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Completed

NCT Number: NCT02127671

Intervention Trial to Decrease Cardiovascular Risk 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.

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Key information

Conditions

Cardiovascular Risk Factors Serious Mental Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins ProHealth Clinical Research Facility

Woodlawn, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IDEAL intervention

Other

Control

Other

Primary outcomes

  1. Global Framingham Risk Score

    Time frame: Baseline, 18 months

    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

Secondary outcomes

  1. Weight in Pounds

    Time frame: Baseline, 6 and 18 months

    Weight measured in pounds.

  2. Body Mass Index (BMI)

    Time frame: baseline and 18 months

    Body mass index measured in kg/meter2

  3. Distance Traveled in the 6 Minute Walk Test

    Time frame: Baseline, 6 and 18 months

    6 minute walk test measured in feet. More feet traveled indicates better results.

  4. Healthy Diet as Indicated by Sugar Sweetened Beverage Consumption

    Time frame: Baseline, 6 and 18 months

    Self reported number of sugar sweetened beverages consumed per week on average. A higher score indicated a greater number of sugar sweetened beverages consumed.

  5. Healthy Diet as Indicated by Fast Food Consumption

    Time frame: baseline, 6 and 18 months

    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.

  6. Fasting Glucose Level

    Time frame: baseline and 18 months

    Fasting glucose level reported in mg/dl.

  7. Participants With Diabetes Mellitus Treated to Goal (HgBA1c)

    Time frame: Baseline, 6 and 18 months

    A1c Goal used for analysis was <7.

  8. Current Smoking Status

    Time frame: Baseline and 18 months

    Self reported smoking status for clients with the data below reflecting the number of clients who reported currently smoking at that time point.

  9. Blood Pressure

    Time frame: baseline and 18 months

    Systolic and diastolic blood pressure measured in mmhg

  10. Participants With Hypertension Treated to Goal

    Time frame: Baseline, 6 and 18 months

    Hypertension goal used for analysis was systolic blood pressure <140 and diastolic blood pressure <90. not modeled

  11. Total Cholesterol

    Time frame: Baseline and 18 months

    Total cholesterol measured in mg/dl

  12. LDL Cholesterol

    Time frame: Baseline and 18 months

    LDL cholesterol measured in mg/dl

  13. HDL Cholesterol

    Time frame: Baseline and 18 months

    HDL cholesterol measured in mg/dl

  14. Triglycerides

    Time frame: Baseline and 18 months

    Triglycerides measured in mg/dl

  15. Participants With Dyslipidemia Treated to Goal

    Time frame: Baseline, 6 and 18 months

    Goal used for analysis was LDL cholesterol < 130 mg/dl and Total cholesterol < 200mg/dl.

Other outcomes

  1. Health Status With Short Form (SF)-12

    Time frame: Baseline, 6 and 18 months

    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.

  2. Quality of Life Based on the EUROQOL

    Time frame: Baseline, 6 and 18 months

    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.

  3. Medication Adherence

    Time frame: Baseline, 6 and 18 months

    Used medication adherence measure designed by Morisky et al and separately evaluated somatic and psychiatric medications.

  4. Medication Use for Cardiovascular Risk Factors

    Time frame: Baseline, 6 and 18 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: IDEAL

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 1, 2014
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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