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Comparative Effectiveness of IIMR Versus CDSMP

Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03966872
Enrollment
601
Registered
2019-05-29
Start date
2019-09-02
Completion date
2027-01-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Mental Illness

Keywords

integrated health, mental health, illness management, cardiovascular disease, physical health

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).

Interventions

Education and skills training groups on illness management of chronic medical and psychiatric illness.

Education and skills training groups on illness management of chronic conditions

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Knowledge and skills in illness self-management using the Illness Management and Recovery ScaleChange from Baseline to 12 monthsChange in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.
Change in Patient Activation on the Patient Activation Measure (PAM)Change from Baseline to 12 monthsChange in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.
Change in Acute Hospital Events from Electronic Medical Record Review.Change from Baseline to 12 monthsChange in the number of acute hospital events. At each assessment a combination of participant report and verified information from mental health clinics will be used to validate the number acute hospital events.
Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 ScaleChange from Baseline to 12 weeksChange in score on this measure, which was developed as part of the study plan because no suitable scale existed to assess knowledge and safety behaviors for COVID-19. Scores range from 0-100%, with higher scores indicating greater knowledge and enactment of safety behaviors.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSarah Pratt

Dartmouth-Hitchcock Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026