Clinical trial NCT05419284: Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement
Official title: Feasibility of the Geriatric Activation Program Pellenberg With the Informal Caregiver as Exercise Partner of the Physiotherapist (GAPP+Care)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Stroke
Frailty
Keywords: geriatric patients
geriatric rehabilitation
physiotherapy
caregiver involvement
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-06-15
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study
Primary purpose: TREATMENT

Brief summary: This interventional study aims to see if involving caregivers as exercise partners with the physiotherapist throughout in-hospital geriatric rehabilitation and the first six weeks following discharge is feasible.

Caregivers will receive hands-on training from physiotherapists so that they can assist their family members with their exercises. The caregivers will provide 30-minute exercise sessions three times each week in addition to the standard physiotherapy.

The researchers want to know how many people are eligible for GAPP+CARE and how willing they are to participate. The researchers also want to know about the program's hindering and facilitating elements, as well as its fidelity and retention rate. Apart from that, the researchers want to examine if an effectiveness study and the used outcome measures are viable.

Detailed description: To meet the WHO guideline for daily exercise during and after hospitalization, physiotherapists must find ways for geriatric patients to be active outside of therapy time. Geriatric patients require assistance or supervision to exercise safely, yet physiotherapists and nurses are short on time. Instead, by providing carers with tools and instruction, the researchers might turn them into exercise partners for the physiotherapist.

The investigators designed an exercise program (GAPP+Care) customized to the caregiver's ability to exercise safely with their loved one, based on the ideas and exercises of our standard physiotherapy program, the Geriatric Activation Program Pellenberg (GAPP). Through semi-structured interviews, patients and their caregivers were involved in developing and validating GAPP+Care, including the exercise booklet.

GAPP+Care consists of GAPP (the usual physiotherapy treatment) and three additional 30-minute exercise sessions with the caregiver each week (+Care). +Care will continue at home for the first six weeks after discharge, and GAPP will be replaced with physiotherapy performed by a private physiotherapist, as described at discharge (a prescription for home physiotherapy 3 times a week, for 60 sessions F-pathology or 18 sessions).

The initial +Care session is with a ward physiotherapist who will show the caregiver how to utilize the GAPP+Care handbook and the exercises and teach them how to support the patient during the exercises. During hospitalization, one of the three weekly sessions will be led by a ward physiotherapist to reinforce the hands-on skills and knowledge. These physiotherapy-patient-caregiver sessions will consist of two home visits and four phone calls after the patient has been discharged.

The goal of this exploratory study is to see if GAPP+Care is feasible. The researchers want to know how many people are eligible and how willing they are to participate. The researchers also want to assess the program's hindering and facilitating elements, as well as its fidelity and retention rate. Aside from that, the researchers want to evaluate if an effectiveness study and the used outcome measures are viable.

Eligibility criteria: Patients:

Inclusion Criteria:

* Patients from geriatric rehabilitation unit, with various pathologies
* ≥ 70 years old
* ≥ 10m of walking with walking aid and under supervision
* Berg Balance Scale (BBS) \< 30/56
* Medically stable as determined by the attending physician
* Expecting at least 3 weeks of rehabilitation

Exclusion Criteria:

* No available caregiver
* Unable to understand instructions

Caregivers:

Inclusion Criteria:

* A person who is willing to support the patient in performing exercises at least 3 times a week for 30 minutes. An informal carer is defined as an unpaid member of a person's social network who helps the patient with activities of daily living.

Exclusion Criteria:

* Physical unable to support the patient
* Unable to understand instructions

Healthcare providers

Inclusion Criteria:

* Someone who works on our ward, comes into contact with patients and may experience GAPP+CARE or its effects; nurse, physiotherapist, occupational therapist, social worker, doctor, logistical worker.

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of eligible individuals and their willingness to participate in GAPP+Care
timeFrame: 1 year
Secondary outcomes:
measure: Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care
timeFrame: patients and caregivers 2 times (at day of discharge and at the end of week 6 after discharge), healthcare providers 1 time (in the last 6 months of the study)
measure: Fidelity to GAPP+Care
timeFrame: up to 12 weeks
measure: Retention rate of participants
timeFrame: 1 year
measure: Number of falls during the +Care sessions
timeFrame: up to 12 weeks
measure: Private physiotherapy after discharge
timeFrame: 6 weeks
measure: Use of the activity monitor MOX, Maastricht Instruments
timeFrame: first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge
measure: Functional balance
timeFrame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
measure: Hand squeeze force
timeFrame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at the end of week 6 after discharge
measure: Walking speed
timeFrame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at the end of week 6 after discharge
measure: Quality of life patient and caregiver
timeFrame: 3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: Universitaire Ziekenhuizen Leuven, campus Pellenberg
Study officials:
affiliation: KU UZ Leuven
name: Johan Flamaing, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: