Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement
Primary Purpose
Hip Fractures, Stroke, Frailty
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
GAPP+Care
+Care
Observation of GAPP+Care
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring geriatric patients, geriatric rehabilitation, physiotherapy, caregiver involvement
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:
-
Sites / Locations
- Universitaire Ziekenhuizen Leuven, campus Pellenberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
patient
caregiver
healthcare professional of the ward
Arm Description
GAPP+Care
+Care
observation of GAPP+Care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care
Semi-structured interviews with patients, caregivers and healthcare providers
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
Retention rate of participants
Number of dropouts
Number of falls during the +Care sessions
number of falls noted in the exercise diary or mentioned during the interviews
Private physiotherapy after discharge
number of sessions per week
Use of the activity monitor MOX, Maastricht Instruments
measuring daily activity in minutes/24hours (sedentary - standing - dynamic)
Functional balance
Berg Balance Scale (BBS) 0-56, a higher score means a better outcome
Hand squeeze force
Maximum handgrip with dominant hand, measured with the Martin Vigory dynamometer, in kPa
Walking speed
4m walking test (4mWT), m/s
Quality of life patient and caregiver
Visual analog scale of quality of life (VAS QoL), 0-10 a higher score means a better outcome
Full Information
NCT ID
NCT05419284
First Posted
May 18, 2022
Last Updated
September 5, 2023
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05419284
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
May 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Stroke, Frailty
Keywords
geriatric patients, geriatric rehabilitation, physiotherapy, caregiver involvement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Experimental
Arm Description
GAPP+Care
Arm Title
caregiver
Arm Type
Experimental
Arm Description
+Care
Arm Title
healthcare professional of the ward
Arm Type
Other
Arm Description
observation of GAPP+Care
Intervention Type
Other
Intervention Name(s)
GAPP+Care
Intervention Description
standard physiotherapy 45 minutes per day, 5 day a week (GAPP)
+ 3 extra exercise sessions led by a caregiver (+Care)
Intervention Type
Other
Intervention Name(s)
+Care
Intervention Description
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
Intervention Name(s)
Observation of GAPP+Care
Intervention Description
Healthcare workers in the geriatric rehabilitation ward will be interviewed on their opinions on GAPP+Care
Primary Outcome Measure Information:
Title
Proportion of eligible individuals and their willingness to participate in GAPP+Care
Description
Number of available patients on the ward and number of eligible patients and caregivers and number of patients and caregivers who participate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Feasibility, appropriateness, and the hindering and facilitating factors of GAPP+Care
Description
Semi-structured interviews with patients, caregivers and healthcare providers
Time Frame
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)
Title
Fidelity to GAPP+Care
Description
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
Time Frame
up to 12 weeks
Title
Retention rate of participants
Description
Number of dropouts
Time Frame
1 year
Title
Number of falls during the +Care sessions
Description
number of falls noted in the exercise diary or mentioned during the interviews
Time Frame
up to 12 weeks
Title
Private physiotherapy after discharge
Description
number of sessions per week
Time Frame
6 weeks
Title
Use of the activity monitor MOX, Maastricht Instruments
Description
measuring daily activity in minutes/24hours (sedentary - standing - dynamic)
Time Frame
first week at baseline, first week after discharge (starting at day of discharge), and week 6 after discharge
Title
Functional balance
Description
Berg Balance Scale (BBS) 0-56, a higher score means a better outcome
Time Frame
3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
Title
Hand squeeze force
Description
Maximum handgrip with dominant hand, measured with the Martin Vigory dynamometer, in kPa
Time Frame
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
Title
Walking speed
Description
4m walking test (4mWT), m/s
Time Frame
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
Title
Quality of life patient and caregiver
Description
Visual analog scale of quality of life (VAS QoL), 0-10 a higher score means a better outcome
Time Frame
3 times over 10 weeks: baseline, at day of discharge (up tot 6 weeks after baseline) and at end of week 6 after discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Flamaing, PhD, MD
Organizational Affiliation
KU UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven, campus Pellenberg
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Feasibility of the Geriatric Activation Program Pellenberg With Caregiver Involvement
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