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临床试验/NCT05774210
NCT05774210尚未招募不适用

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

The Hong Kong Polytechnic University0 个研究点目标入组 139 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
139
主要终点
Client Service Receipt Inventory - RAre disease (CSRI-Ra)

研究概览

简要总结

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.

详细描述

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%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Client Service Receipt Inventory - RAre disease (CSRI-Ra)

时间窗: 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.

次要结局

  • Short-Form Health Survey (SF-36)(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)
  • Number of falls(Change score after 6 months and 12 months)
  • Activities-Specific Balance Confidence Scale (ABC)(Change score after 6 months and 12 months)
  • Falls Efficacy Scale-International (FES-I)(Change score after 6 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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