RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial

Conditions
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Schizophrenia Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Intervention / Treatment
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* Behavioral: Community-based rehabilitation
* Other: Facility based care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-based rehabilitation and facility based care<br>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. | Behavioral: Community-based rehabilitation<br> <br> Other: Facility based care<br> <br> |
| Active Comparator: Facility-based care<br>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. | Other: Facility based care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Disability (36-item WHODAS 2.0) |  | 6 months | 
| Functioning (indigenous functioning scale) | Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia. | 6 and 12 months | 
| Economic activity of patient (employment, income and household work) | 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) | 6 and 12 months | 
| Medication adherence (4 item Morisky Medication Adherence Scale) |  | 6 and 12 months | 
| Engagement with facility based care | Potential mediator | 6 and 12 months | 
| Proportion with human rights problems (chaining or restraint)- self-reported | 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. | 6 and 12 months | 
| Nutritional status (BMI) |  | 6 and 12 months | 
| Serious adverse events |  | 6 and 12 months | 
| Economic activity of caregiver | 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). | 6 and 12 months | 
| Caregiver burden (WHO Family Interview Schedule Impact section) |  | 6 and 12 months | 
| Caregiver depression (PHQ9 +1) |  | 6 and 12 months | 
| Patient medication adherence |  | 6 and 12 months | 
| Proportion with human rights problems (chaining or restraint)- Caregiver-reported | 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. | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Psychotic disorders, Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria