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IIMR vs CDSMP for Mental Health Disorders

N/A

Recruiting

Led By Sarah Pratt

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 12 months

Awards & highlights

Study Summary

This trial will compare two different interventions for people with serious mental illness to see which is more effective.

Who is the study for?

This trial is for people with serious mental illnesses like schizophrenia or bipolar disorder, who also have a chronic physical condition such as diabetes or heart disease. They should have had an ER visit or hospitalization in the past year and need help managing their health. It's only for those receiving services at Centerstone in KY or TN and who speak English.Check my eligibility

What is being tested?

The study compares two programs: I-IMR, which helps people with serious mental illness manage both physical and mental health, and CDSMP, focused on managing physical health conditions. The goal is to see which program better supports individuals' self-management of their chronic diseases.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not applicable. However, participants may experience stress or discomfort when discussing personal health issues during the programs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a chronic condition like diabetes or heart disease and was hospitalized or visited the ER last year.

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I have a serious mental illness and am getting help from Centerstone in KY or TN.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Acute Hospital Events from Electronic Medical Record Review.

Change in Knowledge and skills in illness self-management using the Illness Management and Recovery Scale

Change in Patient Activation on the Patient Activation Measure (PAM)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stanford Chronic Disease Self-Management Program (CDSMP):Experimental Treatment1 Intervention

Participants randomly assigned get a 6-session group-based educational program co-delivered by two peers (lay people who have successfully managed a chronic illness) or a peer and a professional

Group II: Integrated Illness Management and Recovery (I-IMR):Experimental Treatment1 Intervention

Participants assigned to I-IMR will receive 2 individual sessions to discuss principles of recovery and set personally meaningful goals, with the remainder of the 14 I-IMR sessions delivered in groups of 8-10 (to enable individual tailoring)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Integrated Illness Management and Recovery

2020

N/A

~170

Chronic Disease Self-Management Program

2017

N/A

~1320

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,542,741 Total Patients Enrolled

4 Trials studying Chronic Disease

1,863 Patients Enrolled for Chronic Disease

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,995,948 Total Patients Enrolled

13 Trials studying Chronic Disease

271,353 Patients Enrolled for Chronic Disease

Sarah PrattPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Chronic Disease Self-Management Program Clinical Trial Eligibility Overview. Trial Name: NCT03966872 — N/A

Chronic Disease Research Study Groups: Integrated Illness Management and Recovery (I-IMR):, Stanford Chronic Disease Self-Management Program (CDSMP):

Chronic Disease Clinical Trial 2023: Chronic Disease Self-Management Program Highlights & Side Effects. Trial Name: NCT03966872 — N/A

Chronic Disease Self-Management Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03966872 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this medical study?

"Correct. Clinicaltrials.gov data confirms that recruitment for this medical study, which was initially posted on September 2nd 2019, is currently being conducted. 600 patients are required to be enrolled from two distinct centres of care."

Answered by AI

Are there still vacancies available for this clinical examination?

"Clinicaltrials.gov confirms that the trial is actively recruiting patients, having been posted on September 2nd 2019 and last updated on December 15th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Effectiveness of IIMR Versus CDSMP

Sarah Pratt 2019. "Comparative Effectiveness of IIMR Versus CDSMP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03966872.

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