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NCT01245686 · ClinicalTrials.gov registry record · NA
Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
A NA study of Cardiovascular Disease and Coronary Heart Disease, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 489
- Enrollment target
- 5
- Study locations
NCT01245686 is a NA study of Cardiovascular Disease and Coronary Heart Disease that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 489 participants, below the 2,710-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (82% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT01245686, a NA study of Cardiovascular Disease and Coronary Heart Disease, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 489 participants
- Enrollment target
- 5
- Study locations
Study Summary
Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health care and lost productivity. Both lifestyle changes and medication can reduce the risk of CVD, and this project combines these approaches in the hopes of identifying a practical intervention for use in primary care medical offices. The project combines two previously tested interventions and updates them to meet current guidelines for diet and use of aspirin and cholesterol-controlling drugs (statins). The research team is delivering the combined intervention in two formats: web-based and counselor-based. Each format has the same content, but the web-based advice is accessed through the Internet by clients at home, a community site, or a primary care office. The other format involves sessions delivered to clients by a counselor either in person at a primary care office or over the telephone. The researchers will compare how effective each format is in reducing participants' risk of coronary heart disease. They will also determine the interventions' effect on participants' diet, physical activity, smoking status, medication adherence, and other health indicators. In addition, the team will compare the two formats' cost-effectiveness and how well the patients, office staff, and clinicians accept the interventions. Recruited from five family practices, 600 patients representing the geographic and ethnic diversity of North Carolina are taking part in this study. Half the participants are randomly assigned to the web-based intervention; the other half to the counselor-based version. Both groups will also get information on local resources, such as gyms and farmers markets, that can help participants maintain a healthy lifestyle.
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle and medication intervention
Study Locations (5)
North Carolina
- Durham Family Practice - Durham
- Dayspring Family Medicine - Eden
- Cabarrus Family Medicine Residency - Kannapolis
- Moncure Community Health Center - Moncure
- Caswell Family Medical Clinic - Yanceyville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 489 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01245686
The ClinicalTrials.gov registry entry for NCT01245686 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 489 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,710-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (82% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Lifestyle and medication intervention is the first listed.
NCT01245686 reports 5 study locations spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01245686 about?
NCT01245686 is a clinical study titled "Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk". Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the US. Every year, more than one million Americans have a heart attack, and nearly 800,000 have a stroke. In 2010, heart disease alone is expected to cost the country more than $316 billion in health ...
What is the current status of trial NCT01245686?
This trial is currently completed. It is a NA study. The enrollment target is 489 participants. The study started on 2011-02. Estimated completion is 2012-11.
What conditions does trial NCT01245686 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Coronary Heart Disease.
What interventions are being tested in trial NCT01245686?
The interventions under investigation include: Lifestyle and medication intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01245686?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01245686 being conducted?
This trial has 5 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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