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Comparative Effectiveness of IIMR Versus CDSMP

Primary Purpose

Mental Illness, Chronic Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Integrated Illness Management and Recovery

Chronic Disease Self-Management Program

About this trial

This is an interventional health services research trial for Mental Illness focused on measuring integrated health, mental health, illness management, cardiovascular disease, physical health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seven Counties ServicesRecruiting
CenterstoneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Integrated Illness Management and Recovery (I-IMR):

Stanford Chronic Disease Self-Management Program (CDSMP):

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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 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 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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03966872

First Posted

May 1, 2019

Last Updated

February 13, 2023

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT03966872

Brief Title

Comparative Effectiveness of IIMR Versus CDSMP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2019 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mental Illness, Chronic Disease

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Integrated Illness Management and Recovery (I-IMR):

Arm Type

Experimental

Arm Description

Arm Title

Stanford Chronic Disease Self-Management Program (CDSMP):

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Integrated Illness Management and Recovery

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Chronic Disease Self-Management Program

Intervention Description

Education and skills training groups on illness management of chronic conditions

Primary Outcome Measure Information:

Title

Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale

Description

Change in knowledge and skills for illness self-management. Range of scores from 15-75 with higher scores meaning better illness self-management.

Time Frame

Change from Baseline to 12 months

Title

Change in Patient Activation on the Patient Activation Measure (PAM)

Description

Change in Patient Activation (engagement in health care). Maximum score of 100, higher scores meaning greater activation.

Time Frame

Change from Baseline to 12 months

Title

Change in Acute Hospital Events from Electronic Medical Record Review.

Description

Time Frame

Change from Baseline to 12 months

Title

Knowledge and Behaviors for Preventing Catching and Spreading COVID-19 Scale

Description

Time Frame

Change from Baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Skyla Marceau

Phone

603-229-5412

skyla.marceau@dartmouth.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Meghan Santos

Phone

603-229-5413

Meghan.Santos@Dartmouth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Pratt

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seven Counties Services

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40220

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Theresa Watson, RN, MS, CPHQ

Phone

502-436-5696

Facility Name

Centerstone

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37228

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mandi Ryan

Phone

615-574-1195

12. IPD Sharing Statement

Learn more about this trial

Comparative Effectiveness of IIMR Versus CDSMP

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