Comparative Effectiveness of IIMR Versus CDSMP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03966872|
Recruitment Status : Active, not recruiting
First Posted : May 29, 2019
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mental Illness Chronic Disease||Behavioral: Integrated Illness Management and Recovery Behavioral: Chronic Disease Self-Management Program||Not Applicable|
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).
Our 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program|
|Actual Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||March 2024|
Experimental: Integrated Illness Management and Recovery (I-IMR):
Participants assigned to I-IMR will receive 2 individual sessions to discuss principles of recovery and set personally meaningful goals, with the remainder of the 14 I-IMR sessions delivered in groups of 8-10 (to enable individual tailoring)
Behavioral: Integrated Illness Management and Recovery
Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
Experimental: Stanford Chronic Disease Self-Management Program (CDSMP):
Participants randomly assigned get a 6-session group-based educational program co-delivered by two peers (lay people who have successfully managed a chronic illness) or a peer and a professional
Behavioral: Chronic Disease Self-Management Program
Education and skills training groups on illness management of chronic conditions
- Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale [ Time Frame: Change from Baseline to 12 months ]Change 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) [ Time Frame: Change from Baseline to 12 months ]Change 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. [ Time Frame: Change from Baseline to 12 months ]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.
- Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale [ Time Frame: Change from Baseline to 12 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966872
|United States, Kentucky|
|Seven Counties Services|
|Louisville, Kentucky, United States, 40220|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37228|
|Principal Investigator:||Sarah Pratt||Dartmouth-Hitchcock Medical Center|