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

Primary Purpose

Cardiovascular Risk Factors, Serious Mental Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IDEAL intervention
Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Risk Factors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Johns Hopkins ProHealth Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

IDEAL intervention

Control

Arm Description

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.

All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.

Outcomes

Primary Outcome Measures

global Framingham Risk Score

Secondary Outcome Measures

weight
BMI
6 minute walk test
healthy diet
fasting glucose level
diabetes mellitus treated to goal (HgBA1c)
smoking cessation
blood pressure
hypertension treated to goal
total cholesterol
LDL cholesterol
HDL cholesterol
triglycerides
dyslipidemia treated to goal

Full Information

First Posted
April 29, 2014
Last Updated
January 16, 2019
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02127671
Brief Title
Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness
Acronym
IDEAL
Official Title
Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 12, 2013 (undefined)
Primary Completion Date
November 16, 2018 (Actual)
Study Completion Date
November 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Risk Factors, Serious Mental Illness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IDEAL intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.
Intervention Type
Other
Intervention Name(s)
IDEAL intervention
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
global Framingham Risk Score
Time Frame
18 months
Secondary Outcome Measure Information:
Title
weight
Time Frame
6 and 18 months
Title
BMI
Time Frame
6 and 18 months
Title
6 minute walk test
Time Frame
6 and 18 months
Title
healthy diet
Time Frame
6 and 18 months
Title
fasting glucose level
Time Frame
6 and 18 months
Title
diabetes mellitus treated to goal (HgBA1c)
Time Frame
6 and 18 months
Title
smoking cessation
Time Frame
6 and 18 months
Title
blood pressure
Time Frame
6 and 18 months
Title
hypertension treated to goal
Time Frame
6 and 18 months
Title
total cholesterol
Time Frame
6 and 18 months
Title
LDL cholesterol
Time Frame
6 and 18 months
Title
HDL cholesterol
Time Frame
6 and 18 months
Title
triglycerides
Time Frame
6 and 18 months
Title
dyslipidemia treated to goal
Time Frame
6 and 18 months
Other Pre-specified Outcome Measures:
Title
health status with Short Form (SF)-12
Time Frame
6 and 18 months
Title
quality of life
Time Frame
6 and 18 months
Title
medication adherence
Time Frame
6 and 18 months
Title
medication use for cardiovascular risk factors
Time Frame
6 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L. Daumit, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins ProHealth Clinical Research Facility
City
Woodlawn
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32530472
Citation
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.
Results Reference
derived

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

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