Williams Julie, Fairbairn Elliann, McGrath Ray, Bakolis Ioannis, Healey Andy, Akpan Ubong, Mdudu Isabel, Gaughran Fiona, Sadler Euan, Khadjesari Zarnie, Lillywhite Kate, Sevdalis Nick
Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
South London and Maudsley NHS Foundation Trust, London, UK.
Pilot Feasibility Stud. 2021 May 31;7(1):116. doi: 10.1186/s40814-021-00854-8.
People with serious mental illnesses (SMI) such as schizophrenia often also have physical health illnesses and interventions are needed to address the resultant multimorbidity and reduced life expectancy. Research has shown that volunteers can support people with SMI. This protocol describes a feasibility randomised controlled trial (RCT) of a novel intervention involving volunteer 'Health Champions' supporting people with SMI to manage and improve their physical health.
This is a feasibility hybrid II randomised effectiveness-implementation controlled trial. The intervention involves training volunteers to be 'Health Champions' to support individual people with SMI using mental health services. This face-to-face or remote support will take place weekly and last for up to 9 months following initial introduction. This study will recruit 120 participants to compare Health Champions to treatment as usual for people with SMI using secondary community mental health services in South London, UK. We will measure the clinical and cost effectiveness including quality of life. We will measure the implementation outcomes of acceptability, feasibility, appropriateness, fidelity, barriers and enablers, unintended consequences, adoption and sustainability.
There is a need for interventions to support people with SMI with their physical health. If this feasibility trial is successful, a definitive trial will follow to fully evaluate the clinical, cost and implementation effectiveness of Health Champions supporting people with SMI.
ClinicalTrials.gov, registration no: NCT04124744 .
患有精神分裂症等严重精神疾病（SMI）的人通常也患有身体健康疾病，需要采取干预措施来解决由此产生的多种疾病并存问题以及预期寿命缩短的问题。研究表明，志愿者可以为患有严重精神疾病的人提供支持。本方案描述了一项可行性随机对照试验（RCT），该试验涉及一种新型干预措施，即由志愿者“健康倡导者”支持患有严重精神疾病的人管理和改善他们的身体健康。
这是一项可行性混合II随机有效性-实施对照试验。干预措施包括培训志愿者成为“健康倡导者”，以支持使用心理健康服务的患有严重精神疾病的个体。这种面对面或远程支持将每周进行一次，在初次介绍后持续长达9个月。本研究将招募120名参与者，将健康倡导者与英国伦敦南部使用二级社区心理健康服务的患有严重精神疾病的人的常规治疗进行比较。我们将测量临床和成本效益，包括生活质量。我们将测量可接受性、可行性、适宜性、保真度、障碍和促进因素、意外后果、采用率和可持续性等实施结果。
需要采取干预措施来支持患有严重精神疾病的人的身体健康。如果这项可行性试验成功，随后将进行一项确定性试验，以全面评估健康倡导者支持患有严重精神疾病的人的临床、成本和实施效果。
ClinicalTrials.gov，注册号：NCT04124744 。
