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Effectiveness of a Structured, Multi-Component Training Module for Family Caregivers of Persons with Parkinson’s disease

A Single-Blind, Randomized, Controlled Trial Evaluating the Effectiveness of a Structured, Multi-Component Training Module for Family Caregivers of Persons with Parkinson’s disease (PD)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000336684
Enrollment
80
Registered
2023-03-31
Start date
2024-02-05
Completion date
2024-04-30
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Parkinson’s disease (PD), a neurodegenerative disorder that progresses over time, is steadily growing in number and prevalence in Malaysia, expected to increase fivefold from the current estimate by 2040. Treatment programs of PD in Malaysia are scarce, and there is no known comprehensive PD family training program available to date. This study aims to evaluate the clinical and cost-effectiveness of a structured, comprehensive training program of family to persons with PD. A total of 140 participants including PD patients of stage I and II and their caregivers will be recruited for 12 weeks, and allocated into either an experimental or a control group. The experimental group (n=70) will undergo initial training from a multi-disciplinary health care provider. The group will then be given a developed module containing weekly instructions that will be practiced at home. While the control group (n=70) will receive a usual intervention that consists of physiotherapy (functional training, strength and balance training) and occupational therapy (activities of daily living training and self-care). Both groups will be assessed in terms of physical functions, mobility, quality of life of patients and caregivers, level of caregiver burden, and caregiver knowledge at baseline and after 12 weeks of interventions. Throughout the commencement of the trial, the interventions’ cost will also be estimated using an Activity-based costing method and a cost-effectiveness analysis will be performed. All data will be analyzed using descriptive and inferential tests. It is expected that the PD family training program is effective as well as cost-effective. It is hoped that this study will reinforce the value of the PD family training program that has been developed.

Interventions

Name of Intervention: A Structured Multi-component Family Training Program for Persons with Parkinson’s Disease (PD) Description of Intervention: It is a 12-week home-based family training program for persons with Parkinson's Disease developed by a panel of 7 total experts of respective fields namely neurology, nursing, Occupational Therapy, Physiotherapy, Speech and Language Pathology, Psychology and Dietetics. A training module booklet containing multi-component training materials will be pro

Name of Intervention: A Structured Multi-component Family Training Program for Persons with Parkinson’s Disease (PD) Description of Intervention: It is a 12-week home-based family training program for persons with Parkinson's Disease developed by a panel of 7 total experts of respective fields namely neurology, nursing, Occupational Therapy, Physiotherapy, Speech and Language Pathology, Psychology and Dietetics. A training module booklet containing multi-component training materials will be provided to facilitate care at home. The contents of the module consist of multi-care physical exercises (eg: cardio, mobility, strengthening, balance, posture, breathing, functional daily activities, transfer and positioning) and psychosocial tasks (eg: relaxation exercises, mindfulness, speech training, and dietary routines), as well as guidance on healthcare for persons with Parkinson's Disease. In this module, caregivers will be given guidance to supervise persons with Parkinson's to perform the tasks contained in the module. Tasks are to be done 1-3 times per week (for 12 weeks), or as advised specifically by their attending neurologists. Each task may take anywhere between 10-30 minutes, depending on the tolerance of the patients. The module was designed specifically for this study as a guide for caregivers in managing the condition of Parkinson's Disease. While some tasks can be done independently by the patients themselves, all tasks are intended to be done with the supervision (and assistance as required) by their respective caregivers. Completion of tasks will be recorded by the patients and caregivers in logbooks containing the tasks assigned and their respective frequencies. At the end of the 12-week intervention, the logbooks will be referred to in order to determine the patients' compliance to the program. Weekly follow-ups with participants and caregivers will be conducted by researchers via telephone calls. The module guidelines and tasks will be established in a two-day training session, with three hours per day, conducted by a group of multidisciplinary health care professionals, respective to their fields in the module (eg: Neurologists for medical section, nursing for daily care, physiotherapists for physical exercises, occupational therapists for functional activities of daily living, speech therapists for speech and communication, dietician for dietary requirements, psychologists for psychosocial tasks). The mode of delivery for the training session will be by group, and each group will have a trainer to caregiver ratio of 1:4 (1 trainer to 4 caregivers). Only the caregivers are required to be present for the training sessions, but patients are also encouraged to join. The training will be administered face-to-face in the Physiotherapy Department of the Faculty of Allied Health Science in the National University of Malaysia (UKM) Kuala Lumpur Campus. The training sessions will be repeated accordingly until all participants have been trained sufficiently. The training session will commence 2 weeks before starting the 12-week intervention. After each session, participants will be tested with a reliability test to determine whether their understanding is satisfactory enough to carry out the 12-week intervention.

Sponsors

National University of Malaysia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

(A) Persons with PD 1. Age 18-75 years old 2. Stage I and II of Parkinson’s disease based on Hoehn & Yahr (HY) scale 3. Availability of family caregivers. (B) Family caregivers 1. Main caregiver who lives with the PD patient

Exclusion criteria

(A) Persons with PD 1. Impaired physical function due to other conditions such as a recent fracture within the past 6 months, severe arthritis or other neurological disease such as peripheral neuropathy. 2. Have medical illness limiting participation in exercise, such as unstable angina and uncontrolled hypertension. (B) Family caregiver: 1. Providing part-time caregiving due to availability of maid/helper 2. Presence of clinically diagnosed depression with a score of 16 or greater according to the Center for Epidemiological Studies-Depression (CES-D) scale as measured by therapist during screening. 3. Presence of mild cognitive impairment or dementia with a point of less than 26 according to the Montreal Cognitive Assessment (MoCA) as measured by therapist during screening.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026