Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions

NCT05467982 | Completed Results DMC

• 1 other identifier: STUDY00031245
• Study Type: interventional
• Target: 164
• 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. In addition, PCORI is funding an evaluation of a COVID-related intervention that will begin in the Fall 2020.

Conditions

Mental Illness; Chronic Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Behavioral: Integrated Illness Management and Recovery

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)

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. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.

Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:

Chronic Disease Self-Management Program BEHAVIORAL

Education and skills training groups on illness management of chronic conditions

Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:

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 (NCT03966872).

Sponsors & Collaborators

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

Study Sites (2)

Seven Counties Services

Louisville, Kentucky, 40220, United States

Location

Centerstone

Nashville, Tennessee, 37228, United States

Location

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

Results Point of Contact

• Title: Sarah Pratt, PhD-Contact PI
• Organization: Dartmouth-Hitchcock

sarah.i.pratt@dartmouth.edu

603-496-2665

Study Officials

• Sarah Pratt, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: July 19, 2022
• First Posted: July 21, 2022
• Study Start: October 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)