Overview

This trial is active, not recruiting.

Condition hypertension
Treatment positive affect and self-affirmation induction
Sponsor Weill Medical College of Cornell University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date October 2004
End date September 2006
Trial size 262 participants
Trial identifier NCT00248872, N01-HC-25196 (0203-704)

Summary

The long-term objective is to determine whether better adherence to prescribed medications can be achieved through positive affect induction and self-affirmation leading to reduction in hypertension-related outcomes such as end-stage renal disease, stroke, and cardiovascular mortality among African American patients with poorly controlled hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(No Intervention)
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.
positive affect and self-affirmation induction
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.
(Experimental)
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.
positive affect and self-affirmation induction
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
Within patient change in medication adherence as measured by the MEMS cap.
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-Americans. 2. All patients must be aged 18 years and 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 (JNC VI) Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, which is a systolic blood pressure > 140 mm hg or a diastolic blood pressure > 90 mm hg or if participants are taking any prescribed antihypertensive 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 A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Principal investigator Carla Boutin-Foster, MD,MS
Description The objective of this randomized trial is to evaluate, among African American patients with poorly controlled hypertension, whether a novel intervention of positive affect induction and self-affirmation is more effective than usual care in increasing adherence to prescribed antihypertensive medications. The main outcome will be the change in medication adherence rate from enrollment to 12 months, which is defined as percentage (%) of prescribed doses taken by the patient during the interval of observation as measured by electronic medication event monitoring system (MEMS). 2. Secondary objectives 1. To determine, among African American patients with poorly controlled hypertension, the extent to which positive affect induction and self-affirmation influence patients' self-efficacy. 2. To determine, among African American patients with poorly controlled hypertension, the extent to which positive affect induction and self-affirmation influence medication adherence in those with significant depressive symptomatology (CES-D score > 16). 3. To determine, among African-American patients with poorly controlled hypertension, the extent to which positive affect induction and self-affirmation influence blood pressure control. 4. To explore the health beliefs of hypertensive African-American patients, regarding the meaning, causes and treatment of hypertension. In addition, the factors that facilitate and prevent adherence to prescribed antihypertensive medications will also be explored using a qualitative approach.
Trial information was received from ClinicalTrials.gov and was last updated in April 2008.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.