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临床试验/NCT03275649
NCT03275649已完成不适用

Development of an Intervention to Increase Help-seeking for Non-motor Symptoms in People With Parkinson's

City, University of London1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2017年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Proportion of patients help-seeking post-intervention

研究概览

简要总结

Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant distress and decreased quality of life. A high rate of non-declaration of NMS by patients means that many NMS remain unrecognized and untreated, even in specialist clinical services. In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical Domains Framework and used to identify the barriers for help-seeking. A quantitative questionnaire survey (phase 2) examined the significance of these barriers to help seeking. The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted behavioural intervention of barriers which were identified in phases 1 and 2 which prevent help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will include people with unreported burdensome NMS, who have not reported them to their PD consultant or nurse. The intervention has been co-designed by people affected by Parkinson's and targets the barriers identified in the previous phases of the research. In phase three of the research, 'think-aloud' interviews will be used to further develop the intervention so that it is acceptable and easy to use. In the final phase, a feasibility trial will be conducted to examine efficacy of the intervention for increasing help-seeking for undeclared NMS. The study has implications for using a theoretically driven behavioural intervention to promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among patients with PD.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of idiopathic Parkinson's
  • •Access to a computer and internet connection
  • •Experiencing at least one unreported non-motor symptom

排除标准

  • •Presence of sensory loss or communication difficulty (including inadequate command of English) sufficient to interfere with the assessments.
  • •Severe cognitive impairment that would make participation in the intervention problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993). People with a score of less than 20 will be excluded.

结局指标

主要结局

Proportion of patients help-seeking post-intervention

时间窗: 1 week

after intervention

次要结局

  • Number of eligible patients completing the study(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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