Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health (RECOVER-E) Croatia

Schizophrenia Clinical Trial

— RECOVER-E  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862209
• Other study ID #: KBC Zagreb RECOVER-E
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2019
• Source: Klinicki Bolnicki Centar Zagreb
• Contact: Martina Rojnic Kuzman, A/Prof.
• Phone: +385 1 2388 888
• Email: mrojnic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Severe Depression
• Severe Mental Disorder

Intervention

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.

Locations

Country	Name	City	State
Croatia	KBC Zagreb	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Klinicki Bolnicki Centar Zagreb	STICHTING TRIMBOS INSTITUT, NETHERLANDS

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in daily functioning	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	baseline, 12 months, 18 months
Secondary	Change in health-related quality of life	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.	baseline, 12 months, 18 months