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A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248872
First Posted: November 4, 2005
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary E. Charlson, MD, Weill Medical College of Cornell University
  Purpose
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
Hypertension Behavioral: Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients

Resource links provided by NLM:


Further study details as provided by Mary E. Charlson, MD, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Within patient change in medication adherence as measured by the MEMS cap. [ Time Frame: Every two months for one year ]

Enrollment: 278
Actual Study Start Date: October 2004
Study Completion Date: July 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
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.
Experimental: Intervention Group
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.
Behavioral: Intervention Group
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.
Other Name: Positive affect and self-affirmation induction

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

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248872


Locations
United States, New York
The New York Presbyterian Hospital-Weill Medical Center
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Carla Boutin-Foster, MD,MS Weill Medical College of Cornell University
Principal Investigator: Gbenga Ogedegbe, MD, MS Columbia University
Study Director: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Mary E. Charlson, MD, Principal Investigator, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00248872     History of Changes
Other Study ID Numbers: N01-HC-25196 (0203-704)
First Submitted: November 3, 2005
First Posted: November 4, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan to Share IPD

Keywords provided by Mary E. Charlson, MD, Weill Medical College of Cornell University:
African-American
Hypertension
Medication adherence
Risk reduction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases