Schizophrenia Clinical Trial
— RECOVER-EOfficial title:
Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health in Europe
Verified date | March 2020 |
Source | Special Psychiatric Hospital Kotor |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the intervention outcomes (clinical and service use outcomes) through patient-randomization in the implementation sites, as well as evaluates the implementation strategy chosen for the intervention and its impact on implementation outcomes (e.g. adoption, fidelity, acceptability and maintenance (continued implementation) of the intervention).
Status | Active, not recruiting |
Enrollment | 160 |
Est. completion date | June 1, 2022 |
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. |
Country | Name | City | State |
---|---|---|---|
Montenegro | ZU Specijalna bolnica za psihijatriju Dobrota Kotor | Kotor |
Lead Sponsor | Collaborator |
---|---|
Special Psychiatric Hospital Kotor | STICHTING TRIMBOS INSTITUT, NETHERLANDS |
Montenegro,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in daily functioning | World Health Organisation Disability Assessment Schedule 2 (WHO-DAS2) measures health and disability-level of functioning in 6 domains:1.Cognition - understanding and communicating; 2.Mobility - moving and getting around; 3.Self-care - attending to one's hygiene,dressing, eating and staying alone; 4.Getting along - interacting with others; 5. Life activities - domestic responsibilities, leisure, work and school; 6.Participation in community activities,in society.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 and 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:Dimension 1: Mobility; Dimension 2: Self-care;Dimension 3:Daily activities; Dimension 4: pain/discomfort; Dimension 5: 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 and 18 months |
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