Clinical trial NCT00195182: Psychosocial Determinants of Medication Adherence in Hypertensive African Americans
Official title: Psychosocial Determinants of Medication Adherence in Hypertensive African Americans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
African-American
Perceived Racism
Psychological Stress
Medication Adherence
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-19
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive African Americans

Brief summary: The specific aims for this study are:

1. To examine the relationship between perceived racism and medication adherence among hypertensive African-American patients.
2. To determine if psychological stress and depression mediate the relationship between perceived racism and medication adherence.

Detailed description: Achieving and maintaining recommended blood pressure goals in hypertensive African Americans is paramount to addressing racial disparities in hypertension-related morbidity and mortality. Because antihypertensive therapy is the cornerstone of hypertension management, good medication adherence is the key to adequate blood pressure control. Successful approaches to racial disparities must address how to increase adherence to anti-hypertensive medications.

Adherence to anti-hypertensive medications is likely multifactorial, and not solely related to SES or access to medical care. Psychosocial factors such as stress and depression have been implicated as important determinants of medication adherence. However, little is known about how other psychosocial factors such as perceived racism impact anti-hypertensive medication adherence. Understanding these relationships may assist in the development of targeted strategies to achieve good medication adherence in hypertensive patients.

The objective is to understand the relationships between perceived racism and medication adherence, while examining the role of depression, psychological stress, and self-efficacy in a population of hypertensive African-American patients. 262 African American adult hypertensive patients will be recruited from an urban academic general medicine practice. Baseline data collection will include assessments of demographics and socioeconomic status, clinical history and hypertension characteristics, depressive symptoms, perceived stress, and medication adherence. Patients will be followed for 1 year, when final evaluations will take place, including assessment of hypertension, stress, depression, medication adherence and level of perceived racism (measured by a validated instrument). The primary outcome is the change in medication adherence scores from baseline to 12 months. Statistical models will be developed to determine if level of perceived racism is associated with medication adherence, and whether stress and depression play a role in this relationship.

Eligibility criteria: Inclusion Criteria:

1. Patients must be self-identified as African American.
2. All patients must be aged 18 years or older.
3. All patients must be diagnosed as having hypertension (for this project, hypertension will be defined according to the widely accepted criteria of the 6th Joint National Committee Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, specifically a systolic blood pressure \>140 mm hg or a diastolic blood pressure \>90 mm hg) or if patients are taking any prescribed anti-hypertensive medication.
4. Patients must be able to provide informed consent in English.

Exclusion Criteria:

1. Patients who are unable to walk several blocks for any reason.
2. Patients who refused to participate.
3. Patients who are unable to provide informed consent.

Primary outcomes:
measure: To evaluate intervention of induced positive affect and induced self-affirmation will increase medication adherence among African-American hypertensive patients.
timeFrame: every two months for one year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Medical College
state: New York
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Joseph E Ravenell, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: STUDY_DIRECTOR
References:
citation: Ravenell JE, Charlson ME. Stressed out: Definitions of stress among hypertensive African American men. Journal of General Internal Medicine 20(S1):128, 2005.