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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00248937
First received: November 3, 2005
Last updated: April 1, 2008
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Study of Changing Medication Adherence In Hypertensive African-American Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 College of Physicians and Surgeons
Study Director: Mary E Charlson, MD Weill Medical College of Cornell University
  More Information

No publications provided

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)
Study First Received: November 3, 2005
Last Updated: April 1, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013