Tailored Behavioral Intervention

Effectiveness of a Tailored Behavioral Intervention

to Improve Hypertension Control
Primary Outcomes of a Randomized Controlled Trial
Jennifer P. Friedberg, Maria A. Rodriguez, Michelle E. Watsula, Iris Lin, Judith Wylie-Rosett,
John P. Allegrante, Stuart R. Lipsitz, Sundar Natarajan

See Editorial Commentary, pp 273–275

Abstract—Blood pressure (BP) control rates are suboptimal. We evaluated the effectiveness of 2 behavioral interventions
to improve BP control via a 3-arm, randomized controlled trial of 533 adults with repeated uncontrolled BP, despite
antihypertensive drug treatment for ≥6 months. The interventions were a tailored stage-matched intervention (SMI) or a
nontailored health education intervention (HEI) of 6 monthly calls targeting diet, exercise, and medication. Control was usual
care (UC). There were no baseline group differences. Baseline BP control was 42.6%, 40.6%, and 44.6% in SMI, HEI, and
UC (P=0.74), respectively; systolic BP (with SEs) was 136 (0.89), 137 (1.33), and 137 (0.96) mm Hg. Six-month control was
64.6% (SMI), 54.3% (HEI), and 45.8% (UC) (P values for pairwise comparisons versus UC, 0.001 [SMI] and 0.108 [HEI]).
At 6 months, systolic BP (SE) was 131.2 (1.05), 131.8 (0.99), and 134.7 (1.02) for SMI, HEI, and UC, respectively (P values
for pairwise comparisons versus UC, 0.009 for SMI and 0.047 for HEI). SMI led to lower systolic BP and better BP control
than UC. SMI constitutes a new, potent approach to assist patients with uncontrolled hypertension to reach BP goals.
 Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00286754.
(Hypertension. 2015;65:440-446. DOI: 10.1161/HYPERTENSIONAHA.114.03483.
Key Words: diet ◼ exercise ◼ hypertension ◼ randomized controlled trial
Downloaded from http://ahajournals.org by on September 24, 2021

M ore than 65 million American adults have hyperten-

sion.1 Diet, exercise, and drugs are mainstays of hyper-
tension management.2 The efficacy of hypertension treatment
counseling offers a promising alternate approach,10 and such
counseling can be delivered at a convenient time and setting.11
Telephone interventions have improved medication adher-
in preventing cardiovascular events is established.2 Although ence,12,13 physical activity,14 and diet,15 all key to lowering BP. It
the system and provider interventions have improved blood is not known, however, whether novel theory-based behavioral
pressure (BP) control rates from the previous low rate (27%3) interventions can be delivered by telephone and whether they
to more respectable rates (51%1 to 79%4,5), the substantial pro- are effective in busy, clinical settings.
portion remains uncontrolled. However, we may have reached We conducted a randomized controlled trial to evaluate the
the maximum control achievable with nontailored interven- effectiveness of targeting patients with repeated uncontrolled
tions targeting clinics or hospitals with growing concerns that hypertension with either a tailored or a nontailored intervention
such interventions may lead to overtreatment and adverse out- in improving hypertension control and systolic blood pressure
comes.4,6 To optimize hypertension control further, approaches (SBP).
to identify and target patients at risk, to whom appropriately
tailored therapy can then be offered, are needed. Methods
Suboptimal adherence is a common, but modifiable, problem Design, Setting, and Participants
leading to inadequate hypertension control. Fewer than 10% The study was a randomized controlled trial to evaluate whether a
of adults with hypertension adhere fully to diet recommenda- telephone-delivered, behavioral stage-matched intervention (SMI) or
a nontailored health education intervention (HEI) would lead to bet-
tions,7 ≈35% exercise regularly,8 and only 50% to 60% are fully ter BP control than usual care (UC) in patients with uncontrolled BP.
medication adherent.9 In-person counseling to improve adher- The study was approved by the institutional review board. All
ence requires time and is labor-intensive and costly. Telephone participants provided written informed consent. Procedures were

Received March 5, 2014; first decision March 24, 2014; revision accepted October 23, 2014.
From the Research and Development Service (J.P.F., M.A.R., M.E.W., I.L.) and Medical Service (S.N.), VA New York Harbor Healthcare System, NY;
Departments of Medicine (J.P.F., S.N.) and Psychiatry (J.P.F.), New York University School of Medicine, NY; Department of Epidemiology and Population
Health, Albert Einstein College of Medicine, Bronx, NY (J.W.-R.); Department of Health Education, Teachers College and the Mailman School of Public
Health, Columbia University, New York, NY (J.P.A.); and Departments of Medicine and Surgery, Brigham and Women’s Hospital, Harvard Medical
School, Boston, MA (S.R.L.).
Reprint requests to Sundar Natarajan, 423 East 23rd St, Room 15160-N, New York, NY 10010. E-mail [email protected]
© 2014 American Heart Association, Inc.
Hypertension is available at http://hyper.ahajournals.org DOI: 10.1161/HYPERTENSIONAHA.114.03483

440
 Friedberg et al   Intervention to Improve Hypertension Control   441

followed in accordance with institutional guidelines. We recruit- vegetables, and low-or nonfat dairy products) ≥6 days/wk. Specific
ed participants from July 2006 to March 2009 in Veterans Affairs recommendations, such as trimming visible fat from meat and ask-
Medical Center clinics in Brooklyn and Manhattan. Follow-up was ing for sauces on the side in restaurants were provided each month,
completed in August, 2010. Patients with uncontrolled BP during and any additional dietary questions were answered. The interven-
their previous visit were approached during their subsequent visit and tion was tailored to target personal barriers and brainstorm solutions.
invited to participate. Patients were eligible if they had hypertension,2 Medication adherence was defined as the self-report of taking BP
antihypertensive drug therapy for ≥6 months, and uncontrolled BP medications as prescribed for ≥6 days/wk. Although refill compliance
during screening. Uncontrolled BP was defined as SBP ≥130 mm Hg was measured, the stage of change only took self-reported adherence
or diastolic BP ≥80 mm Hg in diabetes mellitus (DM) or chronic kid- into account. Exercise adherence was defined as self-reported aerobic
ney disease, or SBP ≥140 mm Hg or diastolic BP ≥90 mm Hg in all exercise for ≥3 days/wk for ≥20 minutes each time. We used the low-
others as per the BP guidelines at the time of the study. er threshold for exercise adherence19,20because of our patient popula-
Patients with cardiovascular disease diagnosed <6 months ago, tion with multiple comorbidites, consistent with Federal guidelines
class III or IV heart failure, severe psychiatric illness, AIDS, tuber- for older adults with chronic conditions.21 Patients received tailored
culosis, lupus, end-stage renal failure, or limited life expectancy (<1 counseling for each target behavior based on their current stage of
year) were excluded because of terminal illnesses. Other exclusions change. SMI used the processes of change using the cognitive and
included lack of a telephone, inability to follow the study protocol, behavioral activities found to be most effective for each stage,22,23
recent major surgery (<3 months), those temporarily in the area or and incorporated decisional balance and self-efficacy. For the deci-
not available for follow-up, or inability to provide informed consent. sional balance, the pros and cons of each behavior were elicited, and
After enrollment, veterans had a simple “run-in period” of 4 weeks the counselor explored why each pro endorsed was important to the
during which we confirmed their telephone availability and reminded participant. For each con, alternatives were explored using problem-
them about the study and visits.16 After the run-in, participants visited solving methods. Similarly, for self-efficacy, the counselor worked
the clinic for the baseline assessment where a research assistant mea- with the participant to enhance confidence in ability to adhere.
sured BP 6× for 2 hours using an Omron HEM-907XL automated BP Patients in HEI had monthly telephone counseling (≈15 minutes)
machine. The cuff was placed on the participant’s right upper arm, of standard, nontailored information about hypertension, and diet,
with the bottom of the cuff placed ≈1″ above the crook of the elbow. medication, and exercise guidelines for hypertension from American
The standard-sized cuff (9″–13″) was used for most participants; if Heart Association educational materials. Although HEI did not take
there was doubt about cuff size, arm circumference was measured. the stage of change into account, it was still interactive in encour-
Height and weight were measured, and questionnaires were adminis- aging the participants to ask questions. Because the HEI is shorter
tered. Participants also completed laboratory tests. A similar protocol than the SMI, we included education on other healthful behaviors
was followed for 6 months. Participants received $20 for their time (expanded hypertension information; sun safety; flu prevention; sleep
and travel for each study visit. hygiene; back injury prevention; and vision and hearing) to increase
After the baseline, participants were allocated to the 3 study arms the duration of attention provided.
by block randomization stratified by the site and dietary adherence.
The randomized assignments were concealed and computer-gener-
ated randomization was performed by the research coordinator, who
Other Measurements
Participants were categorized as having DM, chronic kidney disease,
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was neither involved in assessment nor counseling.17 Participants

knew that we were evaluating whether telephone interventions im- or other comorbidities using established criteria. DM was determined
prove hypertension management, but they did not know which active by chart review. Anyone with an estimated glomerular filtration rate,
telephone arm they were in. Counselors knew the treatment assign- calculated using the MDRD equation, of ≤60 was considered to have
ments, but did not know the BP and adherence outcomes. Research chronic kidney disease. Smoking, race, marital status, education, and
assistants were blinded to treatment assignment.17 Random assign- employment were obtained by questionnaire. The number of antihy-
ment was made by computer-generated randomization (using statis- pertensive medications and antihypertensive medication intensifica-
tical analysis system) to each treatment group by permuted blocks tion (dose and number) was obtained from electronic medical records
of size 6 by the site. For all consecutive blocks of size 6 in a site, 2 and confirmed by the self-report.24 Exercise was obtained from
subjects were in each of the 3 treatments. Patients received a phone physical activity recall25 and medication adherence from the Morisky
call from the counselor to schedule the first session 7 days after the adherence scale,26 a 4-item questionnaire scored from 0 to 4; scores
baseline if randomized to SMI or HEI. <4 are defined as nonadherent. Diet was assessed using the Willett
Food Frequency Questionnaire and adherence was summarized using
the dietary approaches to stop hypertension score, which ranges from
Intervention 8 to 40, with higher scores representing greater adherence.
All participants received standard information about hypertension
and its treatment at enrollment. The UC group received no coun-
seling. SMI and HEI received monthly telephone counseling for 6 Statistical Analyses
months. All telephone sessions were conducted by counselors with a The primary end points were BP control (dichotomous) and SBP
Master’s degree or higher in psychology or social work who were not (continuous). The study was designed as an effectiveness trial of 2
involved in recruitment or assessment visits. Participants were ran- active interventions, each compared with an active standard of care
domized equally to the counselors with the same call procedures for control group. On the basis of our pilot data and a literature search,
SMI and HEI such that each counselor conducted both HEI and SMI we expected that 54% of patients on BP-lowering therapy would be
calls. Calls were recorded, and a random sample was assessed weekly properly controlled with HEI and 43% with UC, whereas we expected
for treatment fidelity by the PI, research coordinator, and counselors. SMI to increase this to 69% control in 6 months. With a significance
Patients in SMI received tailored monthly phone counseling for level of 0.025 (2-sided type I error rate), it was necessary to recruit
exercise, diet, and medications based on the current stage of change, 149 patients per group in 6 months (ie, 447 in total) to achieve ≥90%
using a computer-based intervention manual. During each call (≈30 power using Pearson χ2 to test for significant differences between the
minutes), the stage of change for adherence to diet, medication, and 3 groups. The study was not powered to test comparisons between the
exercise was assessed separately using the validated stage of change 2 active intervention arms. We controlled the possible clustering of
questions18 and tailored counseling based on this assessment. The patient outcomes by physician in all analyses.27 Patient characteristics
stages of change were precontemplation or no plans to adhere in <6 were compared across treatment arms to assess randomization using
months; contemplation or plans to adhere in 1 to 6 months; prepara- Rao–Scott χ2 tests for categorical variables28 and generalized estimat-
tion or plans to adhere within 1 month; action or adherence for <6 ing equations for continuous variables.
months; and maintenance or adherence for ≥6 months. BP control and SBP were compared at 6 months across treatment
Patients were considered adherent to diet if they reported eating arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25%
the appropriate diet for hypertension (low in salt and fat with fruits, for each of the 4 comparisons (SMI versus UC and HEI versus UC
 442  Hypertension  February 2015

for BP control and SBP separately).29 The BP control analysis com- generalized estimating equations approach31 that yields unbi-
pared the proportions of patients with BP under control at 6 months ased estimates, if the missing data are missing at random.32
across the 3 treatment groups using Rao–Scott χ2 tests accounting for
There were no significant baseline differences between
physician clustering.28 The SBP analysis compared the mean 6-month
SBP across the 3 treatment groups using robust generalized estimating groups (Table 1). There were 71 providers for these 533 par-
equation tests controlling for physician clustering.30 Additional analy- ticipants (mean, 7.5 participants per provider; range 1 per pro-
ses using logistic regression estimated the impact of SMI and HEI vider to 36 per provider).
(versus UC) on BP control among subgroups, via generalized estimat- No significant baseline differences were found between treat-
ing equation to control for clustering by physicians. All analyses used ment groups for BP and BP-related behaviors (Table 2). The
SAS software, version 9.2 (SAS Institute). All P values are 2 sided.
proportion of participants with controlled hypertension at the
baseline among SMI, HEI, and UC was 43%, 41%, and 45%,
Results
respectively (P=0.74). The mean SBP (in mm Hg) was 136.0,
We enrolled 705 individuals with uncontrolled BP at a pre-
137.2, and 137.0 in SMI, HEI, and UC, respectively (P=0.65).
vious clinic visit and uncontrolled BP during screening at a
At 6-month follow-up (Table 3), a significantly greater num-
follow-up visit (Figure 1). After enrollment, 157 dropped out
ber of participants in SMI had controlled BP compared with
during the run-in period becuase of lack of interest or time
participants in HEI or UC, with 64.6%, 54.3%, and 45.8%
(n=61), inability to be contacted (n=75), and occurrence of having controlled BP in SMI, HEI, and UC, respectively. The
exclusionary events, such as myocardial infarction or stroke 6-month mean SBP for each treatment group, adjusted for
(n=21). Another 15 were excluded after the baseline before mean baseline SBP, indicated that patients in SMI had signifi-
randomization because we could not contact them by phone cantly lower mean SBP at 6 months than those in UC (131.2
(n=10) or they became ineligible (n=5). We randomized 533 versus 134.7; P=0.009); HEI had lower mean SBP than UC at
participants of those 481 completed the 6-month visit, result- 6 months (131.8 versus 134.7; P=0.047), although not signifi-
ing in a 6-month missing data rate of <10%. Although this cant when adjusting for multiple comparisons because we use
missing data percentage is small, to ensure study validity in a type I error of 0.0125 to account for the 4 main comparisons.
case data are not missing completely at random, we used a To evaluate the robustness of our findings, we tested
whether the change in BP control and SBP was similar across
arms (Table 3). The changes in BP control and SBP were both
significantly better for SMI than UC. To assess this further,
we tested the null hypothesis of no change in BP control from
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Table 1.  Baseline Characteristics of Participants by

Randomization Group
SMI, HEI, UC,
Characteristic n=176 n=177 n=180 P Value
Age, y, mean (SE) 66.4 (0.66) 66.5 (0.96) 65.4 (0.76) 0.50
Men, % 98.9 99.4 97.7 0.36
Race
 White (nonhispanic) 46.0 33.9 39.6 0.33
 Black (nonhispanic) 36.9 43.3 39.0
 Hispanic 13.6 16.1 15.8
 Other 3.4 6.1 5.7
Married, % 33.5 38.0 39.1 0.58
High school graduate or 40.8 50.3 48.3 0.15
below, %
Employed 16.3 22.9 22.5 0.25
Manhattan campus, % 54.6 54.4 53.7 0.98
BMI, mean (SE) 30.5 (0.38) 31.2 (0.47) 30.0 (0.34) 0.12
Current smoker, % 20.1 18.3 17.9 0.87
Comorbidities
 Diabetes mellitus 40.3 46.7 45.2 0.51
 IHD (heart attack) 13.1 12.2 13.0 0.96
 Revascularization, % 15.3 16.1 17.1 0.93
 Hyperlipidemia, % 22.0 21.6 28.7 0.86
Figure 1. Flow diagram of the progress through the phases  EGFR, mean (SE) 79.9 (1.92) 83.2 (3.48) 80.6 (2.11) 0.74
of the 3-arm parallel randomized controlled trial of adults with
uncontrolled hypertension. BP indicates blood pressure; HEI, BMI indicates body mass index; EGFR, estimated glomerular filtration rate;
health education intervention; SMI, stage-matched intervention; HEI, health education intervention; IHD, ischemic heart disease; SMI, stage-
and UC, usual care. matched intervention; and UC, usual care.
 Friedberg et al   Intervention to Improve Hypertension Control   443

Table 2.  Baseline BP Levels and BP-Related Behaviors was greater after the appropriate diet for hypertension than in
Characteristic SMI HEI UC P Value HEI or UC, and improvement in diet can lower SBP by ≤11
mm Hg.33,34 Although we expected improvement in medication
BP control, % 42.6 40.6 44.6 0.50
adherence, baseline medication adherence was high, and there
Systolic blood pressue, 136.0 (0.89) 137.2 (1.33) 137.0 (0.96) 0.65
was no significant improvement at follow-up.
mm Hg, mean (SE)
Although several studies have focused on improving BP
Diastolic blood pressure, 75.5 (0.70) 76.1 (0.87) 75.0 (0.83) 0.66
using different approaches, the success achieved has been
mm Hg, mean (SE)
modest.35 Our study is unique in focusing on patients with
Aerobic exercise in hours 5.3 (0.61) 4.5 (0.44) 5.0 (0.50) 0.48
repeated uncontrolled BP and ongoing intervention tailoring
per week, mean (SE)
to improve multiple behaviors simultaneously. Furthermore,
DASH score, mean (SE) 23.6 (0.47) 23.8 (0.45) 24.0 (0.42) 0.77
we aimed to improve multiple aspects of dietary behavior
Medication Adherence by 3.4 (0.07) 3.2 (0.05) 3.3 (0.07) 0.45
(sodium, fat, fruits, and vegetables).
Morisky scale, mean (SE)
Although we enrolled patients with 2 consecutive uncon-
Number of antihypertensive 2.7 (0.11) 2.8 (0.10) 2.7 (0.10)
trolled BP measurements on 2 different days, 41% to 45% had
medications, mean (SE)
controlled BP at the baseline. This could be because of regres-
Proportion (%) in action or maintenance
sion to the mean,36,37 provider treatment intensification, pla-
 Diet 39 38 39 0.99 cebo effects, or patient activation after enrollment. The run-in
 Exercise 71 62 60 0.07 period allows us to account for regression to the mean effects.
 Medications 93 96 92 0.42 Other potential confounders should be equally distributed
BP indicates blood pressure; DASH, dietary approaches to stop the between the groups because of randomization. Importantly,
hypertension; HEI, health education intervention; ischemic heart disease; SMI, there were no significant BP differences between groups at the
stage-matched intervention; and UC, usual care. baseline. To reduce the likelihood of bias further, we took pro-
viders into account and controlled for baseline BP in all analy-
the baseline to 6 months within each arm and found that there ses. Although we enrolled patients who were uncontrolled at
was 19.7% improvement in the proportion with controlled BP the baseline, anticipating regression to the mean, our actual
for SMI (P<0.0001), 11.9% for HEI (P=0.012), and 1.3% for power analysis assumed the BP control rate of 43% in UC at
UC (P=0.76). the baseline, which is consistent with what had happened. The
We also examined the effects of the interventions on diet, proportion of dropped out patients was also lesser than what
exercise, and medication adherence across arms (Table 3). The we expected, which improved the power of the study.
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change in mean dietary approaches to stop the hypertension Medication adherence was relatively high. Veterans are well-
score from the baseline to follow-up was 0.69 in SMI, −0.16 educated, they have patient-centered medical homes, and medi-
in HEI, and −0.76 in UC (P values, SMI versus UC, 0.01; HEI cations are almost free for most patients. For all of those reasons,
versus UC, 0.32). The change in hours of exercise, change in
medication adherence tends to be high in veteran patients.
the Morisky score, and antihypertensive medication intensifica-
HEI, the nontailored intervention, did not lead to signifi-
tion (dose and number) across arms was not significant. When
cantly better BP control or lower SBP when compared with
we assessed the proportion in action or maintenance across
UC in the primary analyses. The proportion of patients with
arms, a significantly greater proportion of SMI was in action or
baseline SBP further from normal SBP seemed to be greater in
maintenance at follow-up for diet or exercise in SMI compared
HEI than in SMI and UC patients. The interquartile ranges for
with UC. There was no change for medication adherence.
SBP at the baseline were 126.1–145.7 for SMI, 126.2–148.5
To explore whether the effect of the interventions var-
for HEI, and 127.0–146.5 for UC. Furthermore, the DM prev-
ied among subgroups, we conducted subgroup analyses
alence also seemed greater (but not significantly) in HEI than
(Figure 2). For all subgroups, SMI had higher BP control rates
than UC with the pattern of odds ratios showing a consistent in SMI, so HEI had more participants that needed to reach a
effect of SMI across different characteristics (Figure 2A). lower goal (130/80). This could explain why SBP control did
Participants who were elderly, not working, married, not not significantly improve in HEI versus UC at 6 months in
obese or with cardiovascular disease (or DM) were more the primary analysis. In secondary analyses, when HEI was
likely to have BP under control in SMI compared with UC. compared with UC, it was of borderline significance for the
For HEI (Figure 2B), the magnitude of the effect was consis- change in BP control outcome although it reached significance
tently smaller for HEI versus UC comparisons than for SMI for the change in SBP outcome. Finally, the post hoc prepost
versus UC comparisons (Figure 2A). comparison of BP control and SBP for HEI was significant.
This trial has several strengths. We used a rigorous experi-
Discussion mental design and achieved similar groups by block ran-
This trial evaluated the effectiveness of 2 telephone-delivered domization. A simple run-in period reduced the number of
behavioral interventions on BP control and SBP among adults dropouts after randomization and careful patient monitoring
with repeated uncontrolled hypertension in primary care. with attention to data completion resulted in minimal missing
Among such adults, rates of hypertension control at 6 months data. The statistical inferences were obtained using methods
were higher and SBP was lower in SMI compared with UC. currently recommended for trial analysis. The SMI used the
Our findings can be explained primarily by improvements transtheoretical model to tailor therapy delivered by telephone
in diet. At 6 months, the proportion of participants in SMI monthly with high fidelity among counselors. Finally, we used
 444  Hypertension  February 2015

Table 3.  Effects of Behavioral Interventions on BP Control, Sytolic Blood Pressure, and Mediating Variables
P Value,
Characteristic SMI HEI UC Pairwise Comparisons
Primary analyses
 BP control at 6 mo, % 64.6 54.3 45.8 SMI vs UC, 0.001
HEI vs UC, 0.108
 Systolic blood pressure at 6 mo, mm  Hg, 131.2 (129.1, 133.3) 131.8 (129.9, 133.7) 134.7 (132.7, 136.7) SMI vs UC, 0.009
mean (95% CI) HEI vs UC, 0.047
Secondary analyses
 Change in proportion with BP under 19.7 11.8 1.9 SMI vs UC, 0.0004
control from the baseline to 6 mo, % HEI vs UC, 0.051
 Change in systolic blood pressure (mm  Hg) −4.7 (−6.9, −2.5) −5.4 (−8.5, −2.3) −2.7 (−5, −4) SMI vs UC, 0.007
from the baseline to 6 mo, mean (95% CI) HEI vs UC, 0.009
Diet, exercise, and medication analyses
 Change in DASH score from baseline to 6 mo, 0.69 (−0.1, 1.5) −0.16 (−1.1, 0.8) −0.76 (−1.5, 0) SMI vs UC, 0.013
mean (95% CI) HEI vs UC, 0.318
 Change in number of cardio exercise hours −0.29 (−1.7, 1.1) 0.53 (−0.6, 1.7) −0.43 (−1.4, 0.6) SMI vs UC, 0.880
from baseline to 6 mo, mean (95% CI) HEI vs UC, 0.173
 Change in Morisky score from baseline to 0.25 (0.1, 0.4) 0.25 (0.1, 0.4) 0.14 (0, 0.3) SMI vs UC, 0.306
6 mo, mean (95% CI) HEI vs UC, 0.205
Antihypertensive medication intensification
 % that increased the number of meds or dose 43.8 45.6 40.1 SMI vs UC, 0.99
 % with no change in number of meds or dose 41.5 45.0 49.7 HEI vs. UC, 0.41

 % that decreased the number of meds or dose 14.7 9.4 9.6
Proportion (%) in action or maintenance at 6 mo
 Diet 56 46 43 SMI vs UC, 0.011
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HEI vs UC, 0.638

 Exercise 82 78 74 SMI vs UC, 0.012
HEI vs UC, 0.333
 Medications 95 98 96 SMI vs UC, 0.581
HEI vs UC, 0.502
BP indicates blood pressure; CI, confidence interval; DASH, dietary approaches to stop the hypertension; HEI, health education intervention; ischemic heart disease;
SMI, stage-matched intervention; and UC, usual care.

the mean of 6 BP measurements, consistent with methods behavioral changes, such as modifying dietary habits. This
used in population studies. approach is particularly relevant and timely with the increas-
Our findings should be interpreted taking into account the ing integration and patient-centeredness of healthcare where
study sample and design. Our sample is representative of urban many healthcare organizations have (or are now developing)
veterans with hypertension, ie, being primarily men, older, and infrastructure to support telephone-based care and are poised
with multiple comorbidities. Results might differ in other pop- to intervene advantageously in a standardized way for patients
ulations, eg, among women with hypertension. The Veterans with repeated uncontrolled hypertension. Consequently, we
Health Affairs system is the largest health maintenance orga- believe that this work has important implications for the clini-
nization in the country, and these findings likely can be gen- cal management of hypertension and could serve as a model for
eralized to other managed care settings. Hypertension is a big approaches to other chronic diseases where consistent adher-
issue in nonveterans and non–health maintenance organiza- ence to behavioral regimens is required to produce optimal
tion settings all over the United States as well. The aging of health outcomes and where the failure to do so is associated
the population and the increasing rates of obesity and DM are with the bulk of preventable costs in the US healthcare system.
likely to increase this high prevalence of hypertension further. Although this effectiveness trial was not powered to test
Although gains in hypertension control have been achieved, comparisons between the active intervention arms, the intent
there are concerns that system-wide interventions may lead was that the findings, if both interventions were success-
to overtreatment and potential adverse events. Therefore, an ful, would allow a hospital or a clinic to use the appropri-
approach targeting patients with repeated uncontrolled hyper- ate intervention based on its resources and needs. For some,
tension and tailored counseling the patients’ behaviors to implementing the tailored intervention will be feasible and
improve adherence has great promise. This study provides a justified by local resources and the prevalence of uncontrolled
way to overcome the challenge of motivating patients to make hypertension. Others may not have the expertise to deliver the
 Friedberg et al   Intervention to Improve Hypertension Control   445

nursing, and pharmacy) depending on local resources and

needs. For some institutions, implementing such a program
may be feasible and justified by the volume of uncontrolled
hypertension. An alternative approach is to have a specialized
hub center for a network of hospitals and intervene in a stan-
dardized way for patients with repeated uncontrolled hyper-
tension for the hospitals in a network.
The SMI may be a valuable additional tool to lower BP levels
and improve control. It may also be a useful strategy to enhance
adherence and improve outcomes in other chronic conditions,
such as DM and heart failure, or in those who live further away
and have difficulty attending frequent in-person medical visits.

Sources of Funding
This work was funded by the Department of Veterans Affairs Health
Services Research and Development Service Research Career
Development Award 00-211 (S. Natarajan), Investigator-Initiated
Research 04-170 (S. Natarajan) and Career Development Award 08-009
(J.P. Friedberg).

Disclosures
None.

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Novelty and Significance

What Is New? improvements in BP resulting from SMI are primarily driven by improve-
• This trial evaluated the effectiveness of 2 telephone-delivered behav- ments in diet, which is a difficult area in which to change for many pa-
ioral interventions on blood pressure control (BP) and systolic BP among tients with hypertension. The intervention led to improvements in BP via
adults with repeated uncontrolled hypertension in primary care. It found telephone rather than in-person counseling, which potentially increases
that a telephone-delivered, stage-matched behavioral intervention (SMI) scalability and reduces costs.
led to higher rates of hypertension control and lower SBP at 6 months
compared with usual care. Summary
• This intervention is novel because of its focus on patients with repeated A telephone-delivered SMI resulted in significant clinical and sta-
uncontrolled BP and ongoing tailoring of the SMI to improve multiple tistical improvement in BP at 6 months. This SMI may be a valuable
behaviors simultaneously. additional tool for improving BP control rates.
What Is Relevant?
• Suboptimal adherence to treatment recommendations is a common, but
modifiable, problem that leads to inadequate hypertension control. The