Psychosocial Determinants of Medication Adherence in Hypertensive African Americans

Hypertension Clinical Trial

Official title:

Psychosocial Determinants of Medication Adherence in Hypertensive African Americans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00195182
• Other study ID #: 0302006001
• Status: Active, not recruiting
• Phase: N/A
• First received: September 14, 2005
• Last updated: May 15, 2008
• Start date: September 2003
• Est. completion date: June 2008

Study information

• Verified date: May 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 262
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Self affirmation and positive affect induction vs. control
During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their medication adherence. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital-Weill Medical College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ravenell JE, Charlson ME. Stressed out: Definitions of stress among hypertensive African American men. Journal of General Internal Medicine 20(S1):128, 2005.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate intervention of induced positive affect and induced self-affirmation will increase medication adherence among African-American hypertensive patients.		every two months for one year	No