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Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01134458
Acronym
FIMDM_CVD
Enrollment
98
Registered
2010-06-02
Start date
2010-12-31
Completion date
2014-02-28
Last updated
2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Diabetes, Ischemic Stroke, Peripheral Artery Disease

Keywords

cardiovascular disease

Brief summary

The investigators propose an evaluation that will assess three important components of risk communication: 1. provide patients with personalized risk communication using the risk calculator developed by FIMDM and health information taken from the Living with Coronary Artery Disease program 2. provide personalized tailored patient feedback to help initiate and maintain specific cardiovascular CVD-related behaviors(e.g., medication adherence, exercise, diet, smoking cessation) to reduce their risks. 3. evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

Detailed description

Patients at high risk for CVD events frequently underestimate their risk. Programs to improve CVD outcomes have largely focused on single risk factors and do not contextualize the information with a patient's global risk. An easy, accessible strategy to address global CVD risk based on personalized risk communication feedback with assistance with initiating and maintaining health behaviors has several advantages, but has not formally been tested. A patient's perceived risk of stroke or heart attack is an important factor in understanding motivation for risk reducing behaviors. Lower perceived risk has been associated with poorer adherence to recommended health behaviors. Additionally, a person's beliefs about his or her risk for a disease increased the likelihood of a more informed and activated patient, and figures prominently in models of health behavior (e.g., Health Belief Model). People tend to underestimate their own risk; Therefore providing accurate risk communication has the potential to activate patients to initiate and maintain behavior changes.

Interventions

1. Health Dialog Cardiac Risk Calculator 2. Health Dialog's Living with Coronary Heart Disease 3. Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* cardiovascular disease (CVD) * CVD risk equivalent (peripheral arterial disease, history of ischemic stroke, or diabetes)

Exclusion criteria

* metastatic cancer, * dementia, * active psychosis * end-stage renal disease * no access to computer with Internet

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular Disease (CVD) Risk Knowledge AssessmentBaseline and 3 month @ study endTrained personnel will obtain the patients' outcome values (i.e., weight, height, BP) at baseline and subsequent 3-month outcome using a digital sphygmomanometer and digital scale according to a standard protocol. The baseline interview includes demographics and an assessment of patients' health behavior, perceived risk, and interactions with their provider. At 3-month follow-up visit, patients will also undergo an in-person interview to determine changes in weight, smoking status, medication adherence, decisional conflict, knowledge.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026