跳至主要内容
临床试验/NCT05467982
NCT05467982已完成不适用

Brief Intervention to Increase COVID-19 Knowledge in People With Serious Mental Illness

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
164
试验地点
2
主要终点
Number of Participants Who Received COVID-19 Vaccine

研究概览

简要总结

The study will enroll 600 people with serious mental illness who receive services at Centerstone in KY or TN and will compare two different evidence-based self-management interventions: Integrated Illness Management and Recovery (I-IMR), a program developed by the study team at Dartmouth that trains people with serious mental illness on physical and mental health self-management, and the Stanford Chronic Disease Self-Management Program (CDSMP), a program largely focused on physical health self-management that has been used widely in the general population. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.

详细描述

The proposed study will be the first to compare two commonly used but substantially different, evidence-based self-management interventions. Integrated Illness Management and Recovery (I-IMR), is an individually-tailored, 16-session, integrated program combining both physical and mental health self-management specifically developed for people with SMI. In contrast, the Stanford Chronic Disease Self-Management Program (CDSMP) is a group-based, 6-session, chronic disease self-management program largely focused on physical health self-management alone. I-IMR is delivered by community mental health providers or by community outreach workers, while CDSMP is co-delivered by two peers or by a health professional and a peer. Both programs have been widely recommended, disseminated, and used. The proposed parent study will randomize people with serious mental illness to I-IMR (n=300) and CDSMP (n=300).

The COVID-related Enhancement will involve enrolling 150 participants from the parent project to an evaluation of an additional I-IMR module compared to usual care during the pandemic. The I-IMR module will be delivered by trained interventionists in 3 calls over 3 weeks to n=75 I-IMR participants. The I-IMR participants and CDSMP participants will continue to receive Usual Care, consisting of generic support calls from clinicians at the study sites. Baseline, and 6, 9, and 12 week assessments will evaluate the effectiveness of the COVID-19 module that will be added to I-IMR.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Serious Mental Illness (diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or chronic depression with moderate impairment in functioning) receiving services at Centerstone(KY and TN)
  • •Diagnosis of a chronic medical condition increasing risk of early mortality from cardiovascular or respiratory disease (e.g., diabetes, hyperlipidemia, hypertension, COPD, heart failure, tobacco dependence, obesity), and at least 1 ER visit or hospitalization within the past year or judgment by the treatment team of substantial need for illness self-management training.

排除标准

  • •Consumers who do not speak English
  • •Consumers with either no, or a well-controlled medical condition will not be included
  • •Individuals residing in a nursing home or other institution
  • •Evidence of significant cognitive impairment as indicated by a Mini Mental Status Examination score <24, will be excluded
  • •Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project (NCT03966872).

研究组 & 干预措施

Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:

Experimental

In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.

干预措施: Integrated Illness Management and Recovery (Behavioral)

Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:

Experimental

No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)

干预措施: Chronic Disease Self-Management Program (Behavioral)

结局指标

主要结局

Number of Participants Who Received COVID-19 Vaccine

时间窗: Baseline to 12 Weeks

change in status from baseline to follow up, receipt of vaccination or not.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Pratt

Principal Investigator

Dartmouth-Hitchcock Medical Center

研究点 (2)

Loading locations...

相似试验