Cardiovascular DiseaseNCT01975181
Cardiovascular Health Program Registry
An observational study of Cardiovascular Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 1,164 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 24 Aug 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
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.
Read the 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
- Keywords
- cardiovascular health, lifestyle modification, patient reported outcomes, risk assessment
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 months
Secondary outcomes (4)
Improvement in Dietary Score using the Rate-Your Plate Dietary Assessment Tool
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.
Measured: 8 months
Improvement in Exercise
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.
Measured: 8 months
Improvement in Perceived Stress Scale
Using the Perceived Stress Scale, subjects report on subjectively experienced stress levels over the several weeks prior to the measurement date.
Measured: 8 months
Improvement in Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startDec 2014
- Primary completion24 Aug 2017
- Study completion24 Aug 2017
Why it stopped: No funding - program closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,164 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Todd C Villines, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975181
- Sponsor's protocol ID
- 372910
- Status last verified
- Sep 2018
- First submitted
- 28 Oct 2013
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24633816Kashani 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.
PubMed 27157185
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Program Registry
- ClinicalTrials.gov ID
- NCT01975181
- Acronym / sponsor ID
- 372910
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular health, lifestyle modification, patient reported outcomes, risk assessment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No funding - program closure
- Enrolment
- 1,164 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- Dec 2014 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Improvement in Dietary Score using the Rate-Your Plate Dietary Assessment Tool
Time frame: 8 months
Improvement in Exercise
Time frame: 8 months
Improvement in Perceived Stress Scale
Time frame: 8 months
Improvement in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 months
Results and safety
The study was stopped early (reason given: No funding - program closure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Results publication: PubMed 24633816Eliasson 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.
- Results publication: PubMed 27157185Kashani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd C Villines, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No funding - program closure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Cardiovascular Risk Score (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01975181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.