Cardiovascular Health Program Registry

Terminated

• Conditions: Cardiovascular Disease

• Registration Number: NCT01975181
• Lead Sponsor: Walter Reed National Military Medical Center

Brief Summary

The purpose of this study is to establish a registry that uses observational study methods to collect uniform data (clinical, lifestyle and other) to evaluate specific outcomes and to enable research on patients at risk for cardiovascular disease (CVD).

This is a descriptive, observational registry study. All data for participants in the WRNMMC Integrative Cardiac Health Project (ICHP) Cardiovascular Health Program (CHP) will be entered into a single, secure information management system (IMS) for subjects at risk for CVD. At periodical intervals, the IMS will be queried to define the effect of an integrative therapeutic lifestyle change (TLC) program on CVD risk over time. This protocol outlines collection, storage, and handling of data, describes specific data elements and lays the foundation for future research questions.

Detailed Description

The CHP registry consists of uniform data to evaluate the outcomes of military beneficiaries at CVD risk. These uniform data include variables (clinical, lifestyle, traditional, non-traditional, objective and subjective) that are used to assess a CVD risk profile and the effects of TLC. All data are collected in the course of the clinical CHP.

Data are comprised of demographic information; past and intercurrent medical history including risk factors of CVD such as coronary artery disease (CAD), carotid disease, peripheral arterial disease, aortic aneurysm hypertension, diabetes and sleep apnea; smoking, alcohol and drug use history; family history of CVD and other chronic diseases; deployment history, injuries and occupational exposures; mental health history including PTSD, depression and anxiety; lifestyle information comprised of self-reported dietary patterns, exercise activities, stress levels, and sleep habits; physical examination including vital signs, body mass index, waist circumference and per cent body fat; laboratory data routinely requested by the CHP for risk assessment of all patients entering the program is comprised of total cholesterol, cholesterol fractions, fasting glucose, fasting insulin, hemoglobin A1C, highly sensitive C-reactive protein, and vitamin D levels; and CV diagnostic tests such as EKG, echocardiogram, cardiac stress testing; and sleep testing.

Data are measured at baseline (CHP enrollment), completion of onsite CHP (6 months) and after follow-up of the telephonic coaching phase (approximately 1 year). Data may also be collected annually for up to 5 years if available.

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Study Start: 2014-12
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Status Verified: 2018-09
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1164

Inclusion Criteria

1. Any adult military, DEERS eligible, beneficiary who is participating in the CHP.
2. Subjects who present to the CHP for evaluation and participation may be self-referred or be referred by a provider.
3. Must have working email address and access to the internet.
4. Participants elect to enroll in order to learn about healthy lifestyle choices that can help prevent the development of cardiovascular disease.

Exclusion Criteria

1. Less than 18 years of age.
2. Individuals unable or unwilling to participate or give informed consent will be excluded from registry enrollment.
3. Subjects who were part of the retrospective CHP cohort cannot be enrolled in the prospective study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Cardiovascular Risk Score	8 months	A cardiovascular risk score is calculated using the Framingham Risk Score PLUS other factors including family history, body mass index, diastolic blood pressure, high sensitivity C-reactive protein, low-density lipoprotein, triglyceride and lipoprotein (a).

Secondary Outcome Measures

Name	Time	Method
Improvement in Dietary Score using the Rate-Your Plate Dietary Assessment Tool	8 months	Specific dietary behaviors are surveyed using the Rate-Your-Plate Dietary Assessment Tool with scores for each behavior ranging from 0 to 3. A high score indicates a health dietary behavior. All individual scores are added to calculate an overall score for healthy eating.
Improvement in Perceived Stress Scale	8 months	Using the Perceived Stress Scale, subjects report on subjectively experienced stress levels over the several weeks prior to the measurement date.
Improvement in Exercise	8 months	For exercise evaluation, questions concerning amounts of intentional exercise performed in at least 10 minute blocks will determine the activity levels individual patients are performing regularly.
Improvement in Pittsburgh Sleep Quality Index (PSQI)	8 months	Subjects complete the questionnaire (PSQI) to have a global assessment of their sleep quality for the time period including a month before the questionnaire completion.

Trial Locations

Locations (1)

Integrative Cardiac Health Project, Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States