Clinical trial NCT05774210: Cost of Parkinson's Disease in Hong Kong
Official title: Cost of Disease and Falls Among Individuals With Parkinson's Disease Living in Hong Kong:
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Keywords: Cost of illness
Falls
PD
Disease burden
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: The University of Hong Kong
First posted: 2023-03-17
Enrollment: 139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling patients with a confirmed diagnosis of Parkinson's disease who attend the outpatient clinics of the Prince Wales Hospital, Shatin and Queen Mary Hospital, Pok Fu Lam will be included in this study.

Brief 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.

Detailed 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Client Service Receipt Inventory - RAre disease (CSRI-Ra)
timeFrame: Change score after 6 months and 12 months
Secondary outcomes:
measure: Number of falls
timeFrame: Change score after 6 months and 12 months
measure: The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: Change score after 6 months and 12 months
measure: Hoehn and Yahr Scale
timeFrame: Change score after 6 months and 12 months
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Change score after 6 months and 12 months
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Change score after 6 months and 12 months
measure: Short-Form Health Survey (SF-36)
timeFrame: Change score after 6 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Stanley J Winser, PhD
role: PRINCIPAL_INVESTIGATOR
References: