Clinical trial NCT03966872: Comparative Effectiveness of IIMR Versus CDSMP
Official title: Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Illness
Chronic Disease
Keywords: integrated health
mental health
illness management
cardiovascular disease
physical health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-05-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale
timeFrame: Change from Baseline to 12 months
measure: Change in Patient Activation on the Patient Activation Measure (PAM)
timeFrame: Change from Baseline to 12 months
measure: Change in Acute Hospital Events from Electronic Medical Record Review.
timeFrame: Change from Baseline to 12 months
measure: Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Seven Counties Services
state: Kentucky
city: Nashville
country: United States
facility: Centerstone
state: Tennessee
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Sarah Pratt
role: PRINCIPAL_INVESTIGATOR
References: