Clinical trial NCT06404138: Recovery From Disability After Geriatric-home Rehabilitation Versus Standard of Care: Pilot Study
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disability Physical
Keywords: Disability
Geriatric
Rehabilitation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: CHU UCL Namur
First posted: 2024-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized 1:1 in one of the two intervention groups
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of recruitment - screening
timeFrame: 1 year
measure: Feasibility of recruitment - retainment
timeFrame: 1 year
measure: Feasibility of recruitment - reasons for non-participation
timeFrame: 1 year
measure: Feasibility of study procedures, assessments and data collection
timeFrame: 1 year
measure: Study participants' experience with the intervention
timeFrame: 1 year
measure: Physical therapists' experience with the intervention
timeFrame: 1 year
Secondary outcomes:
measure: The profiles of study participants
timeFrame: 1 year
measure: Time spent on study procedures and assessments
timeFrame: 1 year
measure: The study burden for participants (older persons)
timeFrame: 6 weeks
measure: The study burden for healthcare professionals
timeFrame: 1 year
measure: Physical therapists' experiences with the training protocol
timeFrame: 1 year
measure: Blinding of outcome assessors
timeFrame: 1 year
Other outcomes:
Locations:
city: Godinne
country: Belgium
facility: CHU UCL Namur
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Theo van Achterberg, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: