Overview

This trial is active, not recruiting.

Conditions schizophrenia spectrum disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder
Treatments community-based rehabilitation, facility based care
Sponsor London School of Hygiene and Tropical Medicine
Collaborator Addis Ababa University
Start date September 2015
End date March 2017
Trial size 166 participants
Trial identifier NCT02160249, 100142/Z/12/Z, 7035

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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.
community-based rehabilitation
facility based care
(Active Comparator)
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

Primary Outcomes

Measure
Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
time frame: 12 months

Secondary Outcomes

Measure
Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))
time frame: 6 and 12 months
Clinical Global Impression (CGI)
time frame: 6 and 12 months
Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))
time frame: 6 and 12 months
Disability (36-item WHODAS 2.0)
time frame: 6 months
Functioning (indigenous functioning scale)
time frame: 6 and 12 months
Economic activity of patient (employment, income and household work)
time frame: 6 and 12 months
Medication adherence (4 item Morisky Medication Adherence Scale)
time frame: 6 and 12 months
Engagement with facility based care
time frame: 6 and 12 months
Proportion with human rights problems (chaining or restraint)- self-reported
time frame: 6 and 12 months
Nutritional status (BMI)
time frame: 6 and 12 months
Serious adverse events
time frame: 6 and 12 months
Economic activity of caregiver
time frame: 6 and 12 months
Caregiver burden (WHO Family Interview Schedule Impact section)
time frame: 6 and 12 months
Caregiver depression (PHQ9 +1)
time frame: 6 and 12 months
Patient medication adherence
time frame: 6 and 12 months
Proportion with human rights problems (chaining or restraint)- Caregiver-reported
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Principal investigator Mary De Silva, PhD MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine.