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Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk

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ClinicalTrials.gov Identifier: NCT01245686
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Thomas Keyserling, MD, MPH, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 22, 2010
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE February 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
Predicted 10-year CHD risk [ Time Frame: 4-month follow-up ]
Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period. We will examine absolute changes in this outcome in both intervention arms. We will also examine whether this outcome varies by subgroups of the following variables: baseline level of predicted CHD risk, age, race, SES, insurance status, overall health status, numeracy, literacy, # medications, # of perceived barriers to adherence, use of the intervention, time with the intervention, study practice site, and health counselor
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
Predicted 10-year CHD risk [ Time Frame: 4-month follow-up ]
Framingham risk scores are based on prospectively collected data from men and women aged 30-79, are well-validated, and provide an absolute measure of the likelihood of CHD events (angina, MI, and CHD death) over a defined period of time (usually 10 years).
Change History Complete list of historical versions of study NCT01245686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2011)
  • Predicted 10-year CHD risk [ Time Frame: 12 months ]
    Framingham risk scores are well-validated and provide an absolute estimate of the likelihood of CHD events (MI, angina, and CHD death) over a 10-year time period.
  • Use of and adherence to cardiovascular medicines [ Time Frame: 4 and 12 months ]
    Use of cardiovascular medicines will be by self-report. Adherence to cardiovascular medicines will be measured by the 8-Item Morisky scale and a single-item specifying overall percentage adherence to cardiovascular medicines(categorical). Participants will additionally report use of and adherence to individual medicines, including aspirin, blood pressure medicine, and cholesterol medicine. Aspirin adherence will be validated by serum thromboxane b2 in a subsample of participants. Blood pressure and cholesterol medicine use will be confirmed by changes in blood pressure and cholesterol.
  • Dietary Intake [ Time Frame: 4 and 12 months ]
    Dietary intake will be measured through a combination of self-report and objective measures. Participants will self-report diet on two validated questionnaires: the block questionnaire (fruit and vegetable intake) and the fat quality screener. Fruit and vegetable intake will be objectively measured by serum carotenoids. Fat quality will be objectively measured using RBC membrane fatty acids.
  • Physical activity [ Time Frame: 4 and 12 months ]
    Physical activity will be measured through a combination of self-report and objective measures. Participants will report physical activity on the validated modified RESIDE questionnaire. They will additionally wear a pedometer to monitor their daily total and aerobic steps.
  • Blood pressure [ Time Frame: 4 and 12 months ]
    Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor
  • Total, HDL, and direct LDL cholesterol [ Time Frame: 4 and 12 months ]
    Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.
  • Smoking status [ Time Frame: 4 and 12 months ]
    Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).
  • Adverse events [ Time Frame: 4 and 12 months ]
    We will monitor the following adverse events: ED visits (self-report), hospitalizations (self-report), deaths (family report confirmed by death registry), GI bleeds (self-report), hemorrhagic stroke (self-report), musculoskeletal injury (self-report), renal dysfunction (serum creatinine), and liver dysfunction (AST).
  • Acceptability of the Intervention [ Time Frame: 4 and 12 months ]
    We will measure the acceptability of the intervention using process measures querying participants, office staff, and clinicians about the perceptions of the acceptability of the intervention and the time to deliver it.
  • Cost-effectiveness [ Time Frame: 4 and 12 months ]
    We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heart to Health: A Combined Lifestyle and Medication Intervention to Reduce Cardiovascular Disease (CVD) Risk
Official Title  ICMJE A Combined Lifestyle and Medication Intervention to Reduce CVD Risk
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Coronary Heart Disease
Intervention  ICMJE Behavioral: Lifestyle and medication intervention
The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence). The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
Study Arms  ICMJE
  • Active Comparator: One-on-one counseling
    Participants in this arm will receive 4 intensive one-on-one counseling sessions (either in person or on the phone) and 3 brief maintenance sessions.
    Intervention: Behavioral: Lifestyle and medication intervention
  • Active Comparator: Web counseling
    Participants in this arm will receive 4 intensive counseling sessions over the web. They will also receive 3 maintenance sessions over the web.
    Intervention: Behavioral: Lifestyle and medication intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2013)
489
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2010)
600
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Established patients
  • Men ages 35-79
  • Women ages 45-79
  • History of CVD (100 participants)
  • CHD risk equal or greater than 10%
  • elevated CHD risk factor

Exclusion Criteria:

  • non-English speaking
  • no phone
  • treatment of psychosis
  • history of alcohol/substance abuse within last 2 years
  • pregnancy, breast feeding, or anticipated pregnancy in next 18 months
  • history of malignancy, other than non-melanoma skin cancer, that has not been in remission or cured surgically for >5 years
  • recent history (in past year) of hypoglycemic event requiring medical attention
  • estimated creatinine clearance less than 30 ml/min
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01245686
Other Study ID Numbers  ICMJE 10-2028
1U48DP002658 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Keyserling, MD, MPH, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Thomas C Keyserling, MD, MPH UNC-Chapel Hill
Study Director: Stacey L Sheridan, MD, MPH UNC-Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP