A Personalized Dashboard to Educate Veterans at Risk of Stroke

NCT01133171 | Completed Results

• 1 other identifier: RRP 09-186
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Stroke

Keywords

Cardiovascular Disease; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of Participants Who Initiate Conversation With Primary Care Provider About Vascular Risk

  Only the intervention patients were analyzed for this outcome.

  From baseline to six-months

Secondary Outcomes (1)

• Change in Systolic Blood Pressure

  From baseline to six months

Study Arms (3)

Dashboard Plus Nurse

EXPERIMENTAL

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.

Behavioral: Nurse Alone; Behavioral: Dashboard Plus Nurse

Nurse Alone

EXPERIMENTAL

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.

Behavioral: Nurse Alone

Control

NO INTERVENTION

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.

Interventions

Nurse Alone BEHAVIORAL

Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.

Dashboard Plus Nurse; Nurse Alone

Dashboard Plus Nurse BEHAVIORAL

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.

Dashboard Plus Nurse

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Subjects on Dialysis
• Subjects on Supplemental Oxygen

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke

Interventions

Nurses

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dawn M. Bravata, MD
• Organization: Department of Veterans Affairs

dawn.bravata2@va.gov

317-988-2676

Study Officials

• Mahesh Merchant, PhD MSc

  Richard Roudebush VA Medical Center, Indianapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 30, 2015
• Results First Posted: October 30, 2015

Record last verified: 2015-10

Locations

US (1)