Clinical trial NCT00208104: Motivational Interviewing
Official title: Motivational Interviewing in Hypertensive African Americans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Essential Hypertension
Keywords: Hypertension
African Americans
Adherence
Motivational Interviewing
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-21
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Score on Morisky Medication Adherence Scale (MMAS-4)
timeFrame: Up to one year from baseline
Secondary outcomes:
measure: Blood pressure readings
timeFrame: Up to one year from baseline
measure: Score on efficacy scale
timeFrame: Up to one year from baseline
measure: Score on the Treatment Self-Regulation Questionnaire (TSRQ)
timeFrame: Up to one year from baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: CUMC
name: Gbenga Ogedegbe, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References: