Essential Hypertension
Conditions
Keywords
Hypertension, African Americans, Adherence, Motivational Interviewing
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.
Interventions
BEHAVIORALMotivational 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on Morisky Medication Adherence Scale (MMAS-4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure readings | 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 | 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) | 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. |
Countries
United States
Outcome results
None listed