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Completed

NCT Number: NCT00315978

The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention

The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

Background: Low utilization of effective CHD prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention.

Methods: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • presenting for routine medical care with regular medical provider
  • able to understand, speak, and read English

Exclusion criteria

  • prior history of cardiovascular disease
  • history of serious medical illness that would limit candidacy for screening
  • previous participation in intensive risk modification as part of diabetes study in our clinic
  • no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate

Treatment and study plan

Heart-to-Heart Decision Aid

Device

Primary outcomes

  1. Discussion with provider about CHD risk reduction

  2. Stated plans for CHD risk reduction

Secondary outcomes

  1. Knowledge about CHD prevention

  2. Perception of CHD risk

  3. Interest in participating in decision-making

Sponsors and collaborators

Lead sponsor

University of North Carolina

Other

Registry information

Official study title

Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

Important dates

Study start
2003
Study completion
2004
First posted
Apr 19, 2006
Registry last updated
Jul 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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