Clinical trial NCT02160249: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)
Official title: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
First posted: 2014-06-10
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
timeFrame: 12 months
Secondary outcomes:
measure: Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))
timeFrame: 6 and 12 months
measure: Clinical Global Impression (CGI)
timeFrame: 6 and 12 months
measure: Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))
timeFrame: 6 and 12 months
measure: Disability (36-item WHODAS 2.0)
timeFrame: 6 months
measure: Functioning (indigenous functioning scale)
timeFrame: 6 and 12 months
measure: Economic activity of patient (employment, income and household work)
timeFrame: 6 and 12 months
measure: Medication adherence (4 item Morisky Medication Adherence Scale)
timeFrame: 6 and 12 months
measure: Engagement with facility based care
timeFrame: 6 and 12 months
measure: Proportion with human rights problems (chaining or restraint)- self-reported
timeFrame: 6 and 12 months
measure: Nutritional status (BMI)
timeFrame: 6 and 12 months
measure: Serious adverse events
timeFrame: 6 and 12 months
measure: Economic activity of caregiver
timeFrame: 6 and 12 months
measure: Caregiver burden (WHO Family Interview Schedule Impact section)
timeFrame: 6 and 12 months
measure: Caregiver depression (PHQ9 +1)
timeFrame: 6 and 12 months
measure: Patient medication adherence
timeFrame: 6 and 12 months
measure: Proportion with human rights problems (chaining or restraint)- Caregiver-reported
timeFrame: 6 and 12 months
Other outcomes:
measure: Discrimination (DISC-12)
timeFrame: 6 and 12 months
measure: Health service use and costs
timeFrame: 6 and 12 months
measure: Depression (PHQ-9+1)
timeFrame: 6 and 12 months
measure: Access/ adherence to CBR and reasons for non-adherence
timeFrame: 6 and 12 months
measure: Social support (OSLO-3)
timeFrame: 6 and 12 months
measure: Stigma and discrimination (WHO Family Interview Schedule Stigma section)
timeFrame: 6 and 12 months
Locations:
city: Addis Ababa
country: Ethiopia
facility: Department of Psychiatry, College of Health Sciences, Addis Ababa University
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Mary De Silva, PhD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Addis Ababa University Department of Psychiatry
name: Abebaw Fekadu
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.