Personalized Cardiovascular Risk Information to Initiate and Maintain Health Behavior Changes

NCT01134458 | Completed

• 2 other identifiers: Pro00024341FIMDM Research Grant 0170-1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose an evaluation that will assess three important components of risk communication:

1. 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. 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. 3.evaluate how this feedback can be incorporated into clinical care by examining 3 month patient outcome and provider responses to the risk information.

Conditions

Cardiovascular Disease; Peripheral Artery Disease; Ischemic Stroke; Diabetes

Keywords

cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Disease (CVD) Risk Knowledge Assessment

  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.

  Baseline and 3 month @ study end

Study Arms (2)

Control

NO INTERVENTION

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.

Web-based Intervention

EXPERIMENTAL

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

Interventions

Web-Based Intervention BEHAVIORAL

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

Also known as: Health Dialog Cardiac Risk Calculator

Web-based Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Peripheral Arterial Disease; Ischemic Stroke; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hayden Bosworth, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

US (1)