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

Cardiovascular Risk Factors Clinical Trial

— IDEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127671
• Other study ID #: NA_00072197
• Secondary ID: R01HL112299
• Status: Completed
• Phase: N/A
• Start date: December 12, 2013
• Est. completion date: November 16, 2018

Study information

• Verified date: January 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Risk Factors
• Mental Disorders
• Serious Mental Illness

Intervention

Other:
• IDEAL intervention

• Control

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth Clinical Research Facility	Woodlawn	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	health status with Short Form (SF)-12		6 and 18 months
Other	quality of life		6 and 18 months
Other	medication adherence		6 and 18 months
Other	medication use for cardiovascular risk factors		6 and 18 months
Primary	global Framingham Risk Score		18 months
Secondary	weight		6 and 18 months
Secondary	BMI		6 and 18 months
Secondary	6 minute walk test		6 and 18 months
Secondary	healthy diet		6 and 18 months
Secondary	fasting glucose level		6 and 18 months
Secondary	diabetes mellitus treated to goal (HgBA1c)		6 and 18 months
Secondary	smoking cessation		6 and 18 months
Secondary	blood pressure		6 and 18 months
Secondary	hypertension treated to goal		6 and 18 months
Secondary	total cholesterol		6 and 18 months
Secondary	LDL cholesterol		6 and 18 months
Secondary	HDL cholesterol		6 and 18 months
Secondary	triglycerides		6 and 18 months
Secondary	dyslipidemia treated to goal		6 and 18 months