Motivational Interviewing

NCT ID: NCT00208104

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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.

Non-supportive Counseling

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gbenga Ogedegbe, MD, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

CUMC

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

R01HL069408-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAA0311

Identifier Type: -

Identifier Source: org_study_id

NCT00201175

Identifier Type: -

Identifier Source: nct_alias