RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) (RISE)
2017年5月9日 更新者：London School of Hygiene and Tropical Medicine
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
166
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Addis Ababa、埃塞俄比亚
- Department of Psychiatry, College of Health Sciences, Addis Ababa University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- No specific criteria
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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. |
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有源比较器：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
大体时间：12 months
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))
大体时间：6 and 12 months
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6 and 12 months
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Clinical Global Impression (CGI)
大体时间：6 and 12 months
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6 and 12 months
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Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))
大体时间：6 and 12 months
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6 and 12 months
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Disability (36-item WHODAS 2.0)
大体时间：6 months
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6 months
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Functioning (indigenous functioning scale)
大体时间：6 and 12 months
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Scale is currently under development.
It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.
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6 and 12 months
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Economic activity of patient (employment, income and household work)
大体时间：6 and 12 months
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Section includes current occupation (categories), employment status (categories), typical income (specific amount).
Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work task both generally and as a result of their mental illness (likert scale)
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6 and 12 months
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Medication adherence (4 item Morisky Medication Adherence Scale)
大体时间：6 and 12 months
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6 and 12 months
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Engagement with facility based care
大体时间：6 and 12 months
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Potential mediator
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6 and 12 months
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Proportion with human rights problems (chaining or restraint)- self-reported
大体时间：6 and 12 months
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The outcome is the proportion chained, restrained or confined within last one month.
Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected.
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6 and 12 months
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Nutritional status (BMI)
大体时间：6 and 12 months
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6 and 12 months
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Serious adverse events
大体时间：6 and 12 months
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6 and 12 months
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Economic activity of caregiver
大体时间：6 and 12 months
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Section includes current occupation (categories), employment status (categories), typical income (specific amount).
Section also includes questions adapted from the WHO-DAS 12 and 36 relating to problems doing usual work tasks (likert scale).
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6 and 12 months
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Caregiver burden (WHO Family Interview Schedule Impact section)
大体时间：6 and 12 months
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6 and 12 months
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Caregiver depression (PHQ9 +1)
大体时间：6 and 12 months
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6 and 12 months
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Patient medication adherence
大体时间：6 and 12 months
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6 and 12 months
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Proportion with human rights problems (chaining or restraint)- Caregiver-reported
大体时间：6 and 12 months
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Caregiver to report presence of human rights problems relating to patient.
The outcome is the proportion chained, restrained or confined within last one month.
Additional data on who perpetrated the chaining i.e. traditional healer/ family member will be collected.
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6 and 12 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Discrimination (DISC-12)
大体时间：6 and 12 months
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Potential mediator
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6 and 12 months
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Health service use and costs
大体时间：6 and 12 months
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Potential mediator
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6 and 12 months
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Depression (PHQ-9+1)
大体时间：6 and 12 months
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Potential confounder
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6 and 12 months
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Access/ adherence to CBR and reasons for non-adherence
大体时间：6 and 12 months
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Potential mediator
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6 and 12 months
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Social support (OSLO-3)
大体时间：6 and 12 months
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Potential mediator
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6 and 12 months
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Stigma and discrimination (WHO Family Interview Schedule Stigma section)
大体时间：6 and 12 months
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6 and 12 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mary De Silva, PhD MSc、London School of Hygiene and Tropical Medicine
- 首席研究员：Abebaw Fekadu、Addis Ababa University Department of Psychiatry
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Asher L, Birhane R, Weiss HA, Medhin G, Selamu M, Patel V, De Silva M, Hanlon C, Fekadu A. Community-based rehabilitation intervention for people with schizophrenia in Ethiopia (RISE): results of a 12-month cluster-randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e530-e542. doi: 10.1016/S2214-109X(22)00027-4. Erratum In: Lancet Glob Health. 2022 Jun;10(6):e797.
- Asher L, Fekadu A, Teferra S, De Silva M, Pathare S, Hanlon C. "I cry every day and night, I have my son tied in chains": physical restraint of people with schizophrenia in community settings in Ethiopia. Global Health. 2017 Jul 11;13(1):47. doi: 10.1186/s12992-017-0273-1.
- Asher L, De Silva M, Hanlon C, Weiss HA, Birhane R, Ejigu DA, Medhin G, Patel V, Fekadu A. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial. Trials. 2016 Jun 24;17(1):299. doi: 10.1186/s13063-016-1427-9.
- De Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, Patel V. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials. 2014 Jul 5;15:267. doi: 10.1186/1745-6215-15-267.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (实际的)
2017年3月26日
研究完成 (实际的)
2017年5月8日
研究注册日期
首次提交
2014年6月3日
首先提交符合 QC 标准的
2014年6月9日
首次发布 (估计)
2014年6月10日
研究记录更新
最后更新发布 (实际的)
2017年5月10日
上次提交的符合 QC 标准的更新
2017年5月9日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 7035
- 100142/Z/12/Z (其他赠款/资助编号：Wellcome Trust)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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