Community-based Mental Health Care for People With Severe and Enduring Mental III Health (RECOVER-E)
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|ClinicalTrials.gov Identifier: NCT03922425|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2019
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Schizophrenia Severe Depression||Other: Community mental health team||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: Community mental health team (CMHT)
CMHTs will be multidisciplinary; that is, staff will be appointed to the CMHTs that include nurses, social workers, psychiatrists, psychologists, and in this project, a peer expert (a person with lived experience of mental health services). All staff within the CMHT will have defined roles and responsibilities that align with the staff functions, roles and linkages detailed in evidence-based service delivery models for community mental health teams. Participant will randomly be assigned to CMHT that will provide outreach mental health care during the project.
Other: Community mental health team
CMHT will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of subclinical psychosis and bipolar disorder, and intensive case management. Integrated care (i.e. health and social care interventions) will be provided to all clients. Furthermore, health and social care evidence-based interventions for severe mental illness (SMI) will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioural therapies, combined with medication management and identifying employment (paid and non paid options) and support in finding and maintaining this employment, recovery groups and housing opportunities.
Other Name: CMHT
|No Intervention: Standard care|
- Changes in daily functioning [ Time Frame: Baseline, 12 months and 18 months ]World Health Organisation Disability Assessment Schedule 2 (WHODAS2) measures health and disability-level of functioning in 6 domains:Cognition, Mobility, Self-care,Getting along, Life activities, Participation in community activities.The instrument is self-reporting; can be administered by a health worker if needed. Answers are distributed into 5 categories:"none","mild","moderate","severe"and"extreme or cannot do". It ends with 3 items where answers are presented as number of days (when difficulties were present). Score on any dimension ranges 0 to 7, results are depicted in a diagram which reflects relation between dimensions(the higher the score, the lower level of difficulties/better functioning) and changes over time
- Change in health-related quality of life [ Time Frame: Baseline, 12 months and 18 months ]Euro Quality of Life Index (Euro QoL 5-D 3-L). The instrument measures five dimensions: Mobility, Self-care, Daily activities, Pain/Discomfort and Anxiety/ Depression. Each dimension can be rated at three levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 33333 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.
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): NCT03922425
|Mental Health Center "Nikola Shipkovenky"|