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Trial registered on ANZCTR

Registration number

ACTRN12623000336684

Ethics application status

Approved

Date submitted

22/12/2022

Date registered

31/03/2023

Date last updated

13/04/2024

Date data sharing statement initially provided

31/03/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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)

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parkinson's Disease

Condition category

Condition code

Neurological

Parkinson's disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Comparator / control treatment

The control group will receive twelve weeks of usual intervention which normally consist of advice from treating medical officers and usual therapy program by rehabilitation professionals as necessary. The specifications of usual therapy such as type and frequency of the intervention will be at the discretion of their treating physician. This intervention is intended to be as undisturbed as possible and assumed to be the norm of administered PD treatments of the same sample. This group will be followed-up weekly via telephone, and given a self-reported logbook similar to the intervention group, but with edited parameters. The logbooks will be reviewed at the end of the trial. The usual program typically consists of physiotherapy (functional training, strength and balance training) and occupational therapy (activities of daily living training and self-care). Caregivers are not involved in the administration of these therapies, but may be included in any home-based practices prescribed by the attending physicians. Added additional activity for the control group may be given, such as educational leaflets.

Control group

Active

Outcomes

Primary outcome [1]

Changes in functional mobility of persons with parkinson's disease according to Timed Up and Go (TUG) test

Timepoint [1]

12 weeks post commencement of intervention

Primary outcome [2]

Changes in Motor Function of persons with Parkinson's Disease according to The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Timepoint [2]