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

Johns Hopkins University

Status: Completed

Conditions: Serious Mental Illness; Cardiovascular Risk Factors

Treatments: Other: Control; Other: IDEAL intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02127671

NA_00072197

R01HL112299 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

269 participants in 2 patient groups

IDEAL intervention

Experimental group

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.

Treatment:

Other: IDEAL intervention

Control

Other group

Description:

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

Treatment:

Other: Control