Motivational Interviewing

Essential Hypertension Clinical Trial

Official title:

Motivational Interviewing in Hypertensive African Americans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208104
• Other study ID #: AAAA0311
• Secondary ID: R01HL069408-03
• Status: Terminated
• Phase: N/A
• First received: September 14, 2005
• Last updated: February 15, 2013
• Start date: July 2002
• Est. completion date: September 2008

Study information

• Verified date: February 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00201175

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 167
• Est. completion date: September 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Blood pressure readings	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.	Up to one year from baseline	No
Secondary	Score on efficacy scale	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.	Up to one year from baseline	No
Secondary	Score on the Treatment Self-Regulation Questionnaire (TSRQ)	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.	Up to one year from baseline	No