Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study

Disability Physical Clinical Trial

— RECOVER@HOME  

Official title:

Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study for a Randomised Multicentre Parallel Group Pragmatic Trial in Older Persons With Disability at Hospital Discharge.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404138
• Other study ID #: S65872
• Secondary ID: KCE22-1383
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Birgit Coucke, MSc, PhD
• Phone: +3216373301
• Email: recoverathome[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At discharge after a hospitalization, many older people are not as able as before their hospital stay and have difficulty performing their daily activities at home. For example, washing and dressing themselves, housework or shopping are often more difficult after discharge from hospital. However, most older people do not receive any support in regaining their physical status and self-reliance. As a result, they often need permanent help from informal or professional caregivers. Their quality of life is also impacted and they have an increased risk of new hospital admissions.

Rehabilitation centers and hospital rehabilitation wards help the elderly to regain their daily functioning, but the number of places is very limited. This means that support for home rehabilitation is necessary for the vast majority of older people (almost 82,000 people per year). However, most of the time there is no support for home rehabilitation and the effect of such home rehabilitation programs has been little studied. Although studies show that home rehabilitation can improve physical functioning, the effect on impairments in daily activities and the quality of life of older people are not clear.

In a future multicenter RCT, the investigators want to study whether training and guidance by a physiotherapist contributes to the recovery of older people after discharge from hospital.

Patients will either receive standard care after hospitalization discharge, or intensive guidance from a physiotherapist. The patients guided by the physiotherapist are trained and supervised three times a week, for six weeks, to improve their muscle strength, balance, walking and mobility. The aim of the intensive home rehabilitation program is that the individual benefits from it in the longer term. Therefore, whether individuals who received the program are less limited in their daily functioning than those who did not receive the intensive rehabilitation program is checked after six months. In addition, the quality of life, physical functioning and healthcare costs for these two groups are also compared.

To ensure that the study is feasible, a small pilot study will first be performed. Here, the aim is to assess the feasibility of recruitment (screening and retaining participants, reasons for refusal and participant profiles), study procedures and intervention. This includes time registration by the study team and physiotherapists, assessment of study burden and experiences with the execution of the protocol. The findings of this pilot study will help deciding about progressing to a future definitive RCT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: July 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 75 years of age or older;

• disability (i.e., dependent in one or more activities of daily living) at hospital discharge;

• rehabilitation potential;

• capable of giving informed consent, and also giving their consent;

Exclusion Criteria:

• discharged to a nursing home or rehabilitation centre;

• receiving palliative care;

• enrolled in a specialised rehabilitation programme, e.g. cardiac rehabilitation, stroke rehabilitation, respiratory rehabilitation for COPD, and oncology rehabilitation;

• in active follow-up with a physical therapist, and for whom participation in the intervention would be too demanding or would compromise the integrity of the therapy and its anticipated outcomes.

Related Conditions & MeSH terms

• Disability Physical

Intervention

Other:
• The Geriatric Activation Program (GAPP) Home version
The rehabilitation at home intervention consists of three 45 minutes session per week (total of 18 sessions) with a different focus for each session. The therapy is goal-oriented and includes functional exercises in the home where possible (e.g. transfers such as getting out of bed, walking to the toilet etc.). There are three sessions per week: 1 for training strength, 1 for training balance and 1 for speed, coordination and endurance. Each session will start with gait rehabilitation as a warming-up. For each session, a set of exercises with varying levels of difficulty is available. As rehabilitation needs are diverse, the therapist is expected to choose the most appropriate exercise and the difficulty level of the exercise for the individual older person. This also includes scaling the exercises to the individual progression of the older person.
• Standard of care
Standard of care, without any restrictions.

Locations

Country	Name	City	State
Belgium	CHU UCL Namur	Godinne
Belgium	UZ Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	CHU UCL Namur

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment - screening	The number of potential participants screened/not screened for inclusion.	1 year
Primary	Feasibility of recruitment - retainment	The number of (potential) participants recruited/not recruited, randomised and retained (frequency and proportion of participants that are randomized and completed 6w follow up).	1 year
Primary	Feasibility of recruitment - reasons for non-participation	Potential participants' reasons for refusing to participate (qualitative), expressed in frequency per reason for declining participation.	1 year
Primary	Feasibility of study procedures, assessments and data collection	Assessment will focus on the timeliness and practicality of the randomisation, assessment and the data collection in the participants' home, processing and managing the data and study administration. This endpoint is assessed through interviewing study staff about their experiences.	1 year
Primary	Study participants' experience with the intervention	Semi-structured interviews with participants, assessing how the intervention did or did not meet their needs, intervention elements they did or did not appreciate, their perceived adherence to the therapy sessions, the level of difficulty of intervention elements in relation to their level of disability, the support from their therapist, the perceived benefit or lack thereof, their reasons for engaging or discontinuing the intervention, and reasons for (not) recommending the intervention to others in the same position.	1 year
Primary	Physical therapists' experience with the intervention	Interviews with physical therapists, addressing feasibility with a view to alternative elements of the intervention, the target group, the setting and their professional capabilities and limitations. Questions will also explore their experience with the adherence of the participants, and their perceptions regarding factors that influenced this.	1 year
Secondary	The profiles of study participants	Reason for hospital admission, unit, emergency/intensive care or surgery during hospitalization (frequencies and proportions).	1 year
Secondary	Time spent on study procedures and assessments	The study nurses and medical doctors participating in the study will log the time they spend on the study in an electronic logbook. This will be done for patient 5 to 12 at each site. Time will be recorded in minutes per day, and will be stratified for screening, informed consent, randomisation, baseline visit, visit at 6 weeks follow-up, administration, and other. Data will be gathered up to six weeks when the intervention protocol is completed and follow-up data at six weeks are gathered. The endpoint will be expressed as the median time to complete the study procedures per participant.	1 year
Secondary	The study burden for participants (older persons)	Audio recorded interviews using open-ended questions will focus on understanding how persons experience study participation and which aspects of the study might be perceived as hindrances or barriers in relation to their daily lives.Second, a modified version of the Perceived Research Burden Assessment instrument (5-point Likert scales) is used to quantify the study burden for individual participants.	6 weeks
Secondary	The study burden for healthcare professionals	Structured interviews, focusing on understanding how they experienced screening for eligibility and how this could be disruptive for their daily practice.	1 year
Secondary	Physical therapists' experiences with the training protocol	Physical therapists' experiences with the training needed to deliver the rehabilitation protocol will be assessed in a structured interview. Interview questions will focus on the format, the delivery, the content, and the duration of the training. Participants will also be asked to suggest changes or improvements. The interview is performed online and after completion of the training, and is audio recorded.	1 year
Secondary	Blinding of outcome assessors	Structured interview addressing for which participants the study nurses feel they know, suspect or do not know to which group a person was randomized, and -if relevant- how they found out. Nurses' ideas of group allocation will be checked against the actual group allocation. This information will be used to construct a Blinding Index. This endpoint will be expressed as the frequency and proportion of participants where blinding was not achieved.	1 year

External Links

•   Trial description on funder web page