A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
This trial is active, not recruiting.
|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)|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Within patient change in medication adherence as measured by the MEMS cap.
time frame: Every two months for one year
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.
|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.|
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