Clinical trial NCT02127671: Intervention Trial to Decrease Cardiovascular Risk in Persons With Serious Mental Illness
Official title: Comprehensive Cardiovascular Diseases (CVD) Risk Reduction Trial in Persons With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Serious Mental Illness
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-05-01
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: global Framingham Risk Score
timeFrame: 18 months
Secondary outcomes:
measure: weight
timeFrame: 6 and 18 months
measure: BMI
timeFrame: 6 and 18 months
measure: 6 minute walk test
timeFrame: 6 and 18 months
measure: healthy diet
timeFrame: 6 and 18 months
measure: fasting glucose level
timeFrame: 6 and 18 months
measure: diabetes mellitus treated to goal (HgBA1c)
timeFrame: 6 and 18 months
measure: smoking cessation
timeFrame: 6 and 18 months
measure: blood pressure
timeFrame: 6 and 18 months
measure: hypertension treated to goal
timeFrame: 6 and 18 months
measure: total cholesterol
timeFrame: 6 and 18 months
measure: LDL cholesterol
timeFrame: 6 and 18 months
measure: HDL cholesterol
timeFrame: 6 and 18 months
measure: triglycerides
timeFrame: 6 and 18 months
measure: dyslipidemia treated to goal
timeFrame: 6 and 18 months
Other outcomes:
measure: health status with Short Form (SF)-12
timeFrame: 6 and 18 months
measure: quality of life
timeFrame: 6 and 18 months
measure: medication adherence
timeFrame: 6 and 18 months
measure: medication use for cardiovascular risk factors
timeFrame: 6 and 18 months
Locations:
city: Woodlawn
country: United States
facility: Johns Hopkins ProHealth Clinical Research Facility
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail L. Daumit, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
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.