Cardiovascular Health Program Registry

NCT ID: NCT01975181

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-08-24

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.

Conditions

Cardiovascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: collaborator

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd C Villines, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Integrative Cardiac Health Project, Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

References

Eliasson AH, Kashani MD, Howard RS, Vernalis MN, Modlin RE; Integrative Cardiac Health Project Registry. Fatigued on Venus, sleepy on Mars-gender and racial differences in symptoms of sleep apnea. Sleep Breath. 2015 Mar;19(1):99-107. doi: 10.1007/s11325-014-0968-y. Epub 2014 Mar 15.

Reference Type: RESULT

PMID: 24633816 (View on PubMed)

Kashani M, Eliasson AH, Walizer EM, Fuller CE, Engler RJ, Villines TC, Vernalis MN. Early Empowerment Strategies Boost Self-Efficacy to Improve Cardiovascular Health Behaviors. Glob J Health Sci. 2016 Sep 1;8(9):55119. doi: 10.5539/gjhs.v8n9p322.

Reference Type: RESULT

PMID: 27157185 (View on PubMed)

Other Identifiers

372910

Identifier Type: -

Identifier Source: org_study_id