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临床试验/NCT07049419
NCT07049419已完成不适用

The Impact of Environmental Controls on Mental Health

NHS Lothian2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年1月29日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
5
试验地点
2
主要终点
PROMIS Global10

研究概览

简要总结

Within the UK there are over 15 million people who live with at least one long term condition. Of these people, over 4 million suffer from mental health problems.

Environmental control systems are a type of assistive technology that can be controlled by a wide variety of different access methods (e.g. switches) and can assist people with physical disabilities usually with a neurological condition to control various electronic devices in the home environment. The systems are designed to provide independence, removing the requirement to be reliant on other people (for the operation of the controlled devices) and potentially could have a positive effect on mental health and quality of life.

The research question for this study is to determine impact of environmental controls on mental health. It is hypothesised that there will be a positive impact on mental health of the participants. The question above will be answered by collecting questionnaire data pre and post intervention. Participants will be identified by Clinical Scientists working in NHS Lothian's Environmental Control Service (ECS). Participants will be recruited from NHS Lothian and so will be living in the Lothian area. The patient will be contacted following the normal protocol for arranging an environmental control assessment, at which point they will be approached to join the study. Participants will answer questions in their home environment both in person and over the phone.

The end point of the study will be 14 months from the start date (allowing for follow up data to be collected for anyone recruited towards the end of the 12-month recruitment period.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for environmental control system (as per NHS Scotland criteria).
  • New user (no previous intervention).
  • Neurological condition.
  • Cognitive ability to answer the questions and to give consent.

排除标准

  • Previous environmental control intervention.
  • Patients requiring equipment not supplied by NHS Lothian's ECS (e.g. door interface).
  • Patient recently diagnosed (within 6 months).
  • Rapidly deteriorating condition.

结局指标

主要结局

PROMIS Global10

时间窗: From enrollment to the end of study period at 8 weeks post installation of the environmental control system.

A 10 question quality of life outcome measure which can be used to define two separate scores - one for physical health (the PROMIS Global Physical Health score) and one for mental health (the PROMIS Global Mental Health score).

PIADS

时间窗: From enrollment to the end of study period at 8 weeks post installation of the environmental control system.

The Psychosocial Impact of Assistive Devices scale (PIADS) was specifically developed for measuring the impact of assistive technology on a participant's psychological well-being, functional independence and quality of life.

次要结局

  • Study specific questionnaire(From enrollment to the end of study period at 8 weeks post installation of the environmental control system.)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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