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临床试验/NCT03892473
NCT03892473Unknown不适用

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

University of Skopje2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
2
主要终点
Changes in daily functioning

研究概览

简要总结

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).

详细描述

The overall goal of the study is 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 upscaling the implementation of a community-based service delivery model in Montenegro. Effectiveness component of the trial: Multidisciplinary community mental health teams for people with SMI. The intervention condition offers flexible, assertive community treatment (FACT) in the community for people with SMI. FACT can intensify (e.g. provide more intensive treatment in the form of daily home visits, crisis care at home, more intensive evidence-based psycho-social and pharmacological treatments) or provide less intensive treatment depending on client need. It can also provide less intensive care during non-crisis periods, offering routine home treatment where a combination of psychological and pharmacological treatments (e.g. cognitive behavioral therapy, motivational interviewing, family-based interventions) are offered, as well as care processes (reviewing recovery and crisis/treatment plans, and the clients' Wellness Recovery Action Plan), and social care interventions (assistance in obtaining or maintaining employment, looking for reasonable accommodation options). Care offered in this project in the intervention condition will be provided by a multidisciplinary community mental health team (CMHT), consisting of a diverse set of professionals including psychiatrists, psychologists, nurses, and social workers, that deliver integrated medical and social care that are focused on (symptomatic-, functional- and personal-) recovery. CMHTs will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of sub-clinical psychosis and bipolar disorder, ACT, 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 illnesses will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioral therapies, combined with medication management and identifying employment (paid and unpaid options) and support in finding and maintaining this employment, (Wellness Recovery Action Plan (WRAP) recovery groups and housing opportunities. Comparison condition: Usual care Health care settings and their providers randomized to the control condition receive usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Flexible Assertive Community Treatment (FACT)

Experimental

Patients with SMI, receiving evidence-based interventions by the community mental health teams (CMHTs), inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.

干预措施: Community mental health teams (CMHT) (Other)

Care as usual (CAU)

Active Comparator

Active Comparator: CAU (Care as usual) Patients with SMI receiving usual care, meaning mostly medical treatment

干预措施: Care as usual (CAU) (Other)

结局指标

主要结局

Changes in daily functioning

时间窗: : Baseline, 12 months and 18 months

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.

次要结局

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

研究者

发起方
University of Skopje
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stojan Bajraktarov

Director

University of Skopje

研究点 (2)

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