Contemporary Clinical Trials 28 (2007) 169 181

www.elsevier.com/locate/conclintrial

An RCT of the effect of motivational interviewing on medication

adherence in hypertensive African Americans: Rationale and design
Gbenga Ogedegbe , Antoinette Schoenthaler, Tabia Richardson, Lisa Lewis,
Rhonda Belue, Eugenia Espinosa, Jacqueline Spencer,
John P. Allegrante, Mary E. Charlson
Columbia University Medical Center, United States
Received 6 December 2005; accepted 12 April 2006

Abstract

Background: Hypertension disproportionately affects African Americans compared to whites, and it is the single most common
explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can
help reduce risk of negative hypertension-related outcomes. Motivational interviewing is a promising patient-centered approach for
improving adherence in patients with chronic diseases. In this paper we describe the rationale and design of an ongoing randomized
controlled trial testing the effectiveness of motivational interviewing versus usual care in improving medication adherence among
190 African American uncontrolled hypertensive patients, who receive care in a primary care setting.
Methods: The usual care group receives standard medical care, while those in the intervention group receive standard care plus four
sessions of motivational interviewing at 3-month intervals for a period of 1 year. This technique consists of brief, patient-driven
counseling sessions to facilitate initiation and maintenance of behavior change. The primary outcome is adherence to prescribed
antihypertensive medication, assessed with the electronic medication events monitoring system (MEMS) and the Morisky self-
report adherence questionnaire. Secondary outcomes are within-patient changes in blood pressure, self-efficacy, and intrinsic
motivation between baseline and 12 months. We report the baseline sociodemographic and clinical characteristics of the
participants.
Conclusions: Despite the potential utility of motivational interviewing, little is known about its effectiveness in improving
medication adherence among hypertensive patients, especially African Americans. In addition to the baseline data this study has
generated, this trial should provide data with which we can assess the effectiveness of this approach as a behavioral intervention.
2006 Elsevier Inc. All rights reserved.

Keywords: Medication adherence; Hypertension; Motivational interviewing; African Americans; Randomized trial

1. Introduction

The disproportionately high prevalence of cardiovascular disease, including hypertension (HTN) in African Americans,
is well documented [1,2]. The age-adjusted prevalence of HTN in African Americans is 33.5%, compared to 28.9% for

Corresponding author.
E-mail address: goo1@columbia.edu (G. Ogedegbe).

1551-7144/$ - see front matter 2006 Elsevier Inc. All rights reserved.
doi:10.1016/j.cct.2006.04.002
170 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

whites [3], making the prevalence in African Americans the highest in the US. African Americans have a 1.8 times greater
rate of fatal stroke, a 1.5 times greater rate of heart disease death, and a 4.2 times greater rate of HTN-related end-stage
kidney disease than do whites [48], most of which are attributable to uncontrolled HTN. Thus, it is not surprising that the
single most common explanation for the disparity in mortality between African Americans and whites is HTN [9]. A
possible reason for the worse outcomes seen in hypertensive African Americans compared to whites may be the poor rate of
medication adherence in hypertensive African Americans with almost half (48%) of patients enrolled in the African
American Study of Kidney Disease and Hypertension (AASK) categorized as nonadherent by pill count [10]. In the study
by Charles et al. African Americans are almost twice as likely as whites to be nonadherent with cardiac medications
including antihypertensives [11]. Similarly, in a study of 239 elderly hypertensive patients seen primary care practice,
Krousel-Wood et al. showed that the odds ratio of perfect medication compliance was 2.53 (1.374.66) for whites versus
nonwhites [12]. Bosworth et al. recently confirmed similar findings in a cohort of 569 Veteran Affairs patients [13].
Addressing the issue of poor medication adherence in hypertensive African Americans is an important initial step towards
achieving the Healthy People 2010 objective of eliminating the health disparities associated with hypertension-related
outcomes. Evidence to date indicate that successful interventions designed to improve medication adherence in patients
with chronic diseases are those that involve patient activation, address patients' beliefs and concerns about their me-
dications; are emotively supportive and enhance patients' confidence in their abilities to overcome barriers to adherence
[1419].
Motivational interviewing encompasses several of the strategies outlined above. It is defined as a directive, patient-
centered approach to counseling designed to motivate people for change by helping them to recognize and resolve the
discrepancy between their present behavior, and their future personal goals and values. Motivational interviewing is
composed of principles and techniques drawn from various theoretical paradigms, the most important of which, are its
patient-centeredness [20,21]; its ability to enhance patient's self-efficacy; its focus on patients' readiness to change
behavior [22]; as well as helps patients clarify goals, explore their perceived barriers to treatment, and make commitment to
change. This counseling approach suggests that for change in behavior to occur, the patient must feel convinced that
change will improve his/her well being, and confident that he/she can make this change. In other words, s/he must be self-
efficacious about his or her ability to make the change. The broadest application of motivational interviewing is in the area
of addictive behaviors [2326]. It is only in the recent past that motivational interviewing is beginning to be utilized in
improving treatment adherence and outcomes in other areas of health behavior change like obesity [27], diabetes, HIV risk
factor modification [2832], dietary adherence [33,34], fruit and vegetable intake [35], mammography screening [3638],
eating disorders [3942]. Despite the utility of this counseling approach, little is known about effectiveness in improving
medication adherence among hypertensive patients, especially African Americans. Moreover, the mechanism through
which motivational interviewing affects behavior change is not well studied.
In this paper, we describe the rationale and design of a randomized controlled clinical trial evaluating the
effectiveness of motivational interviewing versus usual care in improving medication adherence among hypertensive
African American patients who receive care in a primary care setting. The secondary objective was to assess the
differential effects of the intervention versus usual care on blood pressure (BP), self-efficacy, and intrinsic motivation.
We hypothesized that patients randomized to motivational interviewing compared to those in usual care will have a: (i)
greater rate of medication adherence at 12 months; (ii) greater within-patient change in both systolic and diastolic blood
pressure from baseline to 12 months; and (iii) greater positive change in both self-efficacy and intrinsic motivation from
baseline to 12 months.

2. Methods

2.1. Study design

The study is a randomized controlled clinical trial in which 190 patients were randomly assigned to one of two groups:
motivational interviewing or a usual care control group. Individuals in the control group received standard medical care,
while those in the intervention group received standard care plus four sessions of motivational interviewing at 3-month
intervals. The primary outcome is adherence to prescribed antihypertensive medication. This is assessed with both
objective electronic Medication Event Monitoring System (MEMS) and the subjective medication adherence scale
developed by Morisky et al. [43]. The secondary outcomes are within-patient changes in both systolic blood pressure
(SBP) and diastolic blood pressure (DBP), and within-patient changes in self-efficacy and intrinsic motivation from
 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181 171

baseline to 12 months. Patients in both groups were assessed at baseline and every 3 months for these outcomes. Follow-up
assessments were carried out every 3 months on all patients for a period of 1 year. During follow-up assessments patients'
medication adherence patterns were downloaded from their MEMS, their self-report medication adherence was assessed,
their clinic blood pressure (BP) readings were retrieved from their charts, and their self-efficacy and intrinsic motivation
were also assessed. Final assessment was conducted at 1 year.

2.2. Study setting

Patients were recruited from two primary care practices affiliated with New York Presbyterian Hospital's Am-
bulatory Care Network (ACN). One was a community-based practice, while the other was a hospital-based practice.
The ACN is a consortium of over 20 community health centers that serve low-income, predominantly minority
populations in underserved areas of New York City.

2.3. Patient eligibility

2.3.1. Inclusion criteria

Patients are enrolled in the trial if they fulfill the following eligibility criteria: (i) self-identification as African
American, (ii) age 18 years or older, (iii) diagnosis of HTN with ICD-9 codes 401401.9, (iv) taking at least one
antihypertensive medication, (v) uncontrolled HTN on two successive clinic visits prior to screening (clinic BP 140/
90 mm Hg or 130/80 mm Hg for those with kidney disease or diabetes) [44], and (vi) fluent in English language.

2.3.2. Exclusion criteria

Participants were excluded if they (i) had a diagnosis of cognitive impairment or serious medical condition as
determined by their primary care physician, (ii) were unable to provide informed consent, or (iii) refused to
participate.

2.4. Approvals and data and safety monitoring

The study was approved through the Weill Medical College and Columbia University Institutional Review Boards.
Participants provided written informed consent prior to enrollment, and recruitment procedures were in accordance
with the Health Information Portability and Accountability Act (HIPAA) regulations.

2.5. Procedures

2.5.1. Patient screening, recruitment, and enrollment

As stated above, all patients were recruited from two ACN primary care practices. Ethnic minorities are often
underrepresented in clinical trials, and their recruitment is often a challenge for researchers. We adopted the following
steps in patient recruitment: Potentially eligible patients were identified via chart reviews (in the case of the hospital-
based practice) and via review of electronic medical records (in the case of the community-based practice). Physicians
of eligible patients were notified of their patients' potential eligibility and asked permission to enroll their patients in
the study. After consent was obtained from the physicians, the clinic appointment dates of potentially eligible patients
were noted and patients were approached on their next clinic appointments. Furthermore, we asked the patients for the
numbers of friends, and relatives who may know their whereabouts in case they are lost to follow-up. We also engaged
the front desk staff in recruitment of patients given that they are much more familiar with the patients and have gained
their trust over the years. Those who agreed to participate were asked to provide written informed and then scheduled
for a baseline assessment with the research assistant (RA) at which time they were randomized into the study. All
patients were offered a modest compensation of $100 for their time and effort. Recruitment began July 1, 2002 and
ended May 18, 2005. Follow-up of patients is ongoing and is projected to continue until May 18, 2006.

2.5.2. Baseline assessment

Baseline assessments were performed no later than 1 week after enrollment into the study. During the evaluation,
patients were give one MEMS bottle for their antihypertensive medication. After the interview, the RA explained the
172 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

general purpose of the bottle and instructed the patient on how to use it. The patient was told to use the MEMS
everyday as they would their regular pharmacy bottles. If patients were taking more than one antihypertensive
medication, they are instructed to keep their primary medication (as determined previously by their physicians) in the
MEMS bottle. The MEMS bottle also has a label with the patient's name, medication and dosage. After the RA
received verbal consent that the patient understood the importance of using the MEMS they were given a tip sheet. The
sheet reminded patients to put their refills in the MEMS bottle, to use it daily, and bring it to their medical appointments.
One week after the baseline appointment patients were called to confirm that they put the correct medication in the bottle
and asked if they had any questions. Information collected at baseline includes patients' demographics; clinical history
(duration of diagnosis of hypertension, treatment for hypertension, number of prescribed antihypertensive medications,
their doses); measures of self-report medication adherence, self-efficacy, intrinsic motivation, social support, and
depression. In addition, medical records were reviewed for baseline clinic BP readings and medical comorbidity. All BP
readings were taken by nurses or medical assistants in both practices. Following completion of the baseline assessment,
patients were randomly assigned to either the usual care or motivational interviewing group, and an appointment was
scheduled for them to return to the clinic for their first 3-month visit.

2.5.3. Randomization and blinding

Separate randomization schedules were developed from a computerized random-number generator, balanced at set
intervals, using permutated blocks in order to assure equal numbers in each arm. Randomization assignment was
carried out by the study statistician using sealed envelopes. Upon randomization, each patient was entered into the
study and included in the intention-to-treat analysis. A total of 95 patients were randomly assigned to each study group.
As is typical for most behavioral interventions, neither the patient nor the RA delivering the motivational interviewing
could be blinded to the intervention assignment. However, the primary-care physician did not know the randomization
group to which his or her patient belonged.

2.5.4. Treatment groups

For both the motivational interviewing and the usual care groups, the study was implemented in two phases: an
initiation phase and a follow-up phase. The initiation phase occurred 3 months after the baseline visit and the follow-up
phase comprised subsequent three-monthly visits thereafter at 6, 9, and 12 months.

2.5.4.1. Initiation phase. During this phase, which lasted up to 45 min, patients were interviewed in person by trained
research assistants. They completed all study related questionnaires, data from their MEMS caps (for the previous
3 months) were downloaded, and their medical records were reviewed for clinic BP readings. At the end of this session
patients are reminded that subsequent sessions will take place every 3 months for a period of 12 months and that they
will be reminded of their appointments 2 weeks prior.
2.5.4.1.1. Motivational interviewing group. Patients randomized to this group underwent behavioral counseling
about medication adherence using motivational interviewing techniques. All sessions were conducted with the aid of an
adapted version of a standardized structured adherence counseling script, which was specifically developed for use in
medication adherence studies of HIV positive patients by Dilorio et al. [45]. After establishing rapport with the patient,
the RA goes through the following sequential steps: (i) assess the patient's motivation and confidence, (ii) elicit
barriers, concerns, and positive self-motivational statements about their adherence behavior, (iii) summarize the pros
and cons of proposed behavioral change (i.e., adhering to recommended medication), (iv) provide menu of options,
and finally, (v) clarify behavioral contract and give a global summary of the counseling session. The duration of the
baseline motivational interviewing session was approximately 40 min. The details of what happens at each of the
motivational interviewing session can be found in Appendix A.
Treatment fidelity and integrity: Treatment fidelity issues were addressed by using the expanded treatment imple-
mentation model developed by Bellg et al. [46]. All motivational interviewing sessions are performed by trained RAs.
Experienced Motivational Interview Trainers conducted the training sessions yearly for the RAs which included
lectures and supervised role-plays. The RAs attended two training sessions that lasted 8 hours each in the first year of
the study and a 1-day booster training session yearly thereafter in order to minimize decay. Additionally, all sessions
were audio taped and fidelity of the RA to the techniques of motivational interviewing was assessed on an on-going
basis by a trained rater, who provides feedback to the RAs on the necessary counseling scripts based on the audio tape
recordings.
 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181 173

Table 1
Measures obtained in the study
Measure Baseline 3 months 6 months 9 months 12 months
Medication Event Monitoring (MEMS)
Clinic blood pressure readings
Chart review a
Demographics
Charlson Comorbidity Index
Morisky Scale: Self-Reported Adherence
Medication Adherence Self-efficacy Scale
Treatment Self-Regulation Questionnaire
CES-D (depression)
Duke Social Support and Stress Scale
a
Chart reviews are conducted to collect data on the treatment changes especially as it relates to medication changes and comorbidity changes.

2.5.4.1.2. Usual care control group. Upon entry into the trial, patients randomized to the usual care group did not
receive any motivational interviewing counseling, but completed all assessment interviews at the same time points as
the intervention group.

2.5.4.2. Follow-up phase. The follow-up phase occurred 3 months after the initiation phase and comprised subse-
quent three-monthly visits. There were a total of three follow-up sessions for each patient, all occurring at 6, 9, and
12 months. During this phase, patients in both study groups were again interviewed in person.
Motivational interviewing group: Those in the motivational interviewing group received three additional counseling
sessions identical to the one they received during the initial phase. However, the duration of the motivational inter-
viewing was shorter with each lasting about 2530 min. The content of these follow-up sessions were based on the
summary and contract from the previous sessions.
Usual care control group: Patients in the usual care control group did not receive any motivational interviewing
counseling but completed all assessment interviews at the same time points as the intervention group.
As with the initial phase, patients in both groups completed all study related questionnaires, adherence data from
their MEMS caps for the previous 3 months were downloaded at each follow-up visit, and their medical records were
reviewed for clinic BP readings.

2.5.4.3. Final evaluation. The final evaluation was carried out at 12 months after the baseline visit. At this time, those in
the intervention received their last motivational interviewing counseling session following the same format and structure as
with their 9-month follow-up phase; while those in the usual care did not receive any counseling. Patients in both groups
completed their final study related questionnaires, adherence data from their MEMS caps for the previous 3 months were
downloaded, and patients' medical records were reviewed for clinic BP readings. Additionally, we conduct an exit
interview with the patients asking them their experiences with motivational interviewing sessions and the barriers they
experience with participation in this trial.

2.6. Measures

Study measures included the Morisky self-report medication adherence questionnaire, the CES-D measure of
depression, the Duke Social Support and Stress Scale (DUSOCS), the Charlson comorbidity index, the medication
adherence self-efficacy scale (MASES), and the Treatment Self-Regulation questionnaire (TSRQ) measure of intrinsic
motivation. Table 1 shows the measures taken at each assessment study visit.

2.6.1. Primary outcomes

The primary outcome for this study is adherence to prescribed antihypertensive medications, which was
assessed though an objective MEMS and the use of a subjective Morisky self-report medication adherence
questionnaire.
174 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

2.6.1.1. Medication Event Monitoring System (MEMS). Adherence is defined in two ways using this measure: (i)
percent of prescribed doses removed by the patient during the interval of observation by formula:

Number of doses removed=Number of doses prescribed*100:

This is basically a standard pill count. The disadvantage of this formula is that it does not account for information
about the timing of the dose removal; and (ii) percent of days during which less than the prescribed number, the
prescribed number and greater than the prescribed number of doses were removed. This definition quantifies daily
adherence without penalizing the patient for removing more than one dose simultaneously. In both cases, poor
adherence is defined as taking less than 80% of the prescribed doses, because this rate is considered necessary for
antihypertensive medications to be effective [47], and has been used in other adherence trials [16].

2.6.1.2. Self-report measure of adherence. In both groups, self-reported adherence to prescribed antihypertensive
medications is assessed at baseline and each follow-up visit with the aid of a well validated 4-item scale developed by
Morisky et al. [43,48]. This scale specifically addresses medication-taking in hypertensive patients. In one study of 88
hypertensive patients, it was found to have a sensitivity of 72% with a specificity of 74% for adherence to at least 80%
of prescribed medications [43]. 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 a higher score indicating poorer adherence. In addition patients who respond yes to any of the
items are categorized as nonadherent. As such, self-reported adherence is assessed as both a continuous and a
categorical measure.

2.6.2. Secondary outcomes

The secondary outcomes are within-patient changes in both SBP and DBP, and within-patient changes in self-
efficacy and intrinsic motivation scores from baseline to 12 months.

2.6.2.1. Within-patient change in SBP and DBP. Clinic BP readings were extracted from the patients' medical
records at baseline and at the 12 month visit. The within-patient change in BP for each patient is computed from the
difference in BP between the baseline and the 12-month BP reading from the formula:

Baseline BP12  month BP reading Change in BP reading:

This measure is computed for each patient and the average for each study group is calculated. This is carried out
separately for both SBP and DBP.

2.6.2.2. Within-patient change in self-efficacy score. Given that self-efficacy is behavior specific, this study utilizes
a scale targeted at adherence to antihypertensive medications. This is a 26-item self-efficacy scale with adequate
reliability and testretest properties in a similar group of hypertensive African American [49]. 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 4-point Likert response format. The response options for each item are 1 = not at all sure,
2 = somewhat sure, 3 = very sure, and 4 = extremely sure. A summary score is computed by summing the responses,
with higher scores reflecting high self-efficacy. Self-efficacy was assessed at baseline and 12 months and the within
patient-change in self-efficacy score was computed for each patient as the difference in the score between both time
points.

2.6.2.3. Within-patient change in intrinsic motivation. Intrinsic motivation was assessed with the Treatment Self-
Regulation Questionnaire (TSRQ), which assesses the degree to which one's motivation for a particular behavior is
relatively autonomous or self-determined [50]. Patients are provided with 15 reasons why they may or 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
being very true. Patients are characterized with respect to their intrinsic motivation scores at baseline and at and
 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181 175

12 months, and the within patient-change in TSRQ score was computed for each patient as the difference in the score
between both time points.

2.6.3. Psychosocial and other covariate measures

2.6.3.1. Social support. Social support has been shown to be have a positive relationship with medication adherence
[51] [the primary outcome of this study]. Social support was assessed with the Duke Social Support and Stress Scale
(DUSOCS), a valid and reliable 24-item questionnaire that that measures two dimensions of social support: network
and perceptual. The social support component contains 12 items, which are self-administered or interviewer admi-
nistered. Respondents rate the amount of support they receive from six categories of people (for example, significant
other, parents, and coworkers). Scores are calculated to provide information about the perceived amount of support
available, and the sources and size of the support network. Overall scores range from 0 (no support) to 100 (most
support). Reliability tests have found a Cronbach's alphas of 0.71 for family support and 0.70 non-family support. The
2-week testretest correlations were 0.76 for family support and 0.67 for non-family support [52,53].

2.6.3.2. Depression. A meta-analysis showed that depression is a predictor of nonadherence to medical recom-
mendations such that the odds are 3 times greater that depressed patients will be nonadherent compared to non-
depressed patients [51]. Depressive symptoms were assessed with the aid of the Center for Epidemiologic Studies
Depression (CES-D) scale, a reliable, and well-validated 20-item, self-report depression scale [54]. It is scored as a
continuous measure ranging from 0 to 60 with a threshold of 16 or greater indicative of depression. The CES-D has
been widely used in prior studies of patients with cardiovascular diseases [55].

2.6.3.3. Medical comorbidity. Patients' history of comorbidity is documented using Charlson comorbidity index,
which is a validated and widely used weighted-index designed to evaluate the longitudinal risk of mortality attributable
to comorbid disease [56].

2.7. Statistical power

The primary outcome is patient adherence to prescribed antihypertensive medication as determined by Medication
Event Monitoring System (MEMS). Based on literature review, we estimate that the rate of medication adherence will
improve in the control group to 30% due to study participation and the effect of MEM [57]; hence the expected
outcome rate in the control arm; Pc is taken to be 0.30. An increase in the rate of adherence to 60% in the experimental
group will be expected, Pe = 60%. Therefore, the delta (where delta = Pc Pe) is taken to be 0.30. The improvement in
the adherence status of the intervention arm by a differential of 30% was based on the summary of the meta-analysis
conducted by Haynes et al. in 1996 [58]. With 80% power and level of significance = 0.05, 86 patients are needed in
each group, for a total of 173 patients, to detect the expected between group difference in medication adherence of 30%.
Accounting for a 10% dropout and lost to follow-up rate, 95 patients were estimated to be needed in each group for a
total of 190 patients.

2.8. Planned statistical analyses

The initial plan was to recruit all 190 patients from one primary care practice, but we had to enroll patients from a
second primary care practice in order to fulfill our enrollment target. Of the 190 patients, 83% were from the original
primary care practice with the remaining 17% from the additional primary care practice. Both sites are within the
Columbia University Ambulatory Care Network. As such, we do not expect this to influence the results in any manner.
Though we have no power to detect any practice-based differences, we will stratify analysis by site to see if any
differences exist.

2.8.1. Primary analyses

The rate of adherence at 12 months will be examined according to the intention-to-treat principle. Adherence
will be measured as a dichotomous variable: adherent or not adherent. A logistic regression will be performed
using the final assessment of adherence as a response and randomization group as a predictor. Other variables
176 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

Fig. 1. Console flow chart.

that may potentially have an effect on adherence such as age, gender, level of education, presence of medical
comorbidity, social support, and depression will be included if these variables are not balanced between groups
by the randomization or if they are determined by univariate analysis to be significantly predictive of adherence.
To capture the potential within-patient variation in adherence, we will use a generalized linear model with a logit
link and repeated measures of adherence.

2.8.2. Secondary analyses

We will assess the effect of the intervention on several secondary outcomes including within-patient change in SBP,
DBP, self-efficacy, and intrinsic motivation. All of these measures will be assessed as continuous variables. For this
purpose, a multiple linear regression will be performed with each of these variables as a response and randomization
group as a predictor. Potential covariates such as age, gender, change in medication, previous MI, stroke, baseline BP,
depression, social support and comorbidity will also be included if these variables are not balanced between groups by
the randomization or if they are determined by univariate analysis to be predictive of changes in blood pressure.
 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181 177

3. Results

3.1. Recruitment

Baseline assessments were completed between July 2002 and May 2005; interventions started in October 2002 and
it is ongoing. The 12-month follow-up visits started in July 2003 and are also ongoing. A total of 529 patients were
screened for this study, 330 of which met the eligibility criteria. Of these, 190 patients were enrolled into the trial with
81% from the community-based practice and 19% from the hospital-based practice. The reasons for ineligibility along
with the breakdown of screening in both sites are shown in Fig. 1. To date, 139 patients have completed the study, 62 in
the intervention group and 67 in the usual care group.

3.2. Sample characteristics

To date, recruitment of all 190 patients is complete. There are 15.2% drop out rates overall with about 14.7% in the
intervention group and 15.7% in the control group. Demographic, medical and psychosocial characteristics of the study
participants are shown in Table 2. The mean age of the patients is 54 years, and 85% are female; 17% are married; 77%

Table 2
Baseline characteristics of study participants
Characteristic Value, N (%)
Age S.D. 53.75 (12.07)
Female 162 (85%)
Marital status
Single 84 (44%)
Married 33 (17%)
Separated 58 (31%)
Widower 15 (8%)
Education
Elementary 43 (23%)
High school/GED 85 (45%)
Some college 61 (32%)
Employment status
Employed full time 29 (15%)
Employed part time 13 (7%)
Retired 20 (11%)
Not working 103 (54%)
On disability 25 (13%)
Type of insurance
HMO 13 (7%)
Medicare 22 (12%)
Medicaid 140 (74%)
Self 15 (8%)
Annual income
Unknown 29 (15%)
$20,000 122 (64%)
N$20,000 39 (21%)
CHF 12 (7.27)
Stroke 18 (10.84)
Diabetes 49 (29.52)
Kidney disease 6 (3.61)
Comorbidity
0 35 (18.82%)
12 65 (34.95%)
34 44 (23.66%)
5 42 (22.58%)
Mean Diastolic Blood Pressure ( S.D.) 86.6 (S.D. 11.4)
Mean Systolic Blood Pressure (S.D.) 144.1 (S.D. 19.2)
178 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

had high school or college education; over half of them were unemployed (54%). In terms of clinical information, the
baseline mean SBP obtained from patients' medical records is 144.1 mm Hg (S.D. = 19.2) and the mean DBP is 86.6
(S.D. = 11.4); about 30% had diabetes; 8% had heart failure and 4% had kidney disease. Almost half of the patients
(45%) had a Charlson comorbidity index score N 3 with about 20% reporting some form of target organ damage for
heart failure, kidney disease or stroke.

3.3. Acceptability of motivational interviewing by providers and patients

The physicians in both practices have been pretty supportive of the program. Though physicians were not
interviewed formally about the motivational interview trial, we ask patients who exit the study about their experience
with the intervention. During the exit interviews patients expressed the following barriers to treatment adherence:
structural barriers in terms of inability to get transportation to pharmacies and doctor appointments for refills, financial
barrier for those whose Medicaid insurance is not renewed, forgetfulness, comorbid condition such as depression, and
competing priorities such as life stressors that interfered with their ability to keep a daily routine.

4. Discussion

To date, we have demonstrated the feasibility of conducting a behavioral counseling intervention such as motivational
interviewing in two busy primary care practices with retention rate of over 80% in both study groups 3 years post
randomization. Data from this study will provide information about the effectiveness of motivational interviewing in
improving medication adherence in hypertensive patients who receive care in primary care practices. Motivational
interviewing has gained increased popularity in recent years and is showing promising results in helping people to initiate
and sustain behavioral change, especially in the area of addictive behaviors [5961]. Other areas of health behavior change
where motivational interviewing has been proven effective include behavioral weight control programs among diabetic
patients [27], dietary adherence in patients with hyperlipidemia [34], fruit and vegetable intake in healthy African
Americans [62], and increasing physical activity in a community-based sample [42]. Except for the study by Resnicow et
al. [62] this is the only study that we are aware of that is utilizing motivational interviewing techniques in targeting behavior
change exclusively in African Americans. Thus, this study will provide needed data on the effectiveness of this approach in
this patient population. Additionally, the results of this study should shed light on the potential mechanisms through which
motivational interviewing exerts its effects on behavior change. Specifically, we will test the mediating effects of important
constructs such as self-efficacy and intrinsic motivation on medication adherence. In most of the reviews to date, there is
little data or discussion regarding the potential mechanisms through which motivational interviewing exerts its influence
on the process of health behavior change [5961].
We will like to acknowledge the following limitations of this study: first, this is an effectiveness trial and it would
have been appropriate to evaluate its cost-effectiveness. However, we felt this was rather premature at this stage given
the lack of data on the feasibility and effectiveness of motivational interviewing improving medication adherence in
primary care settings. Such an objective can be assessed in future trials, if findings from this study are positive. Second,
there was no attention control for the usual care group. Since motivational interview entails a considerable amount to
contact with the patients throughout the study, it can be argued that the differential effect may be solely due to attention
rather than the intervention content itself. However, because this is effectiveness rather than an efficacy trial, we opted
for standard usual care as control. That said, it is important to recognize that patients in the control group got matched
attention for assessment of outcomes as well. Third, this study is powered to account for attrition/drop out rate of 10%,
but to date we have exceeded this drop out rate by approximately 6%. As such, this may result in a type-2 error if no
differences are found in the final analysis. Fourth, majority of the patients in this study are women, low income and
African Americans. As such, the findings from this study will only be generalizable to hypertensive African Americans
from low SES levels. However, since this represents the majority of patients seen in Community Health Centers across
the country we believe that the findings will also be generalizable to similar settings.

5. Conclusion

In conclusion, we have described the rationale and design and reported the baseline data for a randomized controlled
trial designed to test the effectiveness of motivational interviewing in improving medication adherence among
 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181 179

hypertensive African Americans who receive care in a primary care setting. Findings from this study should provide
needed insights into the potential mechanisms through which this modality of behavioral counseling operates in
effecting behavior change as well as its effectiveness among African Americans. This study is timely given the
disproportionate prevalence of hypertension and its attendant complications in African Americans compared to whites.
Data from this study will provide needed insights into the role of behavioral interventions in cardiovascular risk
reduction in a primary care setting.

Acknowledgements

We gratefully acknowledge Ken Resnicow, PhD and Denise Ernst, PhD for all of their help with the training of the
research coordinators in motivational interviewing counseling techniques. This study was funded by grants
R01HL069408 and R24HL076857 from the National Lung and Blood Institute, NIH, Bethesda, Maryland.

Appendix A. Description of motivational interview session

Each patient randomized to the intervention attends four motivational interviewing sessions conducted every
3 months for 12 months. The initial session lasts about 45 min. Each follow-up session is identical to the initial
sessions, but the duration will generally be shorter with each lasting up to 25 min. All sessions are conducted by trained
research assistants with the aid of a standardized structured adherence counseling script that was adapted from the work
of Dilorio et al. [45]. It compromises of the following sequential steps:
Assess the patient's motivation and confidence: The trained RA assesses motivation and confidence with the
following questions:

a. On a scale of 1 to 10 (with 10 being the highest), how motivated/interested are you in taking your blood pressure
medication as prescribed?
b. On a scale of 1 to 10 (with 10 being the highest), assuming you want to, how confident are you that you can take
your blood pressure medication as prescribed?

Elicit barriers, concerns and positive self-motivational statements: depending on the patient's response to the
motivation/confidence questions above, the RA then asks the patient the following questions:

a Why did you not choose a lower number, like a 1 or 2? (this elicits positive motivational statements), and;
b Why did you not choose a higher number? (this elicits barriers) or what will it take to get you to a 9 or 10?

Summary of pros and cons: The RA next summarizes the patient's pros and cons, and asks if there was anything else
that s/he wanted to add.
Provide menu of options: If barriers were presented, the RA then prompts the patient to offer solutions. After the
patient has exhausted his/her own solutions (or in the event that none were offered), the RA seeks permission to list
other solutions that have worked for other people. For those patients without barriers, there is a branch in the script
that encourages them to maintain their behavior.
Assess patient's values and goals: Patients are asked to complete a values-clarification list to help link their
medication adherence and health to other core values and life goals. This helps to create ambivalence between current
behavior and goals and values. Patients are asked to sort a list of approximately 29 values in terms of personal
importance and to select around 5 that are most important. They are then asked to briefly discuss why the values/goals
selected are important to them and then they explore what connection if any, they see between their current health
behavior and their ability to achieve these goals or live out these values. Alternatively, the RA may ask how changing
their health behavior may be related to these goals or values.1

1
Patients are asked to sort a list of approximately 29 values in terms of personal importance and to select around 5 that are most important. They
are then asked to briefly discuss why the values/goals selected are important to them and then they explore what connection if any, they see between
their current health behavior and their ability to achieve these goals or live out these values. Alternatively, the counselor may ask how changing their
health behavior may be related to these goals or values.
180 G. Ogedegbe et al. / Contemporary Clinical Trials 28 (2007) 169181

Clarify contract and global summary: The encounter, when appropriate, ends with a behavioral contract for the
patient to try at least one of the solutions offered. Again the RA summarizes what was agreed upon and incorporates
patients' suggestions.

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