Chronic Disease, Mental Illness
Conditions
Keywords
integrated health, mental health, illness management, cardiovascular disease, physical health
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.
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). The 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.
Interventions
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.
BEHAVIORALChronic Disease Self-Management Program
Education and skills training groups on illness management of chronic conditions
Sponsors
Patient-Centered Outcomes Research Institute
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (NCT03966872).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received COVID-19 Vaccine | Baseline to 12 Weeks | change in status from baseline to follow up, receipt of vaccination or not. |
Countries
United States
Participant flow
Pre-assignment details
All enrolled participants were actively participating in the parent project and maintained the randomization status from the parent study for the COVID intervention (see NCT03966870).
Participants by arm
| Arm | Count |
|---|---|
| Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT: In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.
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. | 80 |
| Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)
Chronic Disease Self-Management Program: Education and skills training groups on illness management of chronic conditions | 82 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
Baseline characteristics
| Characteristic | Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT: | Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 80 Participants | 158 Participants |
| Age, Continuous | 48.0 years STANDARD_DEVIATION 9.9 | 49.1 years STANDARD_DEVIATION 10.3 | 48.5 years STANDARD_DEVIATION 10.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 28 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 48 Participants | 88 Participants |
| Region of Enrollment United States | 80 participants | 82 participants | 162 participants |
| Sex/Gender, Customized Female | 53 Participants | 61 Participants | 114 Participants |
| Sex/Gender, Customized Male | 26 Participants | 21 Participants | 47 Participants |
| Sex/Gender, Customized Transgender/Other | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 1 / 82 |
| other Total, other adverse events | 0 / 80 | 0 / 82 |
| serious Total, serious adverse events | 0 / 80 | 0 / 82 |
Outcome results
Primary
Number of Participants Who Received COVID-19 Vaccine
change in status from baseline to follow up, receipt of vaccination or not.
Time frame: Baseline to 12 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT: | Number of Participants Who Received COVID-19 Vaccine | 56 Participants |
| Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: | Number of Participants Who Received COVID-19 Vaccine | 50 Participants |