NCT02127671

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Risk Factors
• Serious Mental Illness

Interventions

Type	Name	Description
OTHER	IDEAL intervention
OTHER	Control

Timeline

• Start date: 2013-12-12
• Primary completion: 2018-11-16
• Completion: 2018-11-16
• First posted: 2014-05-01
• Last updated: 2025-08-11
• Results posted: 2025-08-11

Locations

1 site across 1 country: United States