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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] 308198 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 327988 0
Condition category
Condition code
Neurological 325048 325048 0 0
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] 324689 0
Rehabilitation
Intervention code [2] 325428 0
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] 332870 0
Changes in functional mobility of persons with parkinson's disease according to Timed Up and Go (TUG) test
Timepoint [1] 332870 0
12 weeks post commencement of intervention
Primary outcome [2] 332871 0
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] 332871 0
12 weeks post commencement of interventions
Secondary outcome [1] 414908 0
Changes in the knowledge levels of caregivers of persons with Parkinson's Disease according to the Knowledge of PD Questionnaire (KPDQ)
Timepoint [1] 414908 0
12 weeks post commencement of interventions
Secondary outcome [2] 414909 0
Changes in the level of caregiving burden based on the Zarit Burden Interview
Timepoint [2] 414909 0
12 weeks post commencement of interventions
Secondary outcome [3] 414910 0
Differences of cost-effectiveness between the interventions by calculating incremental cost-effectiveness ratio (ICER) using Activity-Based Costing (ABC) method through a self-administered economic burden questionnaire for estimation of costs for each intervention. A method of assigning overhead and indirect costs, such as salaries and utilities, to products and services. The cost driver rate, which is the cost pool total divided by cost driver, is used to calculate the amount of overhead and indirect costs related to a particular activity.
Cost will be from the perspectives of the patient, family caregivers, and healthcare providers. Data on direct costs (e.g., cost of equipment/medication/treatment, human resource, transportation, module purchase, administration, maintenance, clinic utilities, consumables, and other expenses) and indirect costs (e.g., loss of income/productivity) of the two interventions will be gathered.
Timepoint [3] 414910 0
12 weeks post commencement of interventions
Secondary outcome [4] 417094 0
Feasibility assessment according to a self-administered report by the participants using a study-specific questionnaire of a 5-point Likert scale (accounted by both the person with PD and their caregivers), including drop outs.

The feasibility assessment is a composite that includes the assessment components of presence of adverse events, retention of effect, compliance, adherence, time practicability, training viability, and dropout rate.

Examples of known adverse effects include new soreness and incidences of falls during intervention phase, assessed with a study-specific questionnaire.
Timepoint [4] 417094 0
12 weeks post commencement of interventions
Secondary outcome [5] 418466 0
Changes in Non-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 [5] 418466 0
12 weeks post commencement of interventions
Secondary outcome [6] 418467 0
Changes in Quality of Life of persons with parkinson's disease according to EuroQol-5 Dimension questionnaire rating
Timepoint [6] 418467 0
12 weeks post commencement of interventions
Secondary outcome [7] 418468 0
Changes in Quality of Life of caregivers of persons with parkinson's disease according to EuroQol-5 Dimension questionnaire rating
Timepoint [7] 418468 0
12 weeks post commencement of interventions
Secondary outcome [8] 418469 0
Acceptance of the training program according to an assessment using self-administered report by the participants (accounted by both the person with PD and their caregivers), including drop outs
Timepoint [8] 418469 0
12 weeks post commencement of interventions

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes administered by a health personnel blinded to the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To compare the pre and post score of functions, mobility and quality of life (QOL) between persons with Parkinson's Disease (PD) receiving the structured multi-component family caregiver-training program and control group using 6x2 Mixed Model ANOVA

To compare the pre and post score knowledge, QOL and burden between family members of persons with PD receiving the structured multi-component family caregiver-training program and control group using 6x2 Mixed Model ANOVA.

To determine the cost effectiveness and sustainability of the structured multi-component family caregiver-training program among the family of persons with PD using Incremental Cost-Effectiveness Ratio (ICER) calculation, descriptive statistics (Mean, standard deviation and percentage) according to retention of effect, compliance, adherence and number of drop outs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
5/02/2024
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
120
Accrual to date
80
Final
Recruitment outside Australia
Country [1] 25072 0
Malaysia
State/province [1] 25072 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 312455 0
University
Name [1] 312455 0
National University of Malaysia
Country [1] 312455 0
Malaysia
Primary sponsor type
University
Name
National University of Malaysia
Address
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 314915 0
None
Name [1] 314915 0
Address [1] 314915 0
Country [1] 314915 0
Other collaborator category [1] 282512 0
Charities/Societies/Foundations
Name [1] 282512 0
Malaysian Parkinson's Disease Association
Address [1] 282512 0
35, Jalan Nyaman 10, Taman Bukit Indah, 58200 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country [1] 282512 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311799 0
Research Ethics Committee Universiti Kebangsaan Malaysia (RECUKM)
Ethics committee address [1] 311799 0
Secretariat of Research and Innovation

Faculty of Medicine UKM
2nd Floor, Educational Block
Jalan Yaacob Latif, Bandar Tun Razak
56000 Cheras, Wilayah Persekutuan Kuala Lumpur.
Ethics committee country [1] 311799 0
Malaysia
Date submitted for ethics approval [1] 311799 0
01/04/2022
Approval date [1] 311799 0
01/07/2022
Ethics approval number [1] 311799 0
UKM PP/111/8/JEP-2022-302

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122410 0
A/Prof Nor Azlin Mohd Nordin
Address 122410 0
Physiotherapy Program
Centre for Rehabilitation and Special Needs (iCaRehab),
Faculty of Health Sciences (FSK)
Universiti Kebangsaan Malaysia (UKM)
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122410 0
Malaysia
Phone 122410 0
+60193594418
Fax 122410 0
Email 122410 0
norazlin8@ukm.edu.my
Contact person for public queries
Name 122411 0
Mrs Sharmila a/p Gopala Krishna Pillai
Address 122411 0
Physiotherapy Program
Centre for Rehabilitation and Special Needs (iCaRehab),
Faculty of Health Sciences (FSK)
Universiti Kebangsaan Malaysia (UKM)
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122411 0
Malaysia
Phone 122411 0
+60102486045
Fax 122411 0
Email 122411 0
sharmilapillai89@gmail.com
Contact person for scientific queries
Name 122412 0
Mrs Sharmila a/p Gopala Krishna Pillai
Address 122412 0
Physiotherapy Program
Centre for Rehabilitation and Special Needs (iCaRehab),
Faculty of Health Sciences (FSK)
Universiti Kebangsaan Malaysia (UKM)
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 122412 0
Malaysia
Phone 122412 0
+60102486045
Fax 122412 0
Email 122412 0
sharmilapillai89@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.