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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02127671
Other study ID # NA_00072197
Secondary ID R01HL112299
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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