The Potential Efficacy and Acceptability of the Chinese Health Improvement Profile (CHIP) in Improving the Physical Health of People With Severe Mental Illness - A Pilot Clustered Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 主要终点
- Self-reported physical well being
研究概览
简要总结
The investigators programme of research will evaluate an existing physical health care screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve the physical health wellbeing of people with a SMI.
This pilot clustered randomised controlled trial aims to establish the potential efficacy and acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical health of people with severe mental illness.
详细描述
This pilot study will use a non-blinded parallel group clustered randomised controlled trial design.
The study will be carried out by CPNs with community-dwelling people aged 18-65 who have a psychiatric diagnosis of SMI (i.e. schizophrenia, schizoaffective disorder, other psychotic disorder or bipolar affective disorder) and at the point of recruitment are being treated in the community. It will investigate the potential clinical impact of the use of the CHIP tool when used by CPNs with this patient group. Because the CHIP is designed to be used as both an enhanced physical health risk screening tool and as an instrument to direct appropriate clinical interventions the investigators will ask the patients' allocated CPNs to recruit consenting patients , collect outcome measure data and where appropriate use the CHIP tool with patients that they work with within their routine clinical practice.
Primary objective:
To test the potential efficacy and acceptability of the CHIP intervention compared to treatment as usual on patients' physical well- being over a 12 month period.
Secondary objectives:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those psychiatric outpatients under the care of the community psychiatric nursing service who are:
- •Aged 18-65 years;
- •Having a case-note diagnosis (as confirmed by a registered clinician) within the illness group entitled "severe mental illness" (SMI) containing schizophrenia, schizoaffective disorder, other psychotic disorders, depressive or bipolar affective disorder (type 1 or 2); and
- •Able to speak Chinese/English
- •Able to provide written informed consent and considered safe and competent to participate in the study (as suggested by attending psychiatrist).
排除标准
- •Co-morbidity of learning disability or organic brain diseases.
结局指标
主要结局
Self-reported physical well being
时间窗: 12 months after intervention
The primary outcome will be measured using the widely used and well-established Chinese version of the physical and mental health measure (SF12v2-PCS-12 subscale).
次要结局
- Satisfaction with services(12 months after intervention)
- Self-reported mental health(12 months after intervention)
研究者
Wai-Tong Chien
Professor and Associate Head (Research)
The Hong Kong Polytechnic University