NCT05774210

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 17, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

March 7, 2023

Last Update Submit

March 7, 2023

Conditions

Keywords

Cost of illnessFallsPDDisease burden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Number of falls

    Change score after 6 months and 12 months

  • The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Change score after 6 months and 12 months

  • Hoehn and Yahr Scale

    Change score after 6 months and 12 months

  • Falls Efficacy Scale-International (FES-I)

    Change score after 6 months and 12 months

  • Activities-Specific Balance Confidence Scale (ABC)

    Change score after 6 months and 12 months

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Stanley J Winser, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley J Winser, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 17, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

March 17, 2023

Record last verified: 2023-02