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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: 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 ord CONDITION: Neurological ‐ Parkinson's disease Parkinson's Disease; ; Parkinson's Disease PRIMARY OUTCOME: Changes in functional mobility of persons with parkinson's disease according to Timed Up and Go (TUG) test[12 weeks post commencement of intervention] 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) [12 weeks post commencement of interventions] 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 SECONDARY OUTCOME: 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[12 weeks post commencement of interventions] 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) [12 weeks post commencement of interventions] Changes in Quality of Life of caregivers of persons with parkinson's disease according to EuroQol‐5 Dimension questionnaire rating[12 weeks post commencement of interventions] Changes in Quality of Life of persons with parkinson's disease according to EuroQol‐5 Dimension questionnaire rating[12 weeks post commencement of interventions] Changes in the knowledge levels of caregivers of persons with Parkinson's Disease according to the Knowledge of PD Questionnaire (KPDQ) [12 weeks post commencement of interventions] Changes in the level of caregiving burden based on the Zarit Burden Interview[12 weeks post commencement of interventions] 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. ; [12 weeks post commencement of interventions] 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.[12 weeks post commencement of interventions ; ]
Epistemonikos ID: 3dcd10fec4f6ddf61abec9599477ff5666b904ec
First added on: Feb 20, 2024