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Comparative Effectiveness of IIMR Versus CDSMP

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ClinicalTrials.gov Identifier: NCT03966872
Recruitment Status : Active, not recruiting
First Posted : May 29, 2019
Last Update Posted : November 23, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Sarah Pratt, Dartmouth-Hitchcock Medical Center

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. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 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

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).

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Locations
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United States, Kentucky
Seven Counties Services
Louisville, Kentucky, United States, 40220
United States, Tennessee
Centerstone
Nashville, Tennessee, United States, 37228
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Sarah Pratt Dartmouth-Hitchcock Medical Center
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Responsible Party: Sarah Pratt, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03966872    
Other Study ID Numbers: D19103 31245
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Pratt, Dartmouth-Hitchcock Medical Center:
integrated health
mental health
illness management
cardiovascular disease
physical health
Additional relevant MeSH terms:
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Chronic Disease
Mental Disorders
Disease Attributes
Pathologic Processes