FIMDM_CVD: Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT01134458
Collaborator
(none)
98
1
2
38
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web-Based Intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes
Study Start Date :
Dec 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Receive primary care and management of CVD according to the discretion of their primary care provider. They will also receive generic educational information concerning CVD at baseline and at study end (at their request). We will collect outcomes at baseline and 3-months.

Experimental: Web-based Intervention

Given current risk assessment for CVD based on Health Dialog Cardiac Risk Calculator, recommendations for behavior change, and Health Dialog's Living with Coronary Heart Disease. Can change initial patient risk information provided by the Risk Calculator during the initial visit, noting what they are will work on during the study. Sent monthly email reminders to log onto the system to choose that months' behavioral modules. Given a choice of at least 2 health behavior modules per month (smoking cessation, exercise, diet, and weight) to improve their CVD risk. Information on risk, CVD knowledge, medication management and side effects will be provided to all participants. It will also provide tailored information to help the individual initiate and maintain these behaviors.

Behavioral: Web-Based Intervention
Health Dialog Cardiac Risk Calculator Health Dialog's Living with Coronary Heart Disease Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight
Other Names:
  • Health Dialog Cardiac Risk Calculator
  • Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular Disease (CVD) Risk Knowledge Assessment [Baseline and 3 month @ study end]

      Trained 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Health System Durham North Carolina United States 27705

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Hayden Bosworth, PhD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01134458
    Other Study ID Numbers:
    • Pro00024341
    • FIMDM Research Grant 0170-1
    First Posted:
    Jun 2, 2010
    Last Update Posted:
    Jul 22, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Duke University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2014