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临床试验/NCT05094219
NCT05094219招募中不适用

Disease Burden of Parkinson's Disease in Hong Kong

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
Healthcare cost

研究概览

简要总结

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.

详细描述

Introduction Parkinson's disease is a complex neurodegenerative disorder resulting in a range of complications for both the individual and their families eventually leading to increased burden to the healthcare system.1 Reports from the year 2012 indicated 13,000 (0.186%) people in Hong Kong living with Parkinson's disease 2 and a recent global estimate in 2016 indicates 6.1 million people.3 Postural instability, freezing of gait and poor balance resulting in frequent falls are hallmarks of Parkinson's disease 4. Falls constitute the greatest health and injury risk related to people living with Parkinson's disease. 5, 6

The burden of falls:

Forty-six per cent of people with Parkinson's disease fall at least once every 3 months.7 A recent report suggests 35% to 90% of people with Parkinson's disease fall at least once after being diagnosed with the disease, with an average falls rate of 61%, with about 39% of these being recurrent.8 The sequelae of accidental falls are associated with a decrease in quality of life, increase in caregiver's burden, hip fractures, an increase in motor impairment, decreases in mobility and an increase in disease severity. It is therefore imperative to prevent falls in people with PD.

Falls prevention framework in Hong Kong:

The Elderly Health Service of the Department of Health, HKSAR has published the framework for falls prevention and management.12 The current framework for preventive care for older adults in Hong Kong emphasises fall prevention through physical exercise and pain management. Physical exercises for falls management often include balance training as well as improving muscle strength and mobility. However, these frameworks are for older adults in general. These recommendations have not been developed for individuals with Parkinson's disease, specifically, who both (a) are arguably at more risk of falls and related injuries, and (b) likely require special adaptations for common treatments, given their high rates of disability. Thus, there is a critical need for a similar framework for people with Parkinson's disease in Hong Kong. The proposed study is a necessary first step in the development of such a framework and would provide data that would inform such a framework for people with Parkinson's disease.

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
  • both genders
  • who are residing in Hong Kong.

排除标准

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

结局指标

主要结局

Healthcare cost

时间窗: Ongoing assessment from day 1 until 12 months

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.

次要结局

  • Number of falls(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))
  • Activities-specific Balance Confidence (ABC) scale(Day 1 (T1), 6 months (T2) and 12 months (T3))
  • Short-form Health survey (SF-36)(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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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