Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement

Stroke Clinical Trial

Official title:

Feasibility of the Geriatric Activation Program Pellenberg With the Informal Caregiver as Exercise Partner of the Physiotherapist (GAPP+Care)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05419284
• Other study ID #: S66154
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: May 27, 2023

Study information

• Verified date: September 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Frailty
• Hip Fractures
• Stroke

Intervention

Other:
• GAPP+Care
standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 3 extra exercise sessions led by a caregiver (+Care)
• +Care
3 extra exercise moments led by a caregiver: one physiotherapist-caregiver-patient exercise session: the physiotherapist will educate and train the caregiver on the exercises and hands-on skills. Two caregiver-patient exercise sessions
• Observation of GAPP+Care
Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven, campus Pellenberg	Pellenberg

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible individuals and their willingness to participate in GAPP+Care	Number of available patients on the ward and number of eligible patients and caregivers and number of patients and caregivers who participate	1 year
Secondary	Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care	Semi-structured interviews with patients, caregivers and healthcare providers	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)
Secondary	Fidelity to GAPP+Care	Number of exercise moments with physiotherapist; Noted in exercise diary Number of exercise moments with caregiver; Exercise Diary Number and kind of exercises with caregiver; Exercise Diary	up to 12 weeks
Secondary	Retention rate of participants	Number of dropouts	1 year
Secondary	Number of falls during the +Care sessions	number of falls noted in the exercise diary or mentioned during the interviews	up to 12 weeks
Secondary	Private physiotherapy after discharge	number of sessions per week	6 weeks
Secondary	Use of the activity monitor MOX, Maastricht Instruments	measuring daily activity in minutes/24hours (sedentary - standing - dynamic)	first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge
Secondary	Functional balance	Berg Balance Scale (BBS) 0-56, a higher score means a better outcome	3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Secondary	Hand squeeze force	Maximum handgrip with dominant hand, measured with the Martin Vigory dynamometer, in kPa	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
Secondary	Walking speed	4m walking test (4mWT), m/s	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
Secondary	Quality of life patient and caregiver	Visual analog scale of quality of life (VAS QoL), 0-10 a higher score means a better outcome	3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge