Clinical trial NCT00248872: A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Official title: A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: African-American
Hypertension
Medication adherence
Risk reduction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Within patient change in medication adherence as measured by the MEMS cap.
timeFrame: Every two months for one year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Carla Boutin-Foster, MD,MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Gbenga Ogedegbe, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: STUDY_DIRECTOR
References:
citation: Boutin-Foster C, Ravenell JE, Greenfield VW, Medmim B, Ogedegbe G. Applying qualitative methods in developing a culturally tailored workbook for black patients with hypertension. Patient Educ Couns. 2009 Oct;77(1):144-7. doi: 10.1016/j.pec.2009.03.008. Epub 2009 Apr 16.
citation: Boutin-Foster C, Ogedegbe G, Ravenell JE, Robbins L, Charlson ME. Ascribing meaning to hypertension: a qualitative study among African Americans with uncontrolled hypertension. Ethn Dis. 2007 Winter;17(1):29-34.
citation: Ogedegbe GO, Boutin-Foster C, Wells MT, Allegrante JP, Isen AM, Jobe JB, Charlson ME. A randomized controlled trial of positive-affect intervention and medication adherence in hypertensive African Americans. Arch Intern Med. 2012 Feb 27;172(4):322-6. doi: 10.1001/archinternmed.2011.1307. Epub 2012 Jan 23.