Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe (RECOVER-E)
Primary Purpose
Mental Disorders, Severe
Status
Unknown status
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Mobile team community mental health services
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Disorders, Severe
Eligibility 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:
- 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
Sites / Locations
- Spitalul de Psihiatrie Cronici Siret
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile team community mental health services
Current clinical services
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03884933
First Posted
March 20, 2019
Last Updated
May 14, 2019
Sponsor
Liga Romana pentru Sanatate Mintala
Collaborators
Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania
1. Study Identification
Unique Protocol Identification Number
NCT03884933
Brief Title
Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Acronym
RECOVER-E
Official Title
Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liga Romana pentru Sanatate Mintala
Collaborators
Psychiatric Hospital for Chronic Patients Siret, Suceava, Romania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Severe
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile team community mental health services
Arm Type
Experimental
Arm Title
Current clinical services
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Mobile team community mental health services
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome is global (personal and social) functioning, measured with the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0).
Description
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.
Time Frame
18 months
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility 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:
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
Facility Information:
Facility Name
Spitalul de Psihiatrie Cronici Siret
City
Siret
State/Province
Suceava
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34689733
Citation
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.
Results Reference
derived
PubMed Identifier
32476658
Citation
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.
Results Reference
derived
Learn more about this trial
Large Scale Implementation of Community Based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
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