Chronic Disease Clinical Trial
Official title:
Comparative Effectiveness of Integrated Illness Management and Recovery Versus the Chronic Disease Self-Management Program
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | January 2027 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Seven Counties Services | Louisville | Kentucky |
United States | Centerstone | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Dartmouth-Hitchcock Medical Center | Patient-Centered Outcomes Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 from Baseline to 12 months | |
Primary | 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 from Baseline to 12 months | |
Primary | 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. | Change from Baseline to 12 months | |
Primary | 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. | Change from Baseline to 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Recruiting |
NCT06058754 -
Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial)
|
N/A | |
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Recruiting |
NCT05558085 -
Biomarker Cost-Benefit Analysis of EFNEP
|
N/A | |
Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
Not yet recruiting |
NCT05622422 -
A Chronic Disease Self Care Management Pilot Study
|
N/A | |
Not yet recruiting |
NCT06016101 -
Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
|
||
Not yet recruiting |
NCT04954209 -
Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs
|
||
Not yet recruiting |
NCT04090593 -
Chronic Disease Mobile Educational Experience
|
N/A | |
Not yet recruiting |
NCT03628963 -
Optimizing Patient Usability Experience for Chronic Care
|
N/A | |
Completed |
NCT02390570 -
Incorporating Patient Capacity Into the Clinical Landscape
|
N/A | |
Completed |
NCT02072941 -
Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)
|
N/A | |
Completed |
NCT02292940 -
Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
|
||
Terminated |
NCT02115971 -
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
|
N/A | |
Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
Completed |
NCT02017262 -
Group Self-Management of Depression and Medical Illness
|
N/A | |
Completed |
NCT02307929 -
Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA
|
N/A | |
Completed |
NCT01458184 -
Study of PhoneCare System to Treat Patients With Chronic Diseases
|
N/A | |
Completed |
NCT00333710 -
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
|
N/A | |
Completed |
NCT00380536 -
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
|
N/A |