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

NCT00248872 | Completed DMC

• 2 other identifiers: N01-HC-25196 (0203-704)N01HC25196
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

African-American; Hypertension; Medication adherence; Risk reduction

Outcome Measures

Primary Outcomes (1)

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

  Every two months for one year

Study Arms (2)

control group

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.

Intervention Group

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: Intervention Group

Interventions

Intervention Group BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be self-identified as African-Americans.
• All patients must be aged 18 years and 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 (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.
• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

The New York Presbyterian Hospital-Weill Medical Center

New York, New York, 10021, United States

Location

Related Publications (3)

• 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.

  PMID: 19375264 BACKGROUND

• 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.

  PMID: 17274206 BACKGROUND

• 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.

  PMID: 22269592 RESULT

MeSH Terms

Conditions

Hypertension; Medication Adherence; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carla Boutin-Foster, MD,MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Gbenga Ogedegbe, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Mary E Charlson, MD

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: July 1, 2008
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)