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Sponsors and Collaborators: |
Weill Medical College of Cornell University National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00248872 |
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.
Condition | Intervention |
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Hypertension |
Behavioral: Positive affect and self-affirmation induction |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients |
Estimated Enrollment: | 262 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | July 2008 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: 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.
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Behavioral: 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.
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2: 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.
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Behavioral: 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.
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
The New York Presbyterian Hospital-Weill Medical Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Carla Boutin-Foster, MD,MS | Weill Medical College of Cornell University |
Principal Investigator: | Gbenga Ogedegbe, MD, MS | Columbia University College of Physicians and Surgeons |
Study Director: | Mary E Charlson, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Cornell Medical College ( Mary E. Charlson, MD ) |
Study ID Numbers: | N01-HC-25196 (0203-704) |
Study First Received: | November 3, 2005 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00248872 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
African-American Hypertension Medication adherence Risk reduction |
Vascular Diseases Hypertension |
Cardiovascular Diseases |