Motivational Interviewing

This study has been terminated.
(PI left institution)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00208104
First received: September 14, 2005
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Essential Hypertension
Behavioral: Motivational Interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Motivational Interviewing in Hypertensive African Americans

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Score on Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: Up to one year from baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood pressure readings [ Time Frame: Up to one year from baseline ] [ Designated as safety issue: No ]
    Within clinic systolic and diastolic blood pressure readings will be assessed at baseline and at every three months thereafter for one year using a mercury syphgmomanometer.

  • Score on efficacy scale [ Time Frame: Up to one year from baseline ] [ Designated as safety issue: No ]
    Self-efficacy will be assessed at baseline and every three months thereafter for one year using a 44-item self-efficacy scale devised based on Bandura's Scale. Patients are asked to rate their confidence in taking their blood pressure medications under a variety of situations that may pose difficulties to them using a 3-point likert response format - 1= not at all sure, 2= somewhat sure, and 3= very sure. A summary score is computed by summing the responses, with higher scores reflecting high self-efficacy.

  • Score on the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: Up to one year from baseline ] [ Designated as safety issue: No ]
    Intrinsic motivation will be assessed at baseline and every three months thereafter for one year with aid of TSRQ. It is used to assess the degree to which one's motivation for a particular behavior is relatively autonomous or self-determined. Patients are provided with 15 reasons why they may not take their medications as prescribed and asked to indicate the degree to which each reason is true on a scale of 1 to 7 with 7 been very true.


Enrollment: 167
Study Start Date: July 2002
Study Completion Date: September 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interview Condition
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
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.
No Intervention: Non-supportive Counseling
A non-supportive counseling session will consist of regular nurse-patient interaction.

Detailed Description:

The objective of this randomized control trial is to evaluate, among 190 African-American patients with poorly controlled hypertension followed in a community-based primary care practice, whether motivational interviewing is more effective than usual care (routine counseling) in achieving adherence to prescribed blood pressure medications at 12 months.

The project aims to: 1) determine whether patients who receive motivational interview counseling have greater reduction in both systolic and diastolic blood pressure than those in the control group at 12 months. Clinic blood pressure readings will be assessed at baseline and at every three months thereafter for one year and 2) assess the effect of self-efficacy and intrinsic motivation as potential mediators of motivational interview on adherence. Self-efficacy and intrinsic motivation will be assessed at baseline and every three months thereafter for one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208104

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Gbenga Ogedegbe, MD, MS, MPH CUMC
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00208104     History of Changes
Obsolete Identifiers: NCT00201175
Other Study ID Numbers: AAAA0311, R01HL069408-03
Study First Received: September 14, 2005
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Hypertension
African Americans
Adherence
Motivational Interviewing

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014