RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
研究概览
简要总结
The purpose of this study is to determine whether community-based rehabilitation plus facility-based care is superior to facility-based care alone in reducing disability related to schizophrenia in rural Ethiopia.
详细描述
This is a cluster randomised trial set in rural Ethiopia with kebeles (villages) as the unit of randomisation. 54 kebeles will be included. 27 will be randomly allocated to the intervention arm (Facility based care (FBC) + Community-based Rehabilitation (CBR)) and 27 randomly allocated to the control arm (FBC alone).
The aim is to determine whether CBR + FBC is superior to FBC alone in reducing disability related to schizophrenia, measured by the WHO Disability Assessment Schedule version 2.0 (WHODAS 2.0) at 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •Age ≥18 years
- •Diagnosis of schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using (DSM-IV) criteria
- •Evidence of severe, enduring or disabling illness
- •Resident in kebele for >6 months and no immediate plans to leave the kebele
- •Has a primary caregiver who is willing to participate in the study
排除标准
- •No specific criteria
研究组 & 干预措施
Community-based rehabilitation and facility based care
Community-based rehabilitation is delivered to participants and their caregivers at their home by a specialist CBR worker. It comprises psychoeducation, adherence support, rehabilitation (including self-care and social skills), family support groups and accessing existing community organisations. It also involves community awareness raising and education and mobilisation of community leaders.
Facility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
干预措施: Community-based rehabilitation (Behavioral)
Community-based rehabilitation and facility based care
Community-based rehabilitation is delivered to participants and their caregivers at their home by a specialist CBR worker. It comprises psychoeducation, adherence support, rehabilitation (including self-care and social skills), family support groups and accessing existing community organisations. It also involves community awareness raising and education and mobilisation of community leaders.
Facility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
干预措施: Facility based care (Other)
Facility-based care
Facility based care (usual care) consists of anti-psychotic medication prescribed by a nurse or clinical officer in a health centre and basic psycho-education.
干预措施: Facility based care (Other)
结局指标
主要结局
Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
时间窗: 12 months
次要结局
- Engagement with facility based care(6 and 12 months)
- Disability (36-item WHODAS 2.0)(6 months)
- Functioning (indigenous functioning scale)(6 and 12 months)
- Medication adherence (4 item Morisky Medication Adherence Scale)(6 and 12 months)
- Serious adverse events(6 and 12 months)
- Economic activity of caregiver(6 and 12 months)
- Caregiver depression (PHQ9 +1)(6 and 12 months)
- Economic activity of patient (employment, income and household work)(6 and 12 months)
- Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))(6 and 12 months)
- Clinical Global Impression (CGI)(6 and 12 months)
- Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))(6 and 12 months)
- Proportion with human rights problems (chaining or restraint)- Caregiver-reported(6 and 12 months)
- Proportion with human rights problems (chaining or restraint)- self-reported(6 and 12 months)
- Nutritional status (BMI)(6 and 12 months)
- Caregiver burden (WHO Family Interview Schedule Impact section)(6 and 12 months)
- Patient medication adherence(6 and 12 months)