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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Disability Physical
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Feasibility of recruitment - screening
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Feasibility of recruitment - screening
Time Frame: 1 year
The number of potential participants screened/not screened for inclusion.
Feasibility of recruitment - retainment
Time Frame: 1 year
The number of (potential) participants recruited/not recruited, randomised and retained (frequency and proportion of participants that are randomized and completed 6w follow up).
Feasibility of study procedures, assessments and data collection
Time Frame: 1 year
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.
Feasibility of recruitment - reasons for non-participation
Time Frame: 1 year
Potential participants' reasons for refusing to participate (qualitative), expressed in frequency per reason for declining participation.
Study participants' experience with the intervention
Time Frame: 1 year
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.
Physical therapists' experience with the intervention
Time Frame: 1 year
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.
Secondary Outcomes
- The profiles of study participants(1 year)
- Time spent on study procedures and assessments(1 year)
- The study burden for participants (older persons)(6 weeks)
- The study burden for healthcare professionals(1 year)
- Physical therapists' experiences with the training protocol(1 year)
- Blinding of outcome assessors(1 year)