Comparative Effectiveness of IIMR Versus CDSMP

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966872
• Other study ID #: D19103 31245
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: January 2027

Study information

• Verified date: March 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Meghan Santos, MSW
• Phone: 603-226-6804
• Email: Meghan.M.Santos[@]Dartmouth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Mental Disorders
• Mental Illness

Intervention

Behavioral:
• Integrated Illness Management and Recovery
Education and skills training groups on illness management of chronic medical and psychiatric illness.
• Chronic Disease Self-Management Program
Education and skills training groups on illness management of chronic conditions

Locations

Country	Name	City	State
United States	Seven Counties Services	Louisville	Kentucky
United States	Centerstone	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale	Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.	Change from Baseline to 12 months
Primary	Change in Patient Activation on the Patient Activation Measure (PAM)	Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.	Change from Baseline to 12 months
Primary	Change in Acute Hospital Events from Electronic Medical Record Review.	Change 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.	Change from Baseline to 12 months
Primary	Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale	Change 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.	Change from Baseline to 12 weeks