- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03884933
Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe (RECOVER-E)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
AIMS / OBJECTIVES The overall aim of Recover-E is to contribute to the implementation of a community-based service delivery model in five implementation sites in low and middle-income countries and vulnerable populations in high-income countries in Europe to improve the level of functioning, quality of life, and mental health outcomes for people with severe and enduring mental ill health (schizophrenia, bipolar disorder, depression).
RECOVER-E's specific project objectives are to:
- design, implement and evaluate recovery-oriented care for people with severe mental illness in community settings by recognizing the value of experiential knowledge through including peer experts as members of the community mental health teams
- identify intervention and program elements, as well as contextual factors, which enhance sustainable implementation of community-based mental healthcare for people with severe mental illness
- establish a peer-to-peer capacity building partnership in community mental health, by linking a European expert panel with key stakeholders in five implementation sites (policy makers, service managers, service providers, users, and carers) to co-create community health services for people with SMI
- develop evidence-based care pathways and treatment protocols and transition to scale for regional and national decision-makers, for continued implementation and scale up after the project's life span
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Suceava
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Siret, Suceava, Romania
- Spitalul de Psihiatrie Cronici Siret
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:The target population for inclusion in the study are consenting adults (ages 18-65 years) with severe mental illness (SMI), defined based on Deslespaul's conceptualisation of SMI:
- meets criteria for (and presence of) bipolar disorder, severe major depression, schizophrenia, schizophreniform, and schizoaffective disorder according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10). The person should require care and treatment and not be in symptomatic remission;
- has severe limitations in social and community functioning;
- problems are not transient in nature; the problems are systematic and long-term, and potentially chronic, intermitted, and/or recurrent;
- coordinated care provided by care networks or multidisciplinary teams is needed to deliver treatment
- Patients with prevalence of suicidal behaviours (including suicide attempts)
Exclusion criteria are:
- Patients under the age of 18
- Patients with dementia or Alzheimer's disease
- Patients for whom treatment is legally prescribed (in forensic psychiatry), however if they are discharged from the forensic ward, and still in need of treatment they can be included
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Mobile team community mental health services
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The intervention focuses on changing mental health care systems to be able to provide community-based mental health care for people with severe mental illness.
This will be done through the development and implementation of multidisciplinary community mental health teams (CMHTs) in each of the implementation sites, consisting of at least one nurse, psychiatrist, psychologist, social worker, and peer worker (person with lived experience of a severe mental illness).
The structure and delivery method of the community mental health teams is part of an evidence-based service delivery model providing flexible, assertive community mental health teams providing integrated services to people with severe mental illness (SMI) in order to structurally attain their recovery goals, as well as timely and appropriate care in the event of a crisis.
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Ingen inngripen: Current clinical services
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).
Tidsramme: 18 months
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The WHODAS 2.0 is a generic measure designed to measure functioning and disability as well as health-related quality of life based on the Internal Classification of Functioning (ICF) framework. The WHODAS 2.0 will be used as a continuous outcome in the clinical trial evaluation. The scale comes in 12- and 36-item versions. The 36-item version captures the level of functioning in six domains of life: Domain 1: Cognition - understanding and communicating Domain 2: Mobility - moving and getting around Domain 3: Self-care - attending to one's hygiene, dressing, eating and staying alone Domain 4: Getting along - interacting with other people Domain 5: Life activities - domestic responsibilities, leisure, work and school Domain 6: Participation - joining in community activities, participating in society The 12-item version helps to assess overall (global) functioning only. Therefore, it is planned to use the 36-itme self-report version of the WHODAS 2.0. |
18 months
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Roth C, Wensing M, Kuzman MR, Bjedov S, Medved S, Istvanovic A, Grbic DS, Simetin IP, Tomcuk A, Dedovic J, Djurisic T, Nica RI, Rotaru T, Novotni A, Bajraktarov S, Milutinovic M, Nakov V, Zarkov Z, Dinolova R, Walters BH, Shields-Zeeman L, Petrea I. Experiences of healthcare staff providing community-based mental healthcare as a multidisciplinary community mental health team in Central and Eastern Europe findings from the RECOVER-E project: an observational intervention study. BMC Psychiatry. 2021 Oct 24;21(1):525. doi: 10.1186/s12888-021-03542-2.
- Wijnen BFM, Smit F, Uhernik AI, Istvanovic A, Dedovic J, Dinolova R, Nica R, Velickovski R, Wensing M, Petrea I, Shields-Zeeman L. Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program. JMIR Res Protoc. 2020 Jun 1;9(6):e17454. doi: 10.2196/17454.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 779362
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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