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CompletedNCT00248872Updated Feb 23, 2017

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

An interventional study of Intervention Group in Hypertension, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2004, registered Nov 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
18 Years to 110 Years
Sex
All
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Study 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.

Read the 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).

  1. 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.
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Conditions studied

  • Hypertension

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Keywords

  • African-American
  • Hypertension
  • Medication adherence
  • Risk reduction
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 278 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
278 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralIntervention 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.

    Also known as: Positive affect and self-affirmation induction

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What researchers measure

Primary outcomes

  1. Within patient change in medication adherence as measured by the MEMS cap.

    Time frame: Every two months for one year

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Study locations

1 site
  • The New York Presbyterian Hospital-Weill Medical Center
    New York, New York 10021, United States
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References and documents

Publications

  • 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. PubMed 19375264 ↗
  • 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. PubMed 17274206 ↗
  • 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. PubMed 22269592 ↗

Individual participant data

Plan to share: No — No Plan to Share IPD

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00248872
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Mary E. Charlson, MD (Principal Investigator, Weill Medical College of Cornell University) — Principal investigator
First posted
Nov 4, 2005
Start date
Oct 2004
Primary completion
Sep 2006
Completion
Jul 2008
Last update
Feb 23, 2017

Study contacts

Carla Boutin-Foster, MD,MS
principal investigator · Weill Medical College of Cornell University
Gbenga Ogedegbe, MD, MS
principal investigator · Columbia University
Mary E Charlson, MD
study director · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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