Overview

This trial is active, not recruiting.

Condition hypertension
Treatment self affirmation and positive affect induction vs. control
Sponsor Weill Medical College of Cornell University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2003
End date June 2008
Trial size 262 participants
Trial identifier NCT00195182, 0302006001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
This group received follow-up every 2-months for one year. Follow-up included questions about their blood pressure and how well they had been able to adhere to their medication goal.
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.
This group received follow-up every 2-months for one year. Follow-up included questions about their blood pressure and how well they had been able to engage adhere to their medication goal. 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 physical activity level.
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.

Primary Outcomes

Measure
To evaluate intervention of induced positive affect and induced self-affirmation will increase medication adherence among African-American hypertensive patients.
time frame: every two months for one year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Psychosocial Determinants of Medication Adherence in Hypertensive African Americans
Principal investigator Joseph E Ravenell, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.