Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness (IDEAL)

Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness

This study will determine whether a program where a health coach works with participants on heart healthy behaviors and treatment of risk factors is coordinated with primary care can reduce overall heart disease risk in people with serious mental illness.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factors; Serious Mental Illness
• Intervention / Treatment: Other: Control; Other: IDEAL intervention

Detailed Description

The objective of this study is to perform a randomized clinical trial (IDEAL) to test a comprehensive cardiovascular risk reduction program for persons with serious mental illness. This trial will enroll adult mental health consumers with at least one cardiovascular risk factor and randomize them to the 18-month IDEAL intervention or control. Intervention participants will receive individual cardiovascular risk reduction counseling, coordination with primary care providers to ensure appropriate management of risk factors, and collaboration with mental health staff and social supports to encourage and motivate participants to reach goals. All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals. The primary outcome will be the change in estimated cardiovascular risk from the global Framingham Risk Score.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Woodlawn, Maryland, United States
      • Johns Hopkins ProHealth Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ▪ Age 18 and older

  ▪ Body mass index at least 25 kg/m2 OR one of the following CVD risk factors:

• Hypertension (SBP>= 140mmHg or DBP>= 90mmHg or on antihypertensive medications;
• Diabetes mellitus (fasting blood sugar> 125mg/dl or hemoglobin A1c>6.5 or on a hypoglycemic medication);
• Dyslipidemia (LDL >130 mg/dl , HDL<40 or total cholesterol >=200 or on a lipid lowering agent);

• Current tobacco smoker

  • Able and willing to give informed consent
  • Completion of baseline data collection
  • Willing to accept randomization
  • Willing to participate in the intervention

Exclusion Criteria:

• ▪ Cardiovascular event (unstable angina, myocardial infarction) within the past 6 months

  • Serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
  • Condition which interferes with outcome measurement (e.g., dialysis)
  • Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician.
  • Alcohol or substance use disorder if not sober/abstinent for 30 days
  • Planning to leave rehabilitation center or clinic within 6 months or move out of geographic area within 18 months
  • Investigator judgment (e.g., for concerns about participant or staff safety)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDEAL intervention; Individual cardiovascular risk reduction counseling, coordination with primary care providers to ensure appropriate management of risk factors, and collaboration with mental health staff and social supports. All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.	Other: IDEAL intervention
Other: Control; All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.	Other: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Framingham Risk Score	Global Framingham Cardiovascular disease Risk Score. Higher score indicates higher cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke	Baseline, 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in Pounds	Weight measured in pounds.	Baseline, 6 and 18 months
Body Mass Index (BMI)	Body mass index measured in kg/meter2	baseline and 18 months
Distance Traveled in the 6 Minute Walk Test	6 minute walk test measured in feet. More feet traveled indicates better results.	Baseline, 6 and 18 months
Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption	Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed.	Baseline, 6 and 18 months
Healthy Diet as Indicated by Fast Food Consumption	Self reported number of times eating at a fast food restaurant per month on average. A higher score indicates a greater frequency of eating fast food.	baseline, 6 and 18 months
Fasting Glucose Level	Fasting glucose level reported in mg/dl.	baseline and 18 months
Participants With Diabetes Mellitus Treated to Goal (HgBA1c)	A1c Goal used for analysis was <7.	Baseline, 6 and 18 months
Current Smoking Status	Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point.	Baseline and 18 months
Blood Pressure	Systolic and diastolic blood pressure measured in mmhg	baseline and 18 months
Participants With Hypertension Treated to Goal	Hypertension goal used for analysis was systolic blood pressure <140 and diastolic blood pressure <90. not modeled	Baseline, 6 and 18 months
Total Cholesterol	Total cholesterol measured in mg/dl	Baseline and 18 months
LDL Cholesterol	LDL cholesterol measured in mg/dl	Baseline and 18 months
HDL Cholesterol	HDL cholesterol measured in mg/dl	Baseline and 18 months
Triglycerides	Triglycerides measured in mg/dl	Baseline and 18 months
Participants With Dyslipidemia Treated to Goal	Goal used for analysis was LDL cholesterol < 130 mg/dl and Total cholesterol < 200mg/dl.	Baseline, 6 and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Status With Short Form (SF)-12	Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Both subscale score ranges are 0-100. Higher scores indicate better physical or mental health.	Baseline, 6 and 18 months
Quality of Life Based on the EUROQOL	Self reported measured by the EUROQOL EQ-5D-3L. A higher score indicates better health and a lower score indicates worse health; on a scale of 0 to 1. Not modeled.	Baseline, 6 and 18 months
Medication Adherence	Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications.	Baseline, 6 and 18 months
Medication Use for Cardiovascular Risk Factors	Medications as reported by participant and then categorized by research study nurse into hypertension, diabetes, dyslipidemia and smoking cessation. Will report the number of participants taking at least one medication in each category of those with the specified condition at baseline.	Baseline, 6 and 18 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gail L. Daumit, MD, MHS, Johns Hopkins University

Publications and helpful links

General Publications

• Daumit GL, Dalcin AT, Dickerson FB, Miller ER, Evins AE, Cather C, Jerome GJ, Young DR, Charleston JB, Gennusa JV 3rd, Goldsholl S, Cook C, Heller A, McGinty EE, Crum RM, Appel LJ, Wang NY. Effect of a Comprehensive Cardiovascular Risk Reduction Intervention in Persons With Serious Mental Illness: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e207247. doi: 10.1001/jamanetworkopen.2020.7247.

Study record dates

Study Major Dates

• Study Start: December 12, 2013
• Primary Completion (Actual): November 16, 2018
• Study Completion (Actual): November 16, 2018

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimated): May 1, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: NA_00072197; R01HL112299 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No