Parkinson DiseaseBurden of PDNCT05774210
Cost of Parkinson's Disease in Hong Kong
An observational study of Parkinson Disease, run by The Hong Kong Polytechnic University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Jul 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Community-dwelling participants with a confirmed diagnosis of Parkinson's disease Reside in Hong Kong
Who cannot join
- Patients who are bedridden or solely wheelchair users, Have atypical Parkinson's syndrome and Have other associated major illnesses, such as stroke.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cost of Disease and Falls Among Individuals With Parkinson's Disease Living in Hong Kong:
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.
Read the 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%.
- Conditions
- Parkinson Disease
- Keywords
- Cost of illness, Falls, PD, Disease burden
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change score after 6 months and 12 months
Secondary outcomes (6)
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
Measured: Change score after 6 months and 12 months
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.
Measured: Change score after 6 months and 12 months
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).
Measured: Change score after 6 months and 12 months
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
Measured: Change score after 6 months and 12 months
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
Measured: Change score after 6 months and 12 months
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.
Measured: Change score after 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Stanley J Winser, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774210
- Sponsor's protocol ID
- HMRF_SW_2023
- Acronym
- Burden of PD
- Status last verified
- Feb 2023
- First submitted
- 7 Mar 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost of Disease and Falls Among Individuals With Parkinson's Disease Living in Hong Kong:
- ClinicalTrials.gov ID
- NCT05774210
- Acronym / sponsor ID
- Burden of PD / HMRF_SW_2023
- Conditions
- Parkinson Disease
- Keywords
- Cost of illness, Falls, PD, Disease burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, The University of Hong Kong
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Community-dwelling participants with a confirmed diagnosis of Parkinson's disease Reside in Hong Kong
Key exclusion criteria (1 listed)
- Patients who are bedridden or solely wheelchair users, Have atypical Parkinson's syndrome and Have other associated major illnesses, such as stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Client Service Receipt Inventory - RAre disease (CSRI-Ra)
Time frame: Change score after 6 months and 12 months
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.
6 secondary outcomes
Number of falls
Time frame: Change score after 6 months and 12 months
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Change score after 6 months and 12 months
Hoehn and Yahr Scale
Time frame: Change score after 6 months and 12 months
Falls Efficacy Scale-International (FES-I)
Time frame: Change score after 6 months and 12 months
Activities-Specific Balance Confidence Scale (ABC)
Time frame: Change score after 6 months and 12 months
Short-Form Health Survey (SF-36)
Time frame: Change score after 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley J Winser, PhD principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanley J Winser, PhD (27666746 ext. 6746, stanley.j.winser@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Service Receipt Inventory - RAre disease (CSRI-Ra) (time frame: Change score after 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.