RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

Schizophrenia Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160249
• Other study ID #: 7035
• Secondary ID: 100142/Z/12/Z
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: May 9, 2017
• Start date: September 2015
• Est. completion date: May 8, 2017

Study information

• Verified date: May 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: May 8, 2017
• Est. primary completion date: March 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia Spectrum Disorder
• Schizophreniform Disorder

Intervention

Behavioral:
• Community-based rehabilitation

Other:
• Facility based care

Locations

Country	Name	City	State
Ethiopia	Department of Psychiatry, College of Health Sciences, Addis Ababa University	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Addis Ababa University

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Discrimination (DISC-12)	Potential mediator	6 and 12 months
Other	Health service use and costs	Potential mediator	6 and 12 months
Other	Depression (PHQ-9+1)	Potential confounder	6 and 12 months
Other	Access/ adherence to CBR and reasons for non-adherence	Potential mediator	6 and 12 months
Other	Social support (OSLO-3)	Potential mediator	6 and 12 months
Other	Stigma and discrimination (WHO Family Interview Schedule Stigma section)		6 and 12 months
Primary	Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)		12 months
Secondary	Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E))		6 and 12 months
Secondary	Clinical Global Impression (CGI)		6 and 12 months
Secondary	Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE))		6 and 12 months
Secondary	Disability (36-item WHODAS 2.0)		6 months
Secondary	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
Secondary	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
Secondary	Medication adherence (4 item Morisky Medication Adherence Scale)		6 and 12 months
Secondary	Engagement with facility based care	Potential mediator	6 and 12 months
Secondary	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
Secondary	Nutritional status (BMI)		6 and 12 months
Secondary	Serious adverse events		6 and 12 months
Secondary	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
Secondary	Caregiver burden (WHO Family Interview Schedule Impact section)		6 and 12 months
Secondary	Caregiver depression (PHQ9 +1)		6 and 12 months
Secondary	Patient medication adherence		6 and 12 months
Secondary	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