Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Frailty; Hip Fractures
• Intervention / Treatment: Other: GAPP+Care; Other: +Care; Other: Observation of GAPP+Care

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaretha van Dijk, Msc; Phone Number: 0032332894; Email: margaretha.vandijk@uzleuven.be

Study Locations

• Belgium
  • Pellenberg, Belgium, 3212
    • Universitaire Ziekenhuizen Leuven, campus Pellenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient; GAPP+Care	Other: GAPP+Care; standard physiotherapy 45 minutes per day, 5 day a week (GAPP) + 3 extra exercise sessions led by a caregiver (+Care)
Experimental: caregiver; +Care	Other: +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
Other: healthcare professional of the ward; observation of GAPP+Care	Other: Observation of GAPP+Care; Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
Retention rate of participants	Number of dropouts	1 year
Number of falls during the +Care sessions	number of falls noted in the exercise diary or mentioned during the interviews	up to 12 weeks
Private physiotherapy after discharge	number of sessions per week	6 weeks
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
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
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
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
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Johan Flamaing, PhD, MD, KU UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): March 27, 2023
• Study Completion (Actual): May 27, 2023

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physiotherapy; geriatric patients; caregiver involvement; geriatric rehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Frailty; Hip Fractures
• Other Study ID Numbers: S66154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No