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临床试验/CTRI/2022/03/041005
CTRI/2022/03/041005尚未招募不适用

NIHR Research and Innovation for Global Health Transformation on Iimproving outcomes for people with psychosis in Pakistan and India- enhancing the Effectiveness of Community-based care(PIECEs)

National Institute for Health Research1 个研究点 分布在 1 个国家目标入组 448 人开始时间: 2022年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
448
试验地点
1
主要终点
Subjective quality of life measured using the Manchester Short Assessment of Quality of Life called MANSA

研究概览

简要总结

About 5-8% of the world’s population suffer from a Severe Mental Illness (SMI), presenting a major challenge worldwide. SMI causes significant distress to affected people, families and wider communities, generating high costs through loss of productivity and ongoing healthcare use. The burden is greatest in low- and middle-income countries (LMICs), where there may be a lack of financial resources and qualified staff to provide extensive specialised services. This study will explore, adapt and test a low-cost, generic approach (DIALOG+) that makes use of existing resources to improve community-based care for patients with psychosis and reduce the need for institutionalisation in India and Pakistan. DIALOG+ is an app-mediated intervention that has been shown to improve mental health outcomes. The research will also develop a participatory arts work that will focus on giving voice to people with psychosis and their experiences as well as engage local communities, opening conversations about mental illness.

The overall aim of the study is to test the effectiveness and cost-effectiveness of DIALOG+ in improving the quality of community-based care for patients with psychosis in India and Pakistan.

The study will be conducted in India and Pakistan with 210 patients and 14 clinicians within each country. A clinician and their respective patients will be randomly divided into two groups. The study will involve clinicians using the app-based intervention called DIALOG+ in their routine sessions with patients. In one group the DIALOG+ app will be used to structure the conversation that takes place during the session. This involves going through a patient’s satisfaction level on various life domains and then discussing them further using a four-step solution-focused approach. In the second group, clinicians will only use the app to complete the satisfaction scale with patients. Data will be collected at baseline, at 6 months after the intervention, and at 12 months. Data collection will include different tools to measure quality of life, symptom severity, objective social functioning, economic/cost-effectiveness data and health alliance. Further interviews will take place with patients and clinicians at the end of the intervention period (6 months) to gain a more in-depth understanding of the experience of using DIALOG+. Data will be analysed to help the researchers understand how effective and accepted the DIALOG+ intervention was in the sample population.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of psychosis Aged over 18 years Capacity for informed consent Can speak and understand the local language Has a low quality of life scoring less than 5 on the MANSA for clinicians any professional background having regular contact with patients with psychosis.

排除标准

  • Dementia and or significant cognitive impairment and or severe learning disability Organic psychosis or drug induced psychosis if given as the primary diagnosis Unable to provide informed consent clinicians who do not have regular contact with patients with psychosis and do not speak the local language.

结局指标

主要结局

Subjective quality of life measured using the Manchester Short Assessment of Quality of Life called MANSA

时间窗: 6 months 12 months

次要结局

  • Hospitalisation measured using the client Service resource inventory(Symptoms measured using brief psychiatry rating scale at baseline 6 months and 12 months)

研究者

申办方类型
Government funding agency

研究点 (1)

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