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A Personalized Dashboard to Educate Veterans at Risk of Stroke

Primary Purpose

Cardiovascular Disease, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse Alone
Dashboard Plus Nurse
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Disease focused on measuring Cardiovascular Disease, Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard Roudebush VA Medical Center, Indianapolis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Dashboard Plus Nurse

Nurse Alone

Control

Arm Description

Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling plus a computerized dashboard intervention.

Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling.

Patients randomized to this group were followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They had no contact with study personnel and did not receive any type of intervention.

Outcomes

Primary Outcome Measures

Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk
Only the intervention patients were analyzed for this outcome.

Secondary Outcome Measures

Change in Systolic Blood Pressure

Full Information

First Posted
May 26, 2010
Last Updated
October 28, 2015
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01133171
Brief Title
A Personalized Dashboard to Educate Veterans at Risk of Stroke
Official Title
A Personalized Dashboard to Educate Veterans at Risk of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Stroke
Keywords
Cardiovascular Disease, Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dashboard Plus Nurse
Arm Type
Experimental
Arm Description
Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling plus a computerized dashboard intervention.
Arm Title
Nurse Alone
Arm Type
Experimental
Arm Description
Patients randomized to this intervention arm were seen twice over six months by a research nurse to collect data on risk factors and received counseling.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomized to this group were followed retrospectively to collect data on their primary care visits and laboratory results and past medical history over the 12 month study period. They had no contact with study personnel and did not receive any type of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Nurse Alone
Intervention Description
Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
Intervention Type
Behavioral
Intervention Name(s)
Dashboard Plus Nurse
Intervention Description
Patients receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and were 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.
Primary Outcome Measure Information:
Title
Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk
Description
Only the intervention patients were analyzed for this outcome.
Time Frame
From baseline to six-months
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Time Frame
From baseline to six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahesh Merchant, PhD MSc
Organizational Affiliation
Richard Roudebush VA Medical Center, Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard Roudebush VA Medical Center, Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

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A Personalized Dashboard to Educate Veterans at Risk of Stroke

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