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A Pilot Study of Changing Medication Adherence In Hypertensive African-American Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248937
First Posted: November 4, 2005
Last Update Posted: April 3, 2008
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
  Purpose
We will conduct an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation.

Condition Intervention
Hypertension Behavioral: Positive affect and self-affect induction

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Pilot Study of Changing Medication Adherence In Hypertensive African-American Patients

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Within patient change on the Positive and Negative Affect Scale

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: June 2004
Detailed Description:

We are interested in achieving an empirical test of the two intervention approaches under study. Specifically, we seek to determine the potential differential impact of positive affect induction and self affirmation following the qualitative phase.

  1. Positive affect induction: We will tests two types of positive affect induction. 1) sending patients a small gift, and 2) reminding patients of positive thoughts about themselves.

    Gift: Prior to a telephone call, patients in the positive affect condition will receive a small gift.

    Positive thoughts about themselves: Patients will be asked to describe a time when someone was helpful to them, and they felt good about it , and were nice to them in return.

  2. Self affirmation: consists of a series of items reminding people of their core values.
  3. Control: Control patients will have neither self affirmation nor gifts.

Follow-up: At two weeks after enrollment all patients will be called to ascertain impact of the pilot intervention.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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): NCT00248937


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
National Heart, Lung, and Blood Institute (NHLBI)
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

Responsible Party: Mary E. Charlson, MD, Weill Medical College
ClinicalTrials.gov Identifier: NCT00248937     History of Changes
Other Study ID Numbers: N01-HC-25196 (0203-703)
First Submitted: November 3, 2005
First Posted: November 4, 2005
Last Update Posted: April 3, 2008
Last Verified: April 2008

Keywords provided by Weill Medical College of Cornell University:
African-American
Hypertension
Medication adherence
Risk reduction

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases