RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02160249
• Date of registration: 03/06/2014
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) RISE
• Scientific title: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
• Date of first enrolment: September 2015
• Target sample size: 166
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02160249
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ethiopia

Contacts

• Name: Abebaw Fekadu
• Affiliation: Addis Ababa University Department of Psychiatry

• Name: Mary De Silva, PhD MSc
• Affiliation: London School of Hygiene and Tropical Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Schizophrenia Spectrum Disorder

Schizophreniform Disorder

Schizoaffective Disorder

Intervention(s)

Behavioral: Community-based rehabilitation

Other: Facility based care

Primary Outcome(s)

Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0) [Time Frame: 12 months]

Secondary Outcome(s)

Economic activity of caregiver [Time Frame: 6 and 12 months]

Proportion with human rights problems (chaining or restraint)- self-reported [Time Frame: 6 and 12 months]

Caregiver burden (WHO Family Interview Schedule Impact section) [Time Frame: 6 and 12 months]

Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE)) [Time Frame: 6 and 12 months]

Caregiver depression (PHQ9 +1) [Time Frame: 6 and 12 months]

Disability (36-item WHODAS 2.0) [Time Frame: 6 months]

Nutritional status (BMI) [Time Frame: 6 and 12 months]

Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E)) [Time Frame: 6 and 12 months]

Economic activity of patient (employment, income and household work) [Time Frame: 6 and 12 months]

Engagement with facility based care [Time Frame: 6 and 12 months]

Clinical Global Impression (CGI) [Time Frame: 6 and 12 months]

Serious adverse events [Time Frame: 6 and 12 months]

Functioning (indigenous functioning scale) [Time Frame: 6 and 12 months]

Patient medication adherence [Time Frame: 6 and 12 months]

Medication adherence (4 item Morisky Medication Adherence Scale) [Time Frame: 6 and 12 months]

Proportion with human rights problems (chaining or restraint)- Caregiver-reported [Time Frame: 6 and 12 months]

Secondary ID(s)

7035

100142/Z/12/Z

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Addis Ababa University