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Cardiovascular Health Program Registry

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ClinicalTrials.gov Identifier: NCT01975181
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2013
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
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.


Condition or disease
Cardiovascular Disease

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 Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Cardiovascular Health Program Registry
Actual Study Start Date : December 2014
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024



Primary Outcome Measures :
  1. Improvement in Cardiovascular Risk Score [ Time Frame: 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 :
  1. Improvement in Dietary Score using the Rate-Your Plate Dietary Assessment Tool [ Time Frame: 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.

  2. Improvement in Exercise [ Time Frame: 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.

  3. Improvement in Perceived Stress Scale [ Time Frame: 8 months ]
    Using the Perceived Stress Scale, subjects report on subjectively experienced stress levels over the several weeks prior to the measurement date.

  4. Improvement in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975181


Locations
United States, Maryland
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Walter Reed National Military Medical Center
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
Principal Investigator: Todd C Villines, MD Walter Reed National Military Medical Center

Publications of Results:
Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01975181     History of Changes
Other Study ID Numbers: 372910-6
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018

Keywords provided by Walter Reed National Military Medical Center:
cardiovascular health
lifestyle modification
patient reported outcomes
risk assessment

Additional relevant MeSH terms:
Cardiovascular Diseases