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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Control
Active Comparator
Treatment as usual
干预措施: Control group-treatment as usual (Other)
Intervention
Experimental
Will receive the Health Champion intervention
干预措施: Health Champions intervention (Other)
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
研究点 (1)
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