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

Not Applicable

Completed

• Conditions: Serious Mental Illness; Cardiovascular Risk Factors
• Interventions: Other: IDEAL intervention; Other: Control

• Registration Number: NCT02127671
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2013-12-12
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Primary Completion: 2018-11-16
• Study Completion: 2018-11-16
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDEAL intervention	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.
Control	Control	All participants will be offered group exercise classes, and programs will be provided with instruction to provide more healthy meals.

Primary Outcome Measures

Name	Time	Method
global Framingham Risk Score	18 months

Secondary Outcome Measures

Name	Time	Method
6 minute walk test	6 and 18 months
healthy diet	6 and 18 months
smoking cessation	6 and 18 months
blood pressure	6 and 18 months
total cholesterol	6 and 18 months
weight	6 and 18 months
BMI	6 and 18 months
HDL cholesterol	6 and 18 months
fasting glucose level	6 and 18 months
diabetes mellitus treated to goal (HgBA1c)	6 and 18 months
hypertension treated to goal	6 and 18 months
LDL cholesterol	6 and 18 months
triglycerides	6 and 18 months
dyslipidemia treated to goal	6 and 18 months

Trial Locations

Locations (1)

Johns Hopkins ProHealth Clinical Research Facility; 🇺🇸 Woodlawn, Maryland, United States