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RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) (RISE)

Primary Purpose

Schizophrenia Spectrum Disorder, Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Community-based rehabilitation
Facility based care
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia Spectrum Disorder focused on measuring Schizophrenia, Psychotic disorders, Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, College of Health Sciences, Addis Ababa University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community-based rehabilitation and facility based care

Facility-based care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)

Secondary Outcome Measures

Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))
Clinical Global Impression (CGI)
Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))
Disability (36-item WHODAS 2.0)
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.
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)
Medication adherence (4 item Morisky Medication Adherence Scale)
Engagement with facility based care
Potential mediator
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.
Nutritional status (BMI)
Serious adverse events
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).
Caregiver burden (WHO Family Interview Schedule Impact section)
Caregiver depression (PHQ9 +1)
Patient medication adherence
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.

Full Information

First Posted
June 3, 2014
Last Updated
May 9, 2017
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Addis Ababa University
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1. Study Identification

Unique Protocol Identification Number
NCT02160249
Brief Title
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
Acronym
RISE
Official Title
RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 26, 2017 (Actual)
Study Completion Date
May 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Addis Ababa University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Spectrum Disorder, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Keywords
Schizophrenia, Psychotic disorders, Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community-based rehabilitation and facility based care
Arm Type
Experimental
Arm Description
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.
Arm Title
Facility-based care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community-based rehabilitation
Intervention Type
Other
Intervention Name(s)
Facility based care
Primary Outcome Measure Information:
Title
Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))
Time Frame
6 and 12 months
Title
Clinical Global Impression (CGI)
Time Frame
6 and 12 months
Title
Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))
Time Frame
6 and 12 months
Title
Disability (36-item WHODAS 2.0)
Time Frame
6 months
Title
Functioning (indigenous functioning scale)
Description
Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.
Time Frame
6 and 12 months
Title
Economic activity of patient (employment, income and household work)
Description
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)
Time Frame
6 and 12 months
Title
Medication adherence (4 item Morisky Medication Adherence Scale)
Time Frame
6 and 12 months
Title
Engagement with facility based care
Description
Potential mediator
Time Frame
6 and 12 months
Title
Proportion with human rights problems (chaining or restraint)- self-reported
Description
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.
Time Frame
6 and 12 months
Title
Nutritional status (BMI)
Time Frame
6 and 12 months
Title
Serious adverse events
Time Frame
6 and 12 months
Title
Economic activity of caregiver
Description
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).
Time Frame
6 and 12 months
Title
Caregiver burden (WHO Family Interview Schedule Impact section)
Time Frame
6 and 12 months
Title
Caregiver depression (PHQ9 +1)
Time Frame
6 and 12 months
Title
Patient medication adherence
Time Frame
6 and 12 months
Title
Proportion with human rights problems (chaining or restraint)- Caregiver-reported
Description
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.
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
Discrimination (DISC-12)
Description
Potential mediator
Time Frame
6 and 12 months
Title
Health service use and costs
Description
Potential mediator
Time Frame
6 and 12 months
Title
Depression (PHQ-9+1)
Description
Potential confounder
Time Frame
6 and 12 months
Title
Access/ adherence to CBR and reasons for non-adherence
Description
Potential mediator
Time Frame
6 and 12 months
Title
Social support (OSLO-3)
Description
Potential mediator
Time Frame
6 and 12 months
Title
Stigma and discrimination (WHO Family Interview Schedule Stigma section)
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary De Silva, PhD MSc
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abebaw Fekadu
Organizational Affiliation
Addis Ababa University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, College of Health Sciences, Addis Ababa University
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35303462
Citation
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.
Results Reference
derived
PubMed Identifier
28693614
Citation
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.
Results Reference
derived
PubMed Identifier
27342215
Citation
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.
Results Reference
derived
PubMed Identifier
24996765
Citation
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.
Results Reference
derived

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RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

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