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Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe (RECOVER-E)

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ClinicalTrials.gov Identifier: NCT03884933
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania
Information provided by (Responsible Party):
Liga Romana pentru Sanatate Mintala

Brief Summary:
RECOVER-E's main purpose is to ensure well-functioning community mental health teams in five countries in Europe; these teams will serve as the central node for the coordination and provision of care for people with severe mental illness (SMI). At present, specialist teams providing comprehensive, evidence-based mental health care are not available or functional in many countries in Eastern Europe, and the care pathways and evidence-based treatment protocols for community-based and recovery-oriented mental healthcare have not been defined or tailored to local situations and therefore, are not being implemented. This project aims to implement and study community-based initiatives to narrow this gap. These efforts will emphasize the development of human resource capacity and care pathways that can be distilled in a comprehensive pathway to scale for regional and national decision-makers for potential project expansion and replication after the project period.

Condition or disease Intervention/treatment Phase
Mental Disorders, Severe Other: Mobile team community mental health services Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile team community mental health services Other: Mobile team community mental health services
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.

No Intervention: Current clinical services



Primary Outcome Measures :
  1. The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). [ Time Frame: 18 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

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:

  1. 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;
  2. has severe limitations in social and community functioning;
  3. problems are not transient in nature; the problems are systematic and long-term, and potentially chronic, intermitted, and/or recurrent;
  4. coordinated care provided by care networks or multidisciplinary teams is needed to deliver treatment
  5. Patients with prevalence of suicidal behaviours (including suicide attempts)

Exclusion criteria are:

  1. Patients under the age of 18
  2. Patients with dementia or Alzheimer's disease
  3. 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

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): NCT03884933


Locations
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Romania
Spitalul de Psihiatrie Cronici Siret
Siret, Suceava, Romania
Sponsors and Collaborators
Liga Romana pentru Sanatate Mintala
Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liga Romana pentru Sanatate Mintala
ClinicalTrials.gov Identifier: NCT03884933    
Other Study ID Numbers: 779362
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders