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Cardiovascular DiseaseNCT01245686

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

A study testing Lifestyle and medication intervention in people with Cardiovascular Disease and Coronary Heart Disease, run by University of North Carolina, Chapel Hill at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 79 yearsHealthy volunteers can take part
What is being tested?
Lifestyle and medication intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
489 participants
Where
5 sitesUnited States
Study dates
Feb 2011to Nov 2012
Phase
Interventional
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 35 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Durham Family Practice

    Durham, North Carolina, 27704

  • Dayspring Family Medicine

    Eden, North Carolina, 27288

  • Cabarrus Family Medicine Residency

    Kannapolis, North Carolina, 28081

  • Moncure Community Health Center

    Moncure, North Carolina, 27559

  • Caswell Family Medical Clinic

    Yanceyville, North Carolina, 27379

Other trials in United States

About this study

Official title: A Combined Lifestyle and Medication Intervention to Reduce 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 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).

Read more

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.

Being tested
Lifestyle and medication intervention
Keywords
Diet interventions, Physical activity interventions, Medication adherence, Tailored interventions
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle and medication interventionBehavioural

    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 groups in NCT01245686
Study groupRoleWhat they receive
One-on-one counselingActive comparatorParticipants in this arm will receive 4 intensive one-on-one counseling sessions (either in person or on the phone) and 3 brief maintenance sessions.
Receives: Behavioral: Lifestyle and medication intervention
Web counselingActive comparatorParticipants in this arm will receive 4 intensive counseling sessions over the web. They will also receive 3 maintenance sessions over the web.
Receives: Behavioral: Lifestyle and medication intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predicted 10-year CHD risk

    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

    Measured: 4-month follow-up

Secondary outcomes (10)

  1. Predicted 10-year CHD risk

    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.

    Measured: 12 months

  2. Use of and adherence to cardiovascular medicines

    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.

    Measured: 4 and 12 months

  3. Dietary Intake

    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.

    Measured: 4 and 12 months

  4. Physical activity

    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.

    Measured: 4 and 12 months

  5. Blood pressure

    Blood pressure will be measure via standardized protocol using an oscillometric automatic monitor

    Measured: 4 and 12 months

  6. Total, HDL, and direct LDL cholesterol

    Total, HDL, and direct LDL cholesterol will be measured via enzymatic calorametric testing.

    Measured: 4 and 12 months

  7. Smoking status

    Smoking will be measured through a combination of self-report and urinary cotinine (Nicalert test strips).

    Measured: 4 and 12 months

  8. Adverse events

    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).

    Measured: 4 and 12 months

  9. Acceptability of the Intervention

    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.

    Measured: 4 and 12 months

  10. Cost-effectiveness

    We will measure the cost-unit CHD risk reduction for the two interventions using a societal perspective.

    Measured: 4 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionJul 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245686
Sponsor's protocol ID
10-2028
Other IDs
1U48DP002658
Status last verified
Feb 2013
First submitted
19 Nov 2010
Last updated
6 Feb 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Keyserling TC, Sheridan SL, Draeger LB, Finkelstein EA, Gizlice Z, Kruger E, Johnston LF, Sloane PD, Samuel-Hodge C, Evenson KR, Gross MD, Donahue KE, Pignone MP, Vu MB, Steinbacher EA, Weiner BJ, Bangdiwala SI, Ammerman AS. A comparison of live counseling with a web-based lifestyle and medication intervention to reduce coronary heart disease risk: a randomized clinical trial. JAMA Intern Med. 2014 Jul;174(7):1144-57. doi: 10.1001/jamainternmed.2014.1984.

    PubMed 24861959

  • Sheridan SL, Draeger LB, Pignone MP, Sloane PD, Samuel-Hodge C, Finkelstein EA, Gizlice Z, Vu MB, Gitterman DP, Bangdiwala SI, Donahue KE, Evenson K, Ammerman AS, Keyserling TC. 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. Contemp Clin Trials. 2013 Nov;36(2):394-405. doi: 10.1016/j.cct.2013.07.013. Epub 2013 Aug 2.

    PubMed 23916919

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle and medication intervention in people with Cardiovascular Disease and Coronary Heart Disease, run by University of North Carolina, Chapel Hill at 5 sites 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Predicted 10-year CHD risk (time frame: 4-month follow-up). 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 NCT01245686, 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 6 Feb 2013.

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