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

9. maj 2017 opdateret af: London School of Hygiene and Tropical Medicine

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

166

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Etiopien
      • Addis Ababa, Etiopien
        • Department of Psychiatry, College of Health Sciences, Addis Ababa University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Community-based rehabilitation
Andet: Facility based care
Aktiv komparator: 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.
Andet: Facility based care

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Disability (36-item WHODAS (World Health Organisation Disability Assessment Schedule) 2.0)
Tidsramme: 12 months
12 months

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Discrimination (DISC-12)
Tidsramme: 6 and 12 months
Potential mediator
6 and 12 months
Health service use and costs
Tidsramme: 6 and 12 months
Potential mediator
6 and 12 months
Depression (PHQ-9+1)
Tidsramme: 6 and 12 months
Potential confounder
6 and 12 months
Access/ adherence to CBR and reasons for non-adherence
Tidsramme: 6 and 12 months
Potential mediator
6 and 12 months
Social support (OSLO-3)
Tidsramme: 6 and 12 months
Potential mediator
6 and 12 months
Stigma and discrimination (WHO Family Interview Schedule Stigma section)
Tidsramme: 6 and 12 months
6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

London School of Hygiene and Tropical Medicine

Samarbejdspartnere

Addis Ababa University

Efterforskere

  • Ledende efterforsker: Mary De Silva, PhD MSc, London School of Hygiene and Tropical Medicine
  • Ledende efterforsker: Abebaw Fekadu, Addis Ababa University Department of Psychiatry

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2015

Primær færdiggørelse (Faktiske)

26. marts 2017

Studieafslutning (Faktiske)

8. maj 2017

Datoer for studieregistrering

Først indsendt

3. juni 2014

Først indsendt, der opfyldte QC-kriterier

9. juni 2014

Først opslået (Skøn)

10. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7035
  • 100142/Z/12/Z (Andet bevillings-/finansieringsnummer: Wellcome Trust)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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