Cost of Parkinson's Disease in Hong Kong

Parkinson Disease Clinical Trial

— Burden of PD  

Official title:

Cost of Disease and Falls Among Individuals With Parkinson's Disease Living in Hong Kong:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05774210
• Other study ID #: HMRF_SW_2023
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2023
• Source: The Hong Kong Polytechnic University
• Contact: Stanley J Winser, PhD
• Phone: 27666746
• Email: stanley.j.winser[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this study is to estimate the cost of disease and falls among people with Parkinson's disease in Hong Kong . There will be no intervention delivered to the participants.

The healthcare cost of 12 months will be recorded using self-report and and the Hospital Authority Clinical Management System.

Description:

Objective: Estimate the cost of disease and falls among people with Parkinson's disease in Hong Kong.

Design: Prospective cost-of-illness analysis with one baseline assessment and two follow-up assessments after 6 and 12 months.

Participants: Community-dwelling participants with Parkinson's disease. Intervention: N/A. Outcome measures: Self-reported questionnaires and the Hospital Authority Clinical Management System will be used to inform the healthcare utilisation. We will also assess the number of falls, severity of Parkinson's disease, level of disability, balance, risk of falls, and quality of life. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life and disease duration.

Analysis: Cost-of-illness analysis will estimate the direct and indirect cost, using a prevalence-based approach, by converting physical units to monetary value based on unsubsidised charges for healthcare in Hong Kong published by the Hospital Authority for the year 2022. A multiple regression analysis will determine predictors influencing the overall cost. A two-way ANOVA will assess differences in healthcare costs among frequent, infrequent and non-fallers. Sensitivity analysis will include (1) tornado plots for studying the degree of impact of the cost variables on mean cost, (2) analysis after removing cost outliers and (3) varying the expenses on selected cost items by 25%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 139
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Community-dwelling participants with a confirmed diagnosis of Parkinson's disease Reside in Hong Kong

Exclusion Criteria:

Patients who are bedridden or solely wheelchair users, Have atypical Parkinson's syndrome and Have other associated major illnesses, such as stroke.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Chinese University of Hong Kong, The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client Service Receipt Inventory - RAre disease (CSRI-Ra)	The CSRI is a widely used measure for recording cost-related data. The measure covers five key sections including background information, household and carer support, healthcare service and resource utilization, community support and education and employment. The CSRI-Ra is cross-culturally validated for Hong Kong Population (reference added to appendix 3a). The Chinese version of the self-reported CSRI-Ra both the patient version and carers version will be used in this study. The cost data will be captured across 6 months retrospective period. The background section 1 will be completed during the baseline assessment (T1) and sections 2 onwards will be completed during T2 and repeated during T3 assessment timelines.	Change score after 6 months and 12 months
Secondary	Number of falls	We define a fall as any rapid and uncontrolled change from a sitting or upright position to a reclining position or the ground. Based on the number of falls, we define frequent fallers as those who have fallen five or more times, infrequent fallers as those with four or fewer falls, and non-fallers as those with no falls over 12 months	Change score after 6 months and 12 months
Secondary	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	MDS-UPDRS is a measure of Parkinson's disease severity. The scale is scored from 0 to 199, with 0 indicating no disability and 199 indicating maximal disability due to disease. Severity is scored across five segments, including (i) mental, behavior and mood, (ii) activities of daily living (ADL), (iii) motor examination, (iv) the modified Hoehn and Yahr Scale, and (v) the Schwab and England ADL scale.	Change score after 6 months and 12 months
Secondary	Hoehn and Yahr Scale	The Hoehn and Yahr Scale is a measure for the level of disability due to Parkinson's disease. The scale classifies the patient from Stage 0 (no disease signs) to Stage 5 (bedridden or solely mobile by wheelchair).	Change score after 6 months and 12 months
Secondary	Falls Efficacy Scale-International (FES-I)	The FES-I is a self-reported measure for assessing the fear of falls among community-dwelling older adults. The scale includes 16 items, scored between 1 and 4. The scale has a minimum score of 16, which indicates no concerns regarding falls, and a maximum score of 64, indicating maximal concern regarding falls. The FES-I is a valid measure for estimating the fall risk among people with Parkinson's disease	Change score after 6 months and 12 months
Secondary	Activities-Specific Balance Confidence Scale (ABC)	The ABC is a non-disease-specific, self-reported measure of balance confidence. The scale includes 16 items, each rated between 0%, indicating no confidence, and 100%, indicating complete confidence regarding the activity in question. Higher scores indicate better balance performance. The ABC is both reliable and valid for the assessment of balance in people with Parkinson's disease	Change score after 6 months and 12 months
Secondary	Short-Form Health Survey (SF-36)	Quality of life will be measured using the SF-36. The scale has eight domains, each scored between 0 and 100, with 0 interpreted as worst health and 100 as the best health status.	Change score after 6 months and 12 months