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临床试验/NCT03111472
NCT03111472Unknown不适用

Development and Evaluation of a Self-management Guide for Community-dwelling People With Parkinson's Disease Who Fall and Their Informal Caregivers

University of Southampton2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Feasibility and acceptability of the guide

研究概览

简要总结

This study will investigate whether it is possible, through the development and evaluation of a self-management guide, to improve health related quality of life and concern of falling in people with Parkinson's disease who fall, and reduce caregiver burden in their informal caregivers.

详细描述

This study will progress through four phases

Phase One

Establish the needs and preferences of people with Parkinson's (PwP) who fall and their informal caregivers for the effective self-management of falls. This will be achieved through questionnaires distributed to 30-40 PwP and their caregivers, with responses analysed through the use of descriptive statistics. A purposive sample of participants, selected through responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will be conducted until data saturation has been achieved. These interviews will seek to further identify the thoughts and experiences of PwP and their caregivers in relation to falling, with responses analysed through thematic analysis.

Phase Two

Establish the needs and preferences of PwP who fall and their informal caregivers for the effective self-management of falls, as perceived by healthcare professionals specialising in the care of PwP. This will be achieved through semi-structured interviews and focus groups with 10 healthcare professionals involved in the care of PwP who fall. The interviews will be analysed with thematic analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of idiopathic Parkinson's disease, with or without cognitive impairment
  • People with Parkinson's living in their own home
  • At least one fall in the preceding year, as reported by the person with Parkinson's or the caregiver
  • Able to read a newspaper without severe difficulty, with or without glasses
  • An informal caregiver of a person with Parkinson's meeting the criteria for inclusion in the study

排除标准

  • Diagnosis of a Parkinson's Plus syndrome
  • People with Parkinson's living in a residential or nursing home
  • No falls in the preceding year
  • Non-fluent in verbal and written English

研究组 & 干预措施

Self-management guide for falls in Parkinson's

Experimental

A guide for people with Parkinson's and their caregivers to self-manage falls.

干预措施: Self-management guide for people with Parkinson's who fall and their informal caregivers (Other)

结局指标

主要结局

Feasibility and acceptability of the guide

时间窗: 3 months

This will assessed through response to a questionnaire, with responses analysed through descriptive statistics

次要结局

  • Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version(3 months)
  • Health related quality of life of people with Parkinson's as measured on PDQ8(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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