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| ID | Type | Description | Link |
|---|---|---|---|
| KCE22-1383 | Other Grant/Funding Number | KCE |
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| Name | Class |
|---|---|
| CHU UCL Namur | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Receives 18 physiotherapy sessions at home over 6 weeks according to the Geriatric Activation program Pellenberg (GAPP, see intervention) |
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| Control group | Other | Older persons in the control group receive the standard of care, without any restrictions. This implies that some of the older persons in the control group could receive physical therapy, but the standard of care implies that although geriatricians regularly prescribe physical therapy the therapy is actually not started in most cases. Therefore, physical therapy will not often be delivered in the control group, and if it is delivered it will be less structured and at lower intensity and/or frequency. Moreover, physical therapy delivered to participants in the control group will not be supported by a targeted rehabilitation plan and a specific training for the therapists. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Geriatric Activation Program (GAPP) Home version | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment - screening | The number of potential participants screened/not screened for inclusion. | 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| Physical therapists' experience with the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The profiles of study participants | Demographic information | 1 year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theo van Achterberg, MSc, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU UCL Namur | Godinne | 5530 | Belgium | |||
| UZ Leuven |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40544287 | Derived | Van Grootven B, van Dijk M, Islam F, Coucke B, Fieuws S, Van Pottelbergh G, Flamaing J, Van Den Noortgate N, Velghe A, De Cock AM, Gillain S, Meeuwissen J, Bautmans I, Beckwee D, de Saint-Hubert M, van Uffelen J, Schoevaerdts D, Tournoy J, van Achterberg T. Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge. Pilot Feasibility Stud. 2025 Jun 21;11(1):87. doi: 10.1186/s40814-025-01668-8. |
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IPD will be shared upon publication of the primary endpoint of the full trial, which will have a separate registration on clinicaltrial.gov.
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Patients are randomized 1:1 in one of the two intervention groups
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The study nurse, who assesses the outcomes during home visits (baseline, after six weeks, after one year) will be blinded
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| Standard of care | Other | Standard of care, without any restrictions. |
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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 |
| 1 year |
| 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 |
| 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 |
| 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 |
| 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 |
| Leuven |
| 3000 |
| Belgium |