Trial reportContemporary clinical trials2013
Designing and implementing a comparative effectiveness study of two strategies for delivering high quality CHD prevention: methods and participant characteristics for the Heart to Health study.
Trial report in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pooled it
- Risk scoring for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2017Pooled it
- Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study.Journal of cancer survivorship : research and practice · 2021Trial
- Effect of communicating phenotypic and genetic risk of coronary heart disease alongside web-based lifestyle advice: the INFORM Randomised Controlled Trial.Heart (British Cardiac Society) · 2019Trial
- A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers: study protocol.BMC public health · 2018Trial
- A community-based lifestyle and weight loss intervention promoting a Mediterranean-style diet pattern evaluated in the stroke belt of North Carolina: the Heart Healthy Lenoir Project.BMC public health · 2016Trial
- Trial
- A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial.JAMA internal medicine · 2014Trial
- Feasibility and acceptability of a Mediterranean-style diet intervention to reduce cardiovascular risk for low income Hispanic American women.Ethnicity & health · 2019Article
- Explanation and elaboration of the Standards for UNiversal reporting of patient Decision Aid Evaluations (SUNDAE) guidelines: examples of reporting SUNDAE items from patient decision aid evaluation literature.BMJ quality & safety · 2018Article
- Factors Associated With Engagement With a Web-Based Lifestyle Intervention Following Provision of Coronary Heart Disease Risk: Mixed Methods Study.Journal of medical Internet research · 2017Article
- Improving Medication Adherence in Coronary Heart Disease.Current cardiology reports · 2017Review
- The response to receiving phenotypic and genetic coronary heart disease risk scores and lifestyle advice - a qualitative study.BMC public health · 2016Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
Abstract
backgroundAlthough lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial.
methodsWe conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35-79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up.
resultsWe randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African-American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%.
conclusionWe have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.
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