NCT00195182

Brief Summary

The specific aims for this study are:

  1. 1.To examine the relationship between perceived racism and medication adherence among hypertensive African-American patients.
  2. 2.To determine if psychological stress and depression mediate the relationship between perceived racism and medication adherence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
262

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

First QC Date

September 14, 2005

Last Update Submit

May 15, 2008

Conditions

Keywords

HypertensionAfrican-AmericanPerceived RacismPsychological StressMedication Adherence

Outcome Measures

Primary Outcomes (1)

  • To evaluate intervention of induced positive affect and induced self-affirmation will increase medication adherence among African-American hypertensive patients.

    every two months for one year

Study Arms (2)

1. No intervention

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.

Behavioral: Self affirmation and positive affect induction vs. control

2. Experimental

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: Self affirmation and positive affect induction vs. control

Interventions

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.

1. No intervention2. Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive African Americans

You may qualify if:

  • Patients must be self-identified as African American.
  • All patients must be aged 18 years or older.
  • 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 Guidelines on Prevention, Detection, Evaluation and Treatment of Hypertension, specifically a systolic blood pressure \>140 mm hg or a diastolic blood pressure \>90 mm hg) or if patients are taking any prescribed anti-hypertensive medication.
  • Patients must be able to provide informed consent in English.

You may not qualify if:

  • Patients who are unable to walk several blocks for any reason.
  • Patients who refused to participate.
  • Patients who are unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital-Weill Medical College

New York, New York, 10021, United States

Location

Related Publications (1)

  • Ravenell JE, Charlson ME. Stressed out: Definitions of stress among hypertensive African American men. Journal of General Internal Medicine 20(S1):128, 2005.

    BACKGROUND

MeSH Terms

Conditions

HypertensionStress, PsychologicalMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Joseph E Ravenell, MD, MS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR
  • Mary E Charlson, MD

    Weill Medical College of Cornell University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Study Completion

June 1, 2008

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations