NCT01178060

Brief Summary

The goal of this research is to improve communication to Veterans. The investigators want to improve how doctors and nurses talk to patients about the risk of heart attack and stroke. The investigators will give everyone in the study information about the risk for heart attack or stroke. The investigators will also provide information on how to reduce this risk. This information will be given in one of two ways. The investigators want to see which way of giving information works better for veterans. The investigators also want to assess the impact of personalized stroke risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors and evaluate the impact of personalized risk communication on medication adherence and blood pressure. The investigators plan to enroll approximately 100 veterans for this study. All veterans will be from the Durham VA Primary Care Clinics. The investigators will ask everyone to be in the study for 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
Last Updated

August 23, 2010

Status Verified

August 1, 2010

Enrollment Period

1.2 years

First QC Date

August 6, 2010

Last Update Submit

August 20, 2010

Conditions

Cardiovascular DiseaseStroke

Keywords

StrokeRiskCommunicationCardiovascular Disease KnowledgeImprove Risk Communication

Outcome Measures

Primary Outcomes (2)

  • Impact of personalized risk information

    Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.

    baseline

  • Impact of personalized risk information

    Assess the impact of personalized risk communication to patients at risk for stroke on patient knowledge, beliefs, and preferences for risk reduction behaviors.

    3 month

Secondary Outcomes (1)

  • Evaluate impact on medication adherence

    3-months

Study Arms (2)

Personalized Risk Information

ACTIVE COMPARATOR

Patients received personalized stroke and heart attack risk assessment information.

Other: Personalized Heart Attack and Stroke Risk

Standard Education

OTHER

Patients received general risk information on heart attack and stroke.

Other: Standard Education

Interventions

Personalized Heart Attack and Stroke RiskOTHER

Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.

Personalized Risk Information
Standard EducationOTHER

Patients received a general handout describing risk factors for heart attack and stroke.

Standard Education

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in a Durham VA Primary Care Clinic for at least one year
  • Age ≥ 55 years old
  • Diagnosis ICD 401.0, 401.1, or 401.9 on outpatient electronic encounter forms in the prior year
  • Received a prescription for hypertensive medication (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, alpha1 blockers, and/or central alpha2 agonists) in the previous year
  • Inadequate BP control based on an average of prior 12-month clinic BP measurements
  • Have a baseline EKG within the last 5 years to evaluate the presence of left ventricular hypertrophy.

You may not qualify if:

  • Hospitalized at the DVAMC for a myocardial infarction (MI), coronary artery revascularization, or diagnosis of metastatic cancer in the past 6 months
  • Prior history of stroke
  • Active diagnosis of psychosis or dementia documented in medical record
  • Participating in another chronic disease self-management study
  • Resident of a nursing home
  • Does not have access to a telephone
  • Refusal to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Powers BJ, Danus S, Grubber JM, Olsen MK, Oddone EZ, Bosworth HB. The effectiveness of personalized coronary heart disease and stroke risk communication. Am Heart J. 2011 Apr;161(4):673-80. doi: 10.1016/j.ahj.2010.12.021.

    PMID: 21473965DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesStrokeCommunication

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesBehavior

Study Officials

  • Hayden Bosworth, PhD

    Durham VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

August 6, 2010

First Posted

August 9, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 23, 2010

Record last verified: 2010-08

Locations

US(1)