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Motivational Interviewing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00208104
Recruitment Status : Terminated (PI left institution)
First Posted : September 21, 2005
Last Update Posted : February 18, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Columbia University

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date February 18, 2013
Study Start Date  ICMJE July 2002
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
Score on Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: Up to one year from baseline ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Adherence to antihypertensive medications assessed at baseline and every three months thereafter for one year.
Change History Complete list of historical versions of study NCT00208104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2012)
  • Blood pressure readings [ Time Frame: Up to one year from baseline ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Within clinic systolic and diastolic blood pressure readings assessed at baseline and at every three months thereafter for one year
  • Self-efficacy assessed at baseline and every three months thereafter for one year.
  • Intrinsic motivation assessed at baseline and every three months thereafter for one year
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Motivational Interviewing
Official Title  ICMJE Motivational Interviewing in Hypertensive African Americans
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Condition  ICMJE Essential Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Motivational Interviewing
  • No Intervention: Non-supportive Counseling
    A non-supportive counseling session will consist of regular nurse-patient interaction.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 22, 2012)
167
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
190
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00208104
Other Study ID Numbers  ICMJE AAAA0311
R01HL069408-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Gbenga Ogedegbe, MD, MS, MPH CUMC
PRS Account Columbia University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP