NCT00208104

Brief Summary

The purpose of this project is to study ways to make it more likely that patients will take their blood pressure medicine as recommended by their doctors.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Last Update Submit

February 15, 2013

Conditions

Essential Hypertension

Keywords

HypertensionAfrican AmericansAdherenceMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Score on Morisky Medication Adherence Scale (MMAS-4)

    Adherence to antihypertensive medications will be assessed at baseline and every three months thereafter for one year using a validated 4-item scale developed by Morisky that specifically addresses medication-taking. The scale asks patients to respond "yes" or "no" to a set of 4 questions. A positive response to any question indicates a problem with adherence. Each positive answer is assigned a score of 1. The total possible score is 4 with higher score indicating poorer adherence.

    Up to one year from baseline

Secondary Outcomes (3)

  • Blood pressure readings

    Up to one year from baseline

  • Score on efficacy scale

    Up to one year from baseline

  • Score on the Treatment Self-Regulation Questionnaire (TSRQ)

    Up to one year from baseline

Study Arms (2)

Motivational Interview Condition

EXPERIMENTAL

Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial.

Behavioral: Motivational Interviewing

Non-supportive Counseling

NO INTERVENTION

A non-supportive counseling session will consist of regular nurse-patient interaction.

Interventions

Motivational InterviewingBEHAVIORAL

Trained nurses will interview the group using motivational interview counseling techniques. All sessions will be conducted with the aid of an adapted version of a standardized structured adherence counseling script. This script was specifically developed for use in medication adherence studies of HIV positive patients and has been provided for this trial.

Motivational Interview Condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The target population consisted of hypertensive African American patients who fulfilled the following eligibility criteria:
  • Self-identification as African American
  • Age 18 years or older
  • Diagnosis of hypertension utilizing ICD-9 codes 401-401.9 (the code for essential hypertension)
  • Taking at least one antihypertensive medication
  • Uncontrolled hypertension of a clinic blood pressure reading \>140/90 mm Hg or 130/80 mm Hg (for those with kidney disease or diabetes) on two successive clinic visits prior to screening (defined per JNC VI criteria)
  • Fluent in English language

You may not qualify if:

  • Participants were excluded if they:
  • Had a diagnosis of cognitive impairment or serious medical condition as determined by their primary physician
  • Were unable to give informed consent
  • Refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gbenga Ogedegbe, MD, MS, MPH

    CUMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

July 1, 2002

Primary Completion

May 1, 2006

Study Completion

September 1, 2008

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)