跳至主要内容
临床试验/NCT04124744
NCT04124744Unknown不适用

A Pilot Randomised Controlled Trial of a Volunteer Health Champion Intervention to Support People With Severe Mental Illness to Improve Their Physical Health

King's College London2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
EQ-5D-3L

研究概览

简要总结

This study is a pilot RCT to evaluate the effectiveness and implementation challenges of an intervention using volunteer 'Health Champions' matched with service users to support service their physical health goals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

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

  • Older than 18 years old with a serious mental illness (Mood [affective] disorders [F30-F39], Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders [F20-F29]).
  • Currently with a Community Mental Health Team (CMHT).
  • Want to make changes to their physical health.
  • Has capacity to give written informed consent to take part in the project.
  • Able to provide a named Care Coordinator or Point of Contact reachable in the event of a health crisis.

排除标准

  • • Under 18 years of age
  • Unable to give informed consent

结局指标

主要结局

EQ-5D-3L

时间窗: Change in outcome from baseline at 9 months and 15 months

Physical health related quality of life measure-The descriptive system element of the EQ-5D questionnaire produces a 5-digit health state profile that represents the level of reported problems on each of the five dimensions of health. A higher score indicates poorer health. into a single summary number.

次要结局

  • Multimorbidity Treatment Burden Questionnaire(Change in outcome from baseline at 9 months and 15 months)
  • Health screenings in last 6 months(change in number of health screenings from baseline at 9 months and 15 months)
  • Recovering Quality of Life Questionnaire-ReQOL(Change in outcome from baseline at 9 months and 15 months)
  • Patient Activation Measure(Change in outcome from baseline at 9 months and 15 months)
  • De Jong Gierveld Loneliness Scale(Change in outcome from baseline at 9 months and 15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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