Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement

NCT05419284 | Completed

• 1 other identifier: S66154
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Stroke; Frailty

Keywords

geriatric patients; geriatric rehabilitation; physiotherapy; caregiver involvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care

  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

  up to 12 weeks

• Retention rate of participants

  1 year

• Number of falls during the +Care sessions

  up to 12 weeks

• Private physiotherapy after discharge

  6 weeks

Study Arms (3)

patient

EXPERIMENTAL

GAPP+Care

Other: GAPP+Care

caregiver

EXPERIMENTAL

+Care

Other: +Care

healthcare professional of the ward

OTHER

observation of GAPP+Care

Other: Observation of GAPP+Care

Interventions

GAPP+Care OTHER

standard physiotherapy 45 minutes per day, 5 day a week (GAPP) \+ 3 extra exercise sessions led by a caregiver (+Care)

patient

+Care 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

caregiver

Observation of GAPP+Care OTHER

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

healthcare professional of the ward

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• No available caregiver
• Unable to understand instructions
• Caregivers:
• 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.
• Physical unable to support the patient
• Unable to understand instructions
• Healthcare providers
• 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.

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Universitaire Ziekenhuizen Leuven, campus Pellenberg

Pellenberg, 3212, Belgium

Location

MeSH Terms

Conditions

Hip Fractures; Stroke; Frailty

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johan Flamaing, PhD, MD

  KU UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 15, 2022
• Study Start: March 28, 2022
• Primary Completion: March 27, 2023
• Study Completion: May 27, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

BE (1)