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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT: | Experimental | 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. |
|
| Stanford Chronic Disease Self-Management Program (CDSMP) ONLY: | Experimental | No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Illness Management and Recovery | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received COVID-19 Vaccine | change in status from baseline to follow up, receipt of vaccination or not. | Baseline to 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility for the COVID -related substudy is dependent on enrollment and participation in the parent project (NCT03966872).
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Pratt, PhD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seven Counties Services | Louisville | Kentucky | 40220 | United States | ||
| Centerstone |
There are no plans to share IPD at this time.
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2022 |
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| Chronic Disease Self-Management Program | Behavioral | Education and skills training groups on illness management of chronic conditions |
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| Nashville |
| Tennessee |
| 37228 |
| United States |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received COVID-19 Vaccine | change in status from baseline to follow up, receipt of vaccination or not. | Posted | Count of Participants | Participants | Baseline to 12 Weeks |
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6 weeks
Although All Cause Mortality was collected, serious adverse events were only collected when possibly/probably related to research participation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG001 | 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 | 1 | 82 | 0 | 82 | 0 | 82 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Pratt, PhD-Contact PI | Dartmouth-Hitchcock | 603-496-2665 | sarah.i.pratt@dartmouth.edu |
| Aug 11, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002908 | Chronic Disease |
| D000092862 | Psychological Well-Being |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| >=65 years |
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| Female |
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| Transgender/Other |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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