measure
Time frame: 12 weeks
Short Falls Efficacy Scale-International (SFES-I)
Time frame: 12 weeks
New Mobility Score (NMS)
Time frame: 12 weeks
The Short Portable Mental State Questionnaire (SPMSQ) of Pfeiffer
Time frame: 12 weeks
Visual Analogue Scale for Pain (VAS Pain)
Time frame: 12 weeks
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
International Fitness Scale (IFIS)
Time frame: 12 weeks
Zarit Burden Interview
Time frame: 12 weeks
The Low Back Pain Disability Scale (Oswestry)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 38911836Prieto-Moreno R, Mora-Traverso M, Estevez-Lopez F, Molina-Garcia P, Ortiz-Pina M, Salazar-Gravan S, Cruz-Guisado V, Gago ML, Martin-Matillas M, Ariza-Vega P. Effects of the ActiveHip+ mHealth intervention on the recovery of older adults with hip fracture and their family caregivers: a multicentre open-label randomised controlled trial. EClinicalMedicine. 2024 Jun 7;73:102677. doi: 10.1016/j.eclinm.2024.102677. eCollection 2024 Jul.
- Related InfoLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveHip+ mobile application in people with Hip Fractures, run by Universidad de Granada 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrocinio Ariza Vega, PhD (0034637205620, pariza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: The primary outcome will be followed over 12 weeks.). 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 NCT04859309, which also lists 1 linked publication.
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 24 May 2021.