Cardiovascular Health Program Registry

NCT01975181 | Terminated

• 1 other identifier: 372910
• Study Type: observational
• Target: 1,164
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

cardiovascular health; lifestyle modification; patient reported outcomes; risk assessment

Outcome Measures

Primary Outcomes (1)

• Improvement in Cardiovascular Risk Score

  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).

  8 months

Secondary Outcomes (4)

• Improvement in Dietary Score using the Rate-Your Plate Dietary Assessment Tool

  8 months

• Improvement in Exercise

  8 months

• Improvement in Perceived Stress Scale

  8 months

• Improvement in Pittsburgh Sleep Quality Index (PSQI)

  8 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 5000, male and female, adult military health care beneficiaries (active duty, dependents, and retired) who are at risk for CVD and who attend the CHP at WRNMMC will be asked to join the CHP registry. There will be no biased selection based on gender, age, racial or ethnic origin. A majority of participants are free of cardiovascular symptoms. Participants elect to enroll in order to learn about healthy lifestyle choices that can help prevent the development of cardiovascular disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator

Study Sites (1)

Integrative Cardiac Health Project, Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (2)

• 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.

  PMID: 24633816 RESULT

• 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.

  PMID: 27157185 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Todd C Villines, MD

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: December 1, 2014
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: April 2, 2019

Record last verified: 2018-09

Locations

US (1)