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Completed

NCT Number: NCT01037920

An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

The objective of the project is a test-of-concept of an intervention to reduce the effects of the perception of discrimination on the care of patients with chronic illness. Perception of discrimination manifests itself as stereotype threat. We hypothesize that stereotype threat impairs communication between minority patients and their physicians because of increased stress and diminished trust, resulting in interactions that are less successful at enhancing patient self-efficacy, in turn resulting in lower rates of adherence with anti-hypertensive medication.

The intervention is a self-affirmation exercise performed prior to a patient-physician visit. A similar intervention has been shown to reduce the racial gap in academic performance in middle school classrooms.

We will explore the mechanistic effects of the intervention by analysis of audiotapes of patient-provider visits following the intervention. We will measure the effect of the intervention on minority hypertensive patients' adherence with antihypertensive medication and blood pressure.

We will enroll 200 African American and Latino patients with hypertension and randomize 100 patients to perform the exercise and 100 patients to perform a null control exercise before the visit. We will assess change in patient's adherence with antihypertensive medications and in blood pressure over the six months following the index visit. In order to better understand the effects of the intervention we will measure subject's mood following the exercise, and self-reported stress levels, trust in the physician, and medication self-efficacy following the visit. We will also assess the quality of the patient-provider interaction from detailed analysis of audiotapes and from patient questionnaires. Following a subsequent patient-physician visit, we will conduct telephone interviews with patients to assess for persistence of any effects of the intervention.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of hypertension
  • age > 21 years
  • use of Denver Health as their usual source of care and pharmacy services
  • self-described race/ethnicity of African American or Latino
  • ability to provide informed consent

Exclusion criteria

  • pregnancy-related hypertension
  • end-stage renal disease
  • unable to speak or write English at at least a 6th grade level.

Treatment and study plan

Self-affirmation exercise

Behavioral

The intervention exercise asks subjects to reflect on a list of 11 personal values and to circle 2 or 3 items that are most important to them. Subjects are asked then to write a few sentences to describe why they are important.

Control

Behavioral

The control exercise is the same as the intervention exercise except that subjects reflect and write about values important to someone else.

Primary outcomes

  1. medication adherence

    Time frame: 6 months

Secondary outcomes

  1. Blood pressure

    Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2009
Registry last updated
Jul 13, 2012

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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