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

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ClinicalTrials.gov Identifier: NCT02160249
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
Addis Ababa University
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum Disorder Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Behavioral: Community-based rehabilitation Other: Facility based care Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia): a Cluster-randomised Trial
Study Start Date : September 2015
Actual Primary Completion Date : March 26, 2017
Actual Study Completion Date : May 8, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Community-based rehabilitation and facility based care

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.

 Behavioral: Community-based rehabilitation
Other: Facility based care
Active Comparator: Facility-based care
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.
 Other: Facility based care


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

Secondary Outcome Measures :
  1. Symptom severity (Brief Psychiatric Rating Scale- Expanded version (BPRS-E)) [ Time Frame: 6 and 12 months ]
  2. Clinical Global Impression (CGI) [ Time Frame: 6 and 12 months ]
  3. Relapse (Longitudinal Interval Follow up Evaluation: DSM-IV version (LIFE)) [ Time Frame: 6 and 12 months ]
  4. Disability (36-item WHODAS 2.0) [ Time Frame: 6 months ]
  5. Functioning (indigenous functioning scale) [ Time Frame: 6 and 12 months ]
    Scale is currently under development. It is being designed and validated to measure functioning in people with severe mental illness in rural Ethiopia.

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

  7. Medication adherence (4 item Morisky Medication Adherence Scale) [ Time Frame: 6 and 12 months ]
  8. Engagement with facility based care [ Time Frame: 6 and 12 months ]
    Potential mediator

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

  10. Nutritional status (BMI) [ Time Frame: 6 and 12 months ]
  11. Serious adverse events [ Time Frame: 6 and 12 months ]
  12. Economic activity of caregiver [ Time Frame: 6 and 12 months ]
    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).

  13. Caregiver burden (WHO Family Interview Schedule Impact section) [ Time Frame: 6 and 12 months ]
  14. Caregiver depression (PHQ9 +1) [ Time Frame: 6 and 12 months ]
  15. Patient medication adherence [ Time Frame: 6 and 12 months ]
  16. Proportion with human rights problems (chaining or restraint)- Caregiver-reported [ Time Frame: 6 and 12 months ]
    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.


Other Outcome Measures:
  1. Discrimination (DISC-12) [ Time Frame: 6 and 12 months ]
    Potential mediator

  2. Health service use and costs [ Time Frame: 6 and 12 months ]
    Potential mediator

  3. Depression (PHQ-9+1) [ Time Frame: 6 and 12 months ]
    Potential confounder

  4. Access/ adherence to CBR and reasons for non-adherence [ Time Frame: 6 and 12 months ]
    Potential mediator

  5. Social support (OSLO-3) [ Time Frame: 6 and 12 months ]
    Potential mediator

  6. Stigma and discrimination (WHO Family Interview Schedule Stigma section) [ Time Frame: 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160249


Locations
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Ethiopia
Department of Psychiatry, College of Health Sciences, Addis Ababa University
Addis Ababa, Ethiopia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Addis Ababa University
Investigators
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Principal Investigator: Mary De Silva, PhD MSc London School of Hygiene and Tropical Medicine
Principal Investigator: Abebaw Fekadu Addis Ababa University Department of Psychiatry
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02160249    
Other Study ID Numbers: 7035
100142/Z/12/Z ( Other Grant/Funding Number: Wellcome Trust )
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Keywords provided by London School of Hygiene and Tropical Medicine:
Schizophrenia
Psychotic disorders
Schizophrenia spectrum disorder (schizophrenia, schizoaffective disorder or schizophreniform disorder) using DSM-IV criteria
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
 Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders