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Clinical Trials/NCT03862209
NCT03862209
Unknown
N/A

Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe

Klinički Bolnički Centar Zagreb1 site in 1 country200 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Severe Mental Disorder
Sponsor
Klinički Bolnički Centar Zagreb
Enrollment
200
Locations
1
Primary Endpoint
Changes in daily functioning
Last Updated
7 years ago

Overview

Brief Summary

To contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and up scaling the implementation of a community-based service delivery model in Croatia.

Detailed Description

For nearly 900 million people living in Europe, mental disorders constitute the most significant yet most neglected public health problem: depression affects an estimated 30.3 million Europeans, and psychotic disorders 5 million Europeans. People with severe and enduring mental ill health want the same things out of life as other citizens but are often placed in a vulnerable position and are hence afforded less opportunities to attain their goals and thus experience a lower quality of life, and have a lower life expectancy compared to the general population. For many countries that have undergone mental health services reform or have health systems in transition, efforts to make such comprehensive community-based mental health services available resulted in short-lived outcomes or are still to demonstrate substantial impact. RECOVER-E's aims to ensure well-functioning community mental health teams in 5 countries in Europe (Macedonia, Romania, Bulgaria, Croatia, and Montenegro), which will serve as the central node for coordination and provision of care for people with SMI. Our project narrows the implementation gap by going beyond infrastructure changes and pursuing 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 uptake after the project's life span. RECOVER-E will: 1) Develop evidence based care pathways and treatment protocols for transition to scale for regional and national decision makers in 5 implementation sites; 2) Establish a peer to peer capacity building partnership in community mental health by linking a European expert panel with key stakeholders in 5 implementation sites to co-create community mental health services for people with SMI) 3) Evaluate intervention elements that will enhance sustainable adoption and implementation of community-based mental health care for people with SMI, by carrying out implementation research.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
July 1, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Klinički Bolnički Centar Zagreb
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults (ages 18-65), current service users, with severe and enduring mental ill-health, which, for clinical purposes, typically relates to diagnostic categories of bipolar disorder, severe depression, or schizophrenia. We use the following definition for SMI:
  • Presence of a psychiatric disorder that requires care and treatment (so, they are NOT in symptom remission)
  • Has severe limitations in social and community functioning (i.e. they are not in functional remission)
  • These problems are not transient (e.g. temporary, one-off) in nature (They are systematic and long-term)
  • Coordinated care provided by care networks or teams is needed to implement the treatment plan

Exclusion Criteria

  • Exclusion criteria at the patient level includes patients who do not consent to their data being collected who are part of the intervention or control conditions, those who are under the age of 18 at the start of the study.

Outcomes

Primary Outcomes

Changes in daily functioning

Time Frame: baseline, 12 months, 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

Secondary Outcomes

  • Change in health-related quality of life(baseline, 12 months, 18 months)

Study Sites (1)

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