Comparative Effectiveness of IIMR Versus CDSMP

NCT03966872 | Recruiting DMC

• 1 other identifier: D19103 31245
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Illness; Chronic Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Integrated Illness Management and Recovery (I-IMR):

EXPERIMENTAL

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

Stanford Chronic Disease Self-Management Program (CDSMP):

EXPERIMENTAL

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

Interventions

Integrated Illness Management and Recovery BEHAVIORAL

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

Integrated Illness Management and Recovery (I-IMR):

Chronic Disease Self-Management Program BEHAVIORAL

Education and skills training groups on illness management of chronic conditions

Stanford Chronic Disease Self-Management Program (CDSMP):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Seven Counties Services

Louisville, Kentucky, 40220, United States

RECRUITING

Centerstone

Nashville, Tennessee, 37228, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Chronic Disease; Psychological Well-Being; Cardiovascular Diseases

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sarah Pratt

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Santos, MSW

CONTACT

603-226-6804; Meghan.M.Santos@Dartmouth.edu

Gail Williams, MS

CONTACT

603-226-6803; Gail.E.Williams@Dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 29, 2019
• Study Start: September 2, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

US (2)