Disease Burden and Cost Consequence of Falls Among Individuals With Parkinson's Disease in Hong Kong: A Prospective Cost-utility Analysis

NCT05094219 | Recruiting

• 1 other identifier: HMRF_K-ZC5K
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: Estimate the cost of disease and falls among people with Parkinson's disease living in Hong Kong. Design: Prospective cost-utility analysis (base year 2021) with one baseline and two follow-up assessments at 6 months and 12 months Participants: Community-dwelling participants with Parkinson's disease of both genders of any age. Intervention: Nil Outcome measures: Self-reported questionnaires will be used to obtain information about the healthcare utility. In addition, the number of falls, the severity of Parkinson' disease assessed using the MDS-Unified Parkinson's Disease Rating Scale, level of disability using the Hoehn and Yahr scale, balance using the Mini Balance Evaluation Systems Test and Activities-specific Balance Confidence (ABC) scale, risk of falls using Falls Efficacy Scale International and quality of life using the Short-form Health survey (SF-36) will be assessed. Predictors of cost include fall frequency, balance status, disease severity, level of disability, quality of life, and duration of disease. Analysis: A multiple regression analysis will be conducted to determine which predictor (independent variable) influence the overall cost. The level of statistical significance (α) will be set at p\<0.05. A Tornado plot will be constructed for the individual items of both direct and indirect cost having the minimum and maximum range set at the 25th and 75th percentile. Two-way analysis of variance (ANOVA) will assess the differences in healthcare cost among frequent, in-frequent and non-fallers. Spearman's or Pearson correlation coefficient will assess correlations between quality of life and healthcare cost; disease severity and healthcare cost; falls frequency and healthcare cost. Benefits to healthcare and health Cost-estimation highlights information required to enhance the health care service for the target population. Through a similar study among patients with cerebellar ataxia, our team demonstrated specific challenges that need additional support from the policy-makers such as employment following disability, visits to specialists, home-care, and community participation for people with cerebellar ataxia in Hong Kong. This study will highlight the strength and weakness of the current healthcare system to people of Hong Kong with Parkinson's disease, this will inform the challenges for the healthcare requiring additional attention which in turn will have a beneficial impact on the future service.

Conditions

Parkinson Disease

Keywords

Falls; Cost; Disease burden; Economic evaluation

Outcome Measures

Primary Outcomes (1)

• Healthcare cost

  We will estimate both direct and indirect cost using the self-reported questionnaires available in both English and Chinese languages. The following criteria were used to choose the individual items under direct and indirect costs: relevance to Parkinson's disease, relevance to falls and consequences of falls, how quantifiable the items are, based on the commonly estimated items in similar economic, and to the extent to which the item reflects and impacts the quality of life of people with Parkinson's disease.

  Ongoing assessment from day 1 until 12 months

Secondary Outcomes (7)

• Number of falls

  Day 1 (T1), 6 months (T2) and 12 months (T3)

• MDS-UPDRS

  Day 1 (T1), 6 months (T2) and 12 months (T3)

• Hoehn and Yahr scale

  Day 1 (T1), 6 months (T2) and 12 months (T3)

• MiniBESTest

  Day 1 (T1), 6 months (T2) and 12 months (T3)

• Falls Efficacy Scale International (FES-I)

  Day 1 (T1), 6 months (T2) and 12 months (T3)

Study Arms (1)

Observation group

Patients with a confirmed diagnosis of Parkinson's disease will be followed up for 12 months from the date of enrollment.

Other: No intervention will be offered

Interventions

No intervention will be offered OTHER

No intervention will be offered

Observation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling participants with a confirmed diagnosis of Parkinson's disease of both genders of any age and who are residing in Hong Kong

You may qualify if:

• community-dwelling participants with a confirmed diagnosis of Parkinson's disease
• both genders
• any age
• who are residing in Hong Kong.

You may not qualify if:

• are wheelchair-bound or bed-ridden,
• have atypical Parkinson's syndrome and
• other associated major illness such as stroke.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Chinese University of Hong Kong: collaborator
• The University of Hong Kong: collaborator
• Parkinson's Disease Foundation: collaborator

Study Sites (2)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, 00, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Stanley J Winser, PhD

  The Hong Kong Polytechnic Universit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley J Winser, PhD

CONTACT

+85227666746; stanley.j.winser@polyu.edu.hk

Joe W Pun, BA

CONTACT

27666746; joe.wing.pun@polyu.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 26, 2021
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)