Comparative Effectiveness of IIMR Versus CDSMP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Integrated Illness Management and Recovery
BehavioralEducation and skills training groups on illness management of chronic medical and psychiatric illness.
Chronic Disease Self-Management Program
BehavioralEducation and skills training groups on illness management of chronic conditions
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Integrated Illness Management and Recovery (I-IMR):Experimental treatment 1 intervention
Group B: Stanford Chronic Disease Self-Management Program (CDSMP):Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from Baseline to 12 months2
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.
Time frame
Change from Baseline to 12 months3
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.
Time frame
Change from Baseline to 12 months4
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.
Time frame
Change from Baseline to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dartmouth-Hitchcock Medical Center
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov