A Personalized Dashboard to Educate Veterans at Risk of Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01133171
First received: May 26, 2010
Last updated: February 6, 2014
Last verified: May 2011
  Purpose

Personalized risk communication methods have been used to educate patients that are at a high risk of developing cardiovascular disease. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to self-manage their risk factors and observe the changes in risk by making lifestyle changes and modifying other risk factors by seeking medical advice.

This Rapid Response Project (RRP) builds upon these methods of communication by presenting the modifiable risk factors in the form of a personalized dashboard that highlights the contribution of these risk factors on the risk of developing a cardiovascular event. The modifiable risk factors that will be addressed in this study will include medical and lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation, diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.

Our primary goal is to develop a prototype of the dashboard to educate patients and help them make informed decisions in modifying their risk factors to reduce the probability of a cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by asking these patients to return after 6 months to determine if they have made any lifestyle changes or pursued medical intervention to reduce their cardiovascular risk. We will make qualitative observations on the knowledge retention of these patients while using the interactive dashboard.


Condition Intervention
Cardiovascular Disease
Stroke
Behavioral: Risk Factor Counseling
Behavioral: Risk Factor Counseling Plus Computerized Dashboard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Personalized Dashboard to Educate Veterans at Risk of Stroke

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Risk of Cardiovascular Event [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: July 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Patients randomized to this arm will be followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They will have no contact with study personnel and will not receive an intervention.
Experimental: Arm 2
Patients randomized to the intervention arm will be seen twice over six months by a research nurse to collect data on risk factors and will receive one of two interventions (counseling or counseling plus computerized dashboard).
Behavioral: Risk Factor Counseling
Patients will receive two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
Behavioral: Risk Factor Counseling Plus Computerized Dashboard
Patients will receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and will be asked to use a computerized dashboard to enter values for the risk factors and observe the effects of the risk factors on the overall cardiovascular risk.

Detailed Description:

Background:

Personalized risk communication methods have been used to educate patients who are at high risk of developing a cardiovascular event. These methods include personalized counseling, printed brochures and individualized graphs describing the status of the risk factors. Very few studies have provided an interactive tool for patients to use to compare the relative change in risk that might result from modifying their risk factors.

Objectives:

The goals of this pilot study were to: (a) develop a prototype of a personalized dynamic dashboard to educate veterans and help them make informed decisions about modifying their vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and tobacco use) to reduce the probability of a vascular event; (b) test the usability of this tool from the patient's perspective; and (c) provide preliminary data regarding the effectiveness of this tool in terms of changes in lifestyle or risk factor control compared with nurse-education.

Methods:

This was a three-arm randomized controlled study. Veterans from the panel of one experienced general internist were randomly assigned to one of three groups: (1) dashboard with nurse-education, (2) nurse-education alone, (3) usual care. To be eligible, patients must have had at least two of the following: body mass index >30 kg/m2; current tobacco use; systolic blood pressure >140 mm Hg or diastolic >90 mm Hg; LDL-cholesterol >130 mg/dL, or hemoglobin Hb1Ac >8%. We developed the dashboard in our Human Computer Interface/Information Technology laboratory. Patients in the dashboard group received two in-person counseling sessions regarding methods for controlling risk factors, and were asked to use the dashboard tool to enter values for their own risk factors and to observe the relative effects of varying their risk factor control on their overall vascular risk. The nurse-education consisted of two in-person counseling sessions regarding methods for controlling risk factors. Both intervention sessions lasted approximately 30 minutes; therefore, the majority of the time was used to interact with the tool in the dashboard group whereas the entire time was used for personalized risk factor discussion in the nurse-education group. For the usual care group, data were retrospectively collected about the primary care visits and laboratory tests which took place during the same period as the visits for intervention patients.

Status:

Completed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans receiving care from a Primary Care Clinic at the Roudebush VA Medical Center in Indianapolis with at least two of the following risk factors:
  • Body Mass Index > 30
  • Current Smoker
  • Systolic Blood Pressure > 140 mm OR Diastolic Blood Pressure >90 mm
  • Cholesterol LDL > 130 mg/dL
  • Hemoglobin Hb1Ac > 8%

Exclusion Criteria:

  • Subjects on Dialysis
  • Subjects on Supplemental Oxygen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133171

Locations
United States, Indiana
Roudebush VA Medical Center Indianapolis
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Investigators
Principal Investigator: Mahesh Merchant, PhD MSc Richard Roudebush VA Medical Center, Indianapolis
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01133171     History of Changes
Other Study ID Numbers: RRP 09-186
Study First Received: May 26, 2010
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cardiovascular Disease
Stroke

Additional relevant MeSH terms:
Cardiovascular Diseases
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014