Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement

NCT ID: NCT05419284

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2023-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures Stroke Frailty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Feasibility study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient

GAPP+Care

Group Type EXPERIMENTAL

GAPP+Care

Intervention Type OTHER

standard physiotherapy 45 minutes per day, 5 day a week (GAPP)

\+ 3 extra exercise sessions led by a caregiver (+Care)

caregiver

+Care

Group Type EXPERIMENTAL

+Care

Intervention Type OTHER

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

healthcare professional of the ward

observation of GAPP+Care

Group Type OTHER

Observation of GAPP+Care

Intervention Type OTHER

Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GAPP+Care

standard physiotherapy 45 minutes per day, 5 day a week (GAPP)

\+ 3 extra exercise sessions led by a caregiver (+Care)

Intervention Type 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

Intervention Type OTHER

Observation of GAPP+Care

Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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


* 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.


* 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

* No available caregiver
* Unable to understand instructions

Caregivers:


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

Healthcare providers


\-
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaretha van Dijk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan Flamaing, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

KU UZ Leuven

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitaire Ziekenhuizen Leuven, campus Pellenberg

Pellenberg, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S66154

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Physiotherapy/hypnosis for AVC Patients
NCT06885294 ENROLLING_BY_INVITATION NA