Article

Annals of Internal Medicine

Two Self-management Interventions to Improve Hypertension Control

A Randomized Trial
Hayden B. Bosworth, PhD; Maren K. Olsen, PhD; Janet M. Grubber, MSPH; Alice M. Neary, RN; Melinda M. Orr, MEd;
Benjamin J. Powers, MD; Martha B. Adams, MD; Laura P. Svetkey, MD; Shelby D. Reed, PhD; Yanhong Li, MS; Rowena J. Dolor, MD, MHS;
and Eugene Z. Oddone, MD, MHS

Background: Fewer than 40% of persons with hypertension in the

United States have adequate blood pressure (BP) control.
Objective: To compare 2 self-management interventions for improving BP control among hypertensive patients.
Design: A 2 2 randomized trial, stratified by enrollment site and
patient health literacy status, with 2-year follow-up. (ClinicalTrials
.gov registration number: NCT00123058)
Setting: 2 university-affiliated primary care clinics.
Patients: 636 hypertensive patients.
Intervention: A centralized, blinded, and stratified randomization
algorithm was used to randomly assign eligible patients to receive
usual care, a behavioral intervention (bimonthly tailored, nurseadministered telephone intervention targeting hypertension-related
behaviors), home BP monitoring 3 times weekly, or the behavioral
intervention plus home BP monitoring.

7.6% (CI, 1.9% to 17.0%) in the home BP monitoring

group, and 11.0% (CI, 1.9%, 19.8%) in the combined intervention group. Relative to usual care, the 24-month difference in systolic BP was 0.6 mm Hg (CI, 2.2 to 3.4 mm Hg)
for the behavioral intervention group, 0.6 mm Hg (CI, 3.6
to 2.3 mm Hg) for the BP monitoring group, and 3.9 mm
Hg (CI, 6.9 to 0.9 mm Hg) for the combined intervention
group; patterns were similar for diastolic BP.
Limitation: Changes in medication use and diet were monitored
only in intervention participants; 24-month outcome data were
missing for 25% of participants, BP control was adequate at baseline in 73% of participants, and the study setting was an academic
health center.
Conclusion: Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and
diastolic BP at 24 months relative to usual care.

Measurements: The primary outcome was BP control at 6-month

intervals over 24 months.

Primary Funding Source: National Heart, Lung, and Blood Institute; Pfizer Foundation Health Communication Initiative; and the
American Heart Association.

Results: 475 patients (75%) completed the 24-month BP followup. At 24 months, improvements in the proportion of patients with
BP control relative to the usual care group were 4.3% (95%
CI, 4.5% to 12.9%) in the behavioral intervention group,

Ann Intern Med. 2009;151:687-695.

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For author affiliations, see end of text.
This article was published at www.annals.org on 6 October 2009.

lthough multiple treatment options are available for

hypertension, only one third of U.S. patients with hypertension have their blood pressure (BP) under effective
control (1). Home BP monitoring is a potentially important aspect of successful hypertension management (2).
Adopting a healthy lifestyle and adhering to provider
recommendations are also important in managing hypertension. Few educational and BP monitoring studies
have provided long-term follow-up (12 months) or
implemented a multidimensional intervention that is
tailored to patients needs and delivered by telephone
(3). A tailored telephone behavioral intervention and
home BP monitoring may be a cost-effective method for
improving BP outcomes (4).
We compared the effectiveness of BP self-monitoring,
a tailored, nurse-administered behavior self-management
intervention, and a combination of the 2 interventions
with that of usual care.

METHODS
The study was approved by the Duke University Institutional Review Board, and all patients provided written
informed consent.

Setting and Participants

Recruitment occurred from May 2004 to December

2005, with follow-up from November 2004 to January
2008. Potentially eligible study patients were identified
through weekly data extractions from the billing and appointment database for 2 Duke University Health System
primary care clinics. Patients were cared for by 7 faculty
general internists in 1 clinic and 85 residents under the
supervision of faculty at the other clinic.
Initial inclusion criteria were hypertension diagnosed
at least 12 months before the data extraction date (International Classification of Diseases, 9th revision, codes
401.0, 401.1, or 401.9), enrollment with a primary care
physician at the included clinic for at least 12 months
before data extraction, self-report of current antihyperten-

See also:
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Editors Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 688
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Conversion of graphics into slides
2009 American College of Physicians 687

Article

Self-management Interventions to Improve Hypertension Control

Context
Can self-management interventions help improve blood
pressure control in hypertensive patients?

Contribution
In this trial, 636 patients with hypertension were randomly
assigned to receive usual care; a telephone-delivered,
nurse-administered behavioral self-management intervention; home blood pressure self-monitoring; or both of the
latter 2 interventions. Compared with usual care, the
adjusted improvement in the proportion of patients with
blood pressure control at 24 months was 4.3% for the
behavioral intervention group, 7.6% for the blood pressure monitoring group, and 11.0% for the combined
intervention group.

Caution
Patients were recruited from 2 university-affiliated clinics,
and most (73%) already had reasonable blood pressure
control at trial entry.
The Editors

sive medication use, a scheduled appointment with a nonlaboratory primary care provider during the next 30 days,
and residence in 1 of 32 specified ZIP codes in the areas
around Duke University Health System.
Exclusion criteria applied before randomization were a
diagnosis of dementia, Parkinson disease, atrial fibrillation,
or end-stage renal disease; patient of a study investigator or
physician not expected to remain at the practice during the
entire study period; resident in nursing home or receiving
home health care; hospitalization for stroke or heart attack,
surgery for blocked arteries, or diagnosis of metastatic cancer in the previous 3 months; poor vision or difficulty
hearing on the telephone; difficulty understanding English
on the telephone; participant in another BP study; spouse
participating in current study; arm circumference greater
than 17 inches and wrist circumference greater than 8.5
inches; pregnant or planning to become pregnant in the
next 2 years; or not receiving most medical care from Duke
clinics. Patients also were excluded after randomization because they were no longer receiving medical care at the
Duke clinics, had initiated dialysis, had received an organ
transplant in the previous 6 months, resided in a nursing
home or receiving home health care, had no telephone, or
received a diagnosis of pulmonary hypertension in the previous 6 months.
The study team mailed qualifying patients a letter
from the patients primary care provider that gave information about the study and stated that the study team may
contact them to participate. Research assistants made
weekly screening telephone calls to patients from a randomly ordered list of eligible patients with upcoming
clinic appointments.
688 17 November 2009 Annals of Internal Medicine Volume 151 Number 10

Figure 1 shows the flow of participants in the study.

Overall, 2060 invitation letters were mailed to patients.
Research assistants attempted to contact 1728 potential
participants by telephone. Six hundred fifty-six patients
were enrolled and consented to participate; the remaining 1072 were not enrolled for various reasons. Twenty
additional patients were excluded at the time of the
baseline interview.
Randomization and Intervention

The 636 eligible patients were randomly assigned to

receive usual care, a tailored behavioral telephone intervention, home BP monitoring, or the behavioral intervention
plus BP monitoring. In a 2 2 design, randomization was
stratified at baseline by enrollment site (2 primary care
clinics) and health literacy status, as determined by using
the Rapid Estimate of Adult Literacy in Medicine (5) (low
literacy, score of 0 to 60 [9th-grade level or less] [6], vs.
adequate literacy, score of 61 to 66 [greater than 9th-grade
level] [7]). Consecutively numbered envelopes were used
to randomly assign patients in each stratum. Randomization blocks of 16 were computer generated by the
study statistician and used to ensure ongoing balanced
enrollment across the 4 groups. The research assistants
were blinded to block size, and patient randomization
sequences were maintained by the study statistician in a
separate office from the clinics. At completion of the
baseline interview, a research assistant opened an envelope and disclosed the patients randomization status.
Participants were reimbursed $25 for the baseline visit
and for each of the 4 subsequent 6-month BP measurement visits ($125 total).
Usual Care

Patients assigned to usual care received hypertension

care from their primary care provider. They were not provided home BP monitors and did not have access to the
nurse-administered behavioral intervention. They underwent the same 6-month outcome assessment measurements as the other groups.
Tailored Behavioral Self-management Intervention

Patient factors targeted in the behavioral intervention

included perceived risk for hypertension, memory, literacy,
social support, patients relationships with their health care
providers, and side effects of antihypertension medication.
In addition, the intervention focused on improving adherence to the Dietary Approaches to Stop Hypertension
(DASH) dietary pattern (8 11), weight loss (12, 13), reduced sodium intake (13, 14), regular moderate-intensity
physical activity (15, 16), smoking cessation, and moderation of alcohol intake (17).
The intervention was delivered by 1 nurse during bimonthly telephone calls. All information was presented in
an easily understood format with a FleschKincaid readability score of less than 9th grade (18). Each encounter
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Self-management Interventions to Improve Hypertension Control

Article

Figure 1. Study flow diagram.

Letters mailed to potentially eligible patients

(n = 2060)
Excluded (n = 332)
Not contacted: 331
Died before contact: 1
Screening telephone call attempted
(n = 1728)

Excluded (n = 1072)
Disconnected/incorrect number: 33
Ineligible: 214
Declined to participate: 634
Other reason: 191

Patient consented to participate

(n = 656)
Excluded (n = 20)
Arm size: 18
Poor vision: 1
Not taking antihypertensive medication: 1
Randomly assigned
(n = 636)

Usual care (n = 159)

Behavioral intervention
(n = 160)

Home BP monitoring
(n = 158)

Lost to follow-up (n = 15)

Died (n = 5)
Excluded (n = 4)*
Withdrew (n = 3)

Lost to follow-up (n = 18)

Died (n = 5)
Excluded (n = 7)*
Withdrew (n = 3)

Lost to follow-up (n = 21)

Died (n = 3)
Excluded (n = 5)*
Withdrew (n = 15)

Included in analysis (n = 159

with BPs)
Baseline: 157
6 mo: 144
12 mo: 131
18 mo: 129
24 mo: 128

Included in analysis (n = 159

with BPs)
Baseline: 158
6 mo: 141
12 mo: 135
18 mo: 122
24 mo: 124

Included in analysis (n = 157

with BPs)
Baseline: 156
6 mo: 129
12 mo: 118
18 mo: 112
24 mo: 113

Home BP monitoring plus

behavioral intervention
(n = 159)

Lost to follow-up (n = 22)

Died (n = 2)
Excluded (n = 10)*
Withdrew (n = 12)

Included in analysis (n = 159

with BPs)
Baseline: 158
6 mo: 136
12 mo: 122
18 mo: 105
24 mo: 110

BP blood pressure.
* No longer receiving care at Duke clinics, receiving dialysis, received an organ transplant, residing in a nursing home or receiving home health care, had
no telephone, or had pulmonary hypertension.

included a core group of modules potentially implemented

during each call (for example, medication and side effects)
plus additional modules activated at specific intervals (for
example, diet and social support) (19).
Home BP Monitoring Intervention

Patients assigned to home BP monitoring received an

Omron HEM 773AC arm monitor (OMRON Healthcare, Bannockburn, Illinois) if arm circumference was 17
inches or less or an Omron HEM 637 wrist monitor if arm
circumference was greater than 17 inches and wrist circumference was less than 8.5 inches. Two research assistants
trained patients in proper use of the home BP devices. At
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each 6-month assessment, patients were retrained if

their BP assessment procedure was incorrect. Patients
were asked to measure their BP 3 times weekly on 3
separate days, at the same time of day, and record their
values in a log. Patients were asked to mail their logs in
every 2 months by using study-provided, preaddressed,
stamped envelopes.

Combined Intervention

Patients assigned to the combined intervention received a home BP monitor, training on its use, and the
behavioral self-management intervention. The nurse did
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Self-management Interventions to Improve Hypertension Control

not examine home BP values and did not use the home BP
values to adjust the intervention.
Outcomes and Measurements
Baseline Measurement

Patient demographic information and diagnosis of diabetes were obtained from patients during a face-to-face
baseline interview. Inadequate income was assessed by asking patients to report whether they had enough money to
pay bills only by cutting back on things or had difficulty
paying bills (20). Health literacy was evaluated as a dichotomous variable (7). Body weight abstracted from the medical record and self-reported height were used to calculate
body mass index.

Study Outcomes: BP Control and Systolic and Diastolic BP

The primary outcome was the proportion of participants with adequate BP control at each study time point
(baseline and 6, 12, 18, and 24 months). Blood pressure
control was defined as systolic BP less than 140 mm Hg
and diastolic BP less than 90 mm Hg for patients without
diabetes, and systolic BP less than 130 mm Hg and diastolic BP less than 80 mm Hg for patients with diabetes
(21). Secondary outcomes were systolic and diastolic BP at
each time point over 24 months. At each time point, a
research assistant who was blinded to the patients group
assignment obtained 2 BP measurements with a digital
sphygmomanometer (BPTRU Automated Non-invasive
BP monitor, Model BPM-100, BpTRU Medical Devices
Headquarters, Coquitlam, British Columbia, Canada); the
first was obtained after patients were seated and had rested
for at least 5 minutes, and the second was obtained 30
seconds after the first. The mean of the 2 values was used
as the outcome for that time point.
We collected data on secondary outcomes, including
hypertension knowledge and self-efficacy; however, these
results are not reported here.

Health Care Utilization and Cost

Electronic data on medical resource use in the Duke

University Health System were obtained for all enrolled
patients from randomization through 24 months. These
data included the cost estimates for all health care services.
The cost of each patient intervention encounter was
based on an estimate of annual fixed costs (for example,
office space and telephone) and the nurses salary and assumed that 7 encounters were completed per 6-hour day.
This estimate was assigned to each completed patient encounter. Our cost estimates also included variable costs,
which covered a relatively small amount for patient education materials (for example, paper and toner). Variable
costs for home BP monitoring costs included the cost of
the BP monitor and batteries.
690 17 November 2009 Annals of Internal Medicine Volume 151 Number 10

Follow-up Procedures and Monitoring

We did not anticipate any specific adverse effects of

the intervention. We monitored for cardiovascular adverse
events, such as myocardial infarction, death, and hospitalizations, through medical record and patient report. A data
safety and monitoring board met annually to review all
adverse events.
Statistical Analysis

Sample size estimation was based on the primary hypothesis that patients assigned to an intervention group
would have improved BP control at 24 months compared
with the usual care group. A linear change in BP control
was assumed, so the comparison was a difference in slopes
(the treatment-by-time interaction in a logistic mixedeffects regression model [22]). Sample size and power estimates were generated empirically in a simulation study by
using PROC NLMIXED in SAS, version 9.1 (SAS Institute, Cary, North Carolina). On the basis of previous studies (23, 24), we estimated baseline BP control as 40% and
the 24-month dropout rate as 15%. The random intercept
variance component was assumed to be 0.7 (equivalent to a
patient interclass correlation of 0.18) (22). To detect a
difference in slopes resulting in 10% improvement in BP
control at 24 months with 80% power and a type I error
rate of 5%, 570 patients were needed; however, to account
for dropout, we enrolled 636 individuals.
Primary Analysis

A logistic mixed-effects regression model (22) was used

to estimate change in BP control over time for each intervention group relative to usual care (that is, a difference in
slopes). Observed means and exploratory analyses indicated
that, on average, BP control improved in a linear trend
over time and there were equal correlations between patients repeated measurements. The fixed effects for the
model were coded to reflect the 2 2 factorial design and
included a common intercept (25), the 2 stratification variables, time (in months), and the following interaction
terms: behavioral intervention by month, home BP monitoring by month, and behavioral intervention by home BP
monitoring by month. A random effect was included to
account for the correlation of patients repeated measurements over time. Estimates for the proportion of patients
with BP control for each intervention group and the usual
care group at 12 and 24 months were converted to marginalized probabilities (22). One thousand bootstrap samples were used to derive CIs around the estimated differences of the marginalized probabilities between each
intervention group and the usual care group at 12 and 24
months (26).
Secondary Analyses

For systolic and diastolic BPs, general linear models

(PROC MIXED in SAS, version 9.1) were used to estimate changes in BP over time and to test for BP differences
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Self-management Interventions to Improve Hypertension Control

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Table 1. Patient Characteristics at Baseline

Characteristic*

All Patients
(n 636)

Usual Care Group

(n 159)

Behavioral Intervention
Group (n 160)

Home BP Monitoring
Group (n 158)

Combined Intervention
Group (n 159)

Demographic
Mean age (SD), y
Race
White
African American
Other
Male
Married
Lives alone
Completed 12 y of school
Low health literacy
Employed
Inadequate income
No weekly aerobic exercise lasting 20 min
Current smoker
Mean BMI (SD), kg/m2
Medication nonadherence

61 (12)

62 (12)

60 (13)

62 (12)

61 (12)

48
49
3
34
50
26
36
27
39
19
23
16
32.09 (8.2)
36

45
54
2
36
51
25
35
27
36
20
20
18
32.6 (8.5)
32

43
52
5
33
46
25
34
28
45
18
16
18
32.2 (8.8)
41

50
48
2
29
52
28
40
28
38
21
29
14
31.4 (7.6)
35

56
43
1
38
52
25
36
27
38
18
26
16
32.1 (8.1)
35

Medical history
Started taking BP medication 5 y ago
Parent or sibling has hypertension
Diabetes

60
77
36

59
72
40

62
79
36

56
80
36

63
77
32

BP
Controlled
Mean systolic BP (SD), mm Hg
Mean diastolic BP (SD), mm Hg

73
125 (18)
71 (11)

72
124 (18)
70 (10)

72
124 (18)
71 (10)

77
126 (15)
72 (11)

70
126 (20)
72 (12)

BMI body mass index; BP blood pressure.

* Unless otherwise indicated, data are the percentage of patients. All data except BP and weight used in the calculation of BMI were patient-reported. Missing values were
included in the calculation of percentages.
Less than 9th grade, as indicated by a Rapid Estimate of Adult Literacy in Medicine score 60.
Defined as reporting difficulty paying bills no matter what was done or having money to pay bills only if the patient cut back on spending on other things.
Assessed by using a 4-item measure based on the Morisky scale (33). Response options ranged from strongly agree (1) to strongly disagree (4). A summary binary variable
was created by coding those who responded strongly agree, agree, dont know, or refused to any of the 4 questions as 1 (nonadherent); otherwise, patients received
a value of 0 (adherent).
When patients had multiple BP readings during their baseline visit, mean systolic and mean diastolic readings were used as the baseline BP values.
According to the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines: 140/90 mm Hg
for nondiabetic patients and 130/80 mm Hg for diabetic patients.

in the intervention groups relative to usual care at 12 and

24 months. Exploratory analyses indicated that both systolic and diastolic BPs had quadratic shapes in which improvements in BPs were greatest during the first half of the
study. Predictors in the model were coded to reflect the
2 2 factorial design. The final model included a common intercept, the 2 stratification variables, and the following interaction terms: behavioral intervention by
month, home BP monitoring by month, behavioral intervention by home BP monitoring by month, behavorial intervention by month squared, home BP monitoring by
month squared, and behavioral intervention by home
monitoring by month squared.
Patients were analyzed on the basis of initial randomization group (intention to treat); 634 patients were included in the analyses (Figure 1). All available data, including data from participants who subsequently discontinued
the study, were used for analyses. Our analysis techniques
assumed ignorable dropout, meaning that the probability
of dropout may depend on covariates in the model or participants previous responses but not on current or future
responses (22).
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Role of the Funding Source

The study was funded by the National Heart, Lung,

and Blood Institute; a Pfizer Foundation Health Communication Initiative Award; and an Established Investigator
Award from the American Heart Association to Dr. Bosworth. The funding sources had no role in the study design; data collection; administration of the interventions;
analysis, interpretation, or reporting of data; or decision to
submit the findings for publication.

RESULTS
Patients

Of the 636 study patients, 49% were African American, 66% were female, and 19% reported having inadequate income; the mean age was 61 years (Table 1). At
baseline, mean systolic BP was 125 mm Hg (SD, 18) and
mean diastolic BP was 71 mm Hg (SD, 11). Seventy-three
percent of participants had their BP under control at baseline. Baseline characteristics did not differ meaningfully by
treatment group.
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Figure 2. Changes in study outcomes from baseline to 24

months, by intervention group.
Usual care
Behavioral intervention
Home BP monitoring
Home BP monitoring + behavioral intervention
0.9

With Controlled BP

Estimated Proportion of Patients

1.0

0.8

0.7

0.6

0.5
0

12

18

24

Month

Primary Outcome: BP Control

Systolic BP, mm Hg

135

130

125

120

115
0

12

18

24

Month

The combined intervention had the greatest increase

in the proportion of patients with BP control (Figure 2).
At 24 months, the adjusted improvement compared with
usual care was 11.0% (95% CI, 1.9% to 19.8%; P
0.012) for the combined intervention group, 4.3% (CI,
4.5% to 12.9%; P 0.34) in the behavioral intervention group, and 7.6% (CI, 1.9% to 17.0%; P 0.096)
for the home BP monitoring group. The 3-way interaction
of behavioral intervention by home BP monitoring by
month was not significant (P 0.99), indicating that the 2
interventions did not have a synergistic effect on BP control over time.
Secondary Outcomes
Systolic and Diastolic BP

76
74

Diastolic BP, mm Hg

The 1424 persons who were excluded before random

allocation were similar to study participants in sex (64%
female) and diagnosis of diabetes but were slightly older
(mean age, 63 years) and were more likely to be African
American (57%). No crossover among study groups occurred; however, individuals not assigned to the home BP
intervention groups may have used their own BP monitors.
No study-related adverse events occurred in any intervention group.
Overall, BP measurements were available for 475
(75%) patients at 24 months of follow-up (Figure 1):
81%, 78%, 72%, and 69% of patients in the usual care,
behavioral intervention, home BP monitoring, and combined intervention groups, respectively (P 0.075). Sixtythree percent of patients with lower health literacy and
79% of those with higher health literacy (P 0.001) and
57% of patients at one of the clinics versus 82% at the
other clinic (P 0.001) had BP readings at 24 months.

72
70
68
66

12

18

24

Month

Bars represent 95% CIs. BP blood pressure. Top. Estimated proportion of patients with BP control. Estimates are marginalized probabilities
from a logistic mixed-effects regression model (22). The model-estimated
intrapatient correlation was 0.56. The 95% CIs at 12 and 24 months
were derived from 1000 bootstrap samples. Middle. Estimated mean
systolic BP. Estimates are based on a general linear model with an unstructured covariance matrix. The model-estimated correlation between
time points ranged from 0.41 (baseline and 24 months) to 0.58 (months
6 and 12). Bottom. Estimated mean diastolic BP. Estimates are based on
a general linear model with an unstructured covariance matrix. The
model-estimated correlation between time points ranged from 0.54
(baseline and 24 months) to 0.66 (baseline and 6 months).
692 17 November 2009 Annals of Internal Medicine Volume 151 Number 10

The largest sustained improvement for systolic and diastolic BP was observed in the combined intervention
group (Figure 2). The 3-way interaction of behavioral intervention by home monitoring by month squared was
significant (P 0.041 for the systolic BP model; P
0.004 for the diastolic BP model), indicating that the main
effects of home BP monitoring and the behavioral interventions on BP over time enhanced one another (Table 2).
Figure 2 shows the changes in BP over time. At 12
months, the mean systolic BP was lower by 1.6 mm Hg
(CI, 3.9 to 0.7 mm Hg; P 0.174) in the behavioral
intervention group, 3.7 mm Hg (CI, 6.1 to 1.2 mm
Hg; P 0.004) in the home BP monitoring group, and
3.3 mm Hg (CI, 5.7 to 0.8 mm Hg; P 0.009) in the
combined intervention group than the usual care group.
However, by 24 months, the mean systolic BP was statistically significantly lower only in the combined intervention group than in the usual care group, indicating the
synergistic effect of the 2 interventions on improving BP
over time. Compared with the usual care group, the adjusted 24-month difference in systolic BP was 0.6 mm Hg
(CI, 2.2 to 3.4 mm Hg; P 0.67) in the behavioral
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Table 2. Changes in BP Control and Systolic and Diastolic BP at 12 and 24 Months

Outcome and Time Point

Difference Versus Usual Care Group (95% CI)

Behavioral Intervention
Group

Primary outcome
Patients with controlled BP, %*
12 mo
24 mo
Secondary outcomes
Systolic BP, mm Hg
12 mo
24 mo
Diastolic BP, mm Hg
12 mo
24 mo

2.1 (2.2 to 6.2)

4.3 (4.5 to 12.9)

Home BP Monitoring
Group

3.8 (1.1 to 8.5)

7.6 (1.9 to 17.0)

Combined Intervention
Group

5.6 (0.9 to 10.2)

11.0 (1.9 to 19.8)

1.6 (3.9 to 0.7)

0.6 (2.2 to 3.4)

3.7 (6.1 to 1.2)

0.6 (3.6 to 2.3)

3.3 (5.7 to 0.8)

3.9 (6.9 to 0.9)

1.4 (2.6 to 0.1)

0.4 (1.1 to 1.9)

3.1 (4.4 to 1.8)

1.2 (2.9 to 0.4)

2.2 (3.5 to 0.8)

2.2 (3.8 to 0.6)

BP blood pressure.
* Estimates are marginalized probabilities from a logistic mixed-effects regression model (22). Positive values reflect improvement compared with usual care, and negative
values reflect worsening. The model-estimated intrapatient correlation was 0.56. The 95% CIs were derived from 1000 bootstrap samples.
Estimates are based on a general linear model with an unstructured covariance matrix. The model-estimated systolic BP correlation between time points ranged from 0.41
(baseline and 24 mo) to 0.58 (6 and 12 mo), and the model-estimated diastolic BP correlation between time points ranged from 0.54 (baseline and 24 mo) to 0.66 (baseline
and 6 mo).

intervention group, 0.6 mm Hg (CI, 3.6 to 2.3 mm

Hg; P 0.69) in the home BP monitoring group, and
3.9 mm Hg (CI, 6.9 to 0.9 mm Hg; P 0.010) in
the combined intervention group.
Compared with the usual care group at 12 months,
the mean diastolic BP was lower by 1.4 mm Hg (CI, 2.6
to 0.1 mm Hg; P 0.030) in the behavioral intervention group, 3.1 mm Hg (CI, 4.4 to 1.8 mm Hg; P
0.001) in the home BP monitoring group, and 2.2 mm Hg
(CI, 3.5 to 0.8 mm Hg; P 0.001) in the combined
intervention group (Figure 2). Similarly to systolic BP, the
synergistic effect of the combined intervention on diastolic
BP was evident by the end of follow-up. Compared with
that in the usual care group, the adjusted 24-month
difference in diastolic BP was 0.4 mm Hg (CI, 1.1 to
1.9 mm Hg; P 0.61) in the behavioral intervention
group, 1.2 mm Hg (CI, 2.9 to 0.4 mm Hg; P
0.132) in the home BP monitoring group, and 2.2
mm Hg (CI, 3.8 to 0.6 mm Hg; P 0.009) in the
combined intervention group.
Adherence

Behavioral Self-management Intervention. The nurse

completed 1682 telephone calls to the 160 patients assigned to the behavioral intervention. The mean number
of completed calls per patient was 11 (SD, 2) of a possible
12, and the mean call length was 16 minutes (SD, 7).
Home BP Monitoring. Of the 158 patients assigned to
the home BP monitoring intervention, 91% of patients in
the first 2 months of the study and 64% of patients in the
last 2 months turned in BP logs with at least 1 recorded BP
reading. The percentage of patients who turned in their
logs was higher among patients who completed the study.
Combined Intervention. Of the 159 patients assigned to
the combined intervention group, 89% and 59% turned in
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BP logs with at least 1 recorded BP reading for the first and

last 2 months of the study, respectively; these proportions
were 99% and 81%, respectively, for the 110 patients with
a BP measurement at 24 months. Nurses completed 1589
telephone calls to 156 patients; the mean number of completed calls per patient was 10 (SD, 3) of a possible 12, and
the mean call length was 16 minutes (SD, 7).
Medical Resource Use and Costs

The number of outpatient encounters over 24 months

was similar for the 4 groups; medians ranged from 13 to 15
(P 0.73). The proportion of hospitalized individuals did
not differ (range, 19.5% to 22.6%; P 0.91). The mean
2-year medical cost across the groups was $15 641 (SD,
$25 769; median, $6698).
Intervention Cost Analysis

Intervention costs over 2 years were estimated to be

$345 for the behavioral intervention, $90 for home BP
monitoring, and $416 for the combined intervention (not
including patient time costs). In sensitivity analyses, the
mean cost to implement the combined intervention ranged
from $208 to $811 per patient, depending on assumptions
regarding the mean time between successful encounters
and various direct costs of implementing the intervention.
Additional Analyses

We examined self-reported medication adherence

and exercise at 6 and 24 months of follows-up; however,
although there were trends indicating improvement over
time, changes in the intervention groups compared with
the usual care group were not generally statistically
significant.
17 November 2009 Annals of Internal Medicine Volume 151 Number 10 693

Article

Self-management Interventions to Improve Hypertension Control

DISCUSSION
We examined the effects of a patient behavioral intervention delivered by telephone, home BP monitoring, and
a combination of these interventions in improving BP
among hypertensive adults treated in primary care. Neither
intervention alone improved BP control at 24 months;
however, the combination intervention resulted in a clinically significant improvement in BP control of 11% compared with usual care. Patients in the combined intervention group also had a clinically meaningful decrease in
systolic BP of 3.9 mm Hg compared with the usual care
group. These effects were observed with a brief telephone
intervention that was implemented bimonthly and the use
of home BP monitors, which required minimal patient
training (5 minutes every 6 months).
Home BP monitoring alone has been well studied as a
method to improve BP control. Its main effect is thought
to be on BP recognition, which may lead to improved
adherence and better control. Our results regarding home
BP monitoring are consistent with those of a meta-analysis
of 18 randomized, controlled trials that compared home
BP monitoring with usual care and found that home BP
monitoring resulted in small improvements in BP (reduction of 2.2/1.9 mm Hg) (27). A decrease in BP may encourage the patient to continue treatment, whereas continued high BP readings may encourage appropriate changes
in lifestyle or therapy (28) and faster changes to medical
regimens (29).
A literature search through June 2009 using the terms
self-management and behavior intervention yielded 7 randomized, controlled trials. These trials reported mean differences in systolic BP ranging from 15.7 to 0.6 mm Hg
(30) and had an average follow-up of less than 12 months.
However, the trials involved in-person contact, which potentially reduces scalability and increases intervention costs.
In a review of 10 studies testing mostly in-person behavioral interventions, results favored counseling over usual
care, with improvements of 11.1 mm Hg in systolic BP
and 3.5 mm Hg in diastolic BP (31). Few studies have
implemented a multidimensional intervention that is tailored to patients needs and delivered by telephone, yet
based in primary care practices. Furthermore, few studies
have examined changes in BP for longer than 12 months,
which was particularly relevant in our study; the effects of
using home BP monitors at 12 months indicated an almost
4 mm Hg decrease in systolic BP, but these findings dissipated by 24 months for all but the combined intervention group. The combined intervention did not increase
health care use, and its cost was approximately $400 for 2
years.
The patient self-management intervention was effective only when combined with home BP monitoring. One
proposed explanation is that self-management may be most
effective when it includes ongoing disease monitoring by
694 17 November 2009 Annals of Internal Medicine Volume 151 Number 10

patients that creates the opportunity to respond to new

information (32).
Our study had limitations, 2 of which were the high
rate of BP control (73%) in the study population at baseline and the academic health center setting. The relationship between BP and cardiovascular risk is continuous, and
BP reductions translate to reductions in clinical events,
even with observed relatively low baseline BP (21).
Changes in process measures, such as medication use and
salt intake during the trial, were measured only in the intervention groups. Finally, 25% of the sample was not
available at 24 months; however, we used mixed-effects
models as our primary analysis tool, which includes all
patients with any BP measurements and leads to valid
inferences.
In conclusion, the combination of home BP monitoring and a tailored brief behavioral intervention resulted in
a clinically and statistically significant improvement in BP
control and decreased systolic and diastolic BPs at 24
months, at minimal cost. This combination may be a valuable tool for improving BP control rates.
From the Center for Health Services Research in Primary Care, Durham
Veterans Affairs Medical Center, Center for Aging and Human Development, Duke Hypertension Center, and Duke Clinical Research Institute, Duke University, Durham, North Carolina.
Disclaimer: The views expressed in this manuscript are those of the
authors and do not necessarily represent the views of the Department of
Veterans Affairs.
Grant Support: By grant R01 HL070713 from the National Heart,
Lung, and Blood Institute; a Pfizer Foundation Health Communication
Initiative Award; and an Established Investigator Award from the American Heart Association (Dr. Bosworth).
Potential Conflicts of Interest: None disclosed.
Reproducible Research Statement: Study protocol and data set: Available

from Dr. Bosworth (e-mail, hayden.bosworth@duke.edu). Statistical

code: Available from Dr. Olsen (e-mail, maren.olsen@duke.edu).
Requests for Single Reprints: Hayden B. Bosworth, PhD, Center for
Health Services Research in Primary Care, Duke University, 2424 Erwin
Road, Hock Plaza, Durham, NC 27703; e-mail, hayden.bosworth@duke
.edu.

Current author addresses and author contributions are available at www

.annals.org.

References
1. Ong KL, Cheung BM, Man YB, Lau CP, Lam KS. Prevalence, awareness,
treatment, and control of hypertension among United States adults 1999-2004.
Hypertension. 2007;49:69-75. [PMID: 17159087]
2. Pickering TG, Miller NH, Ogedegbe G, Krakoff LR, Artinian NT, Goff D.
Call to action on use and reimbursement for home blood pressure monitoring: a
joint scientific statement from the American Heart Association, American Society
of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension. 2008;52:10-29. [PMID: 18497370]
3. Morisky DE, DeMuth NM, Field-Fass M, Green LW, Levine DM. Evaluwww.annals.org

Self-management Interventions to Improve Hypertension Control

ation of family health education to build social support for long-term control of
high blood pressure. Health Educ Q. 1985;12:35-50. [PMID: 3980239]
4. Schroeder K, Fahey T, Ebrahim S. How can we improve adherence to blood
pressure-lowering medication in ambulatory care? Systematic review of randomized controlled trials. Arch Intern Med. 2004;164:722-32. [PMID: 15078641]
5. Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns.
1999;38:33-42. [PMID: 14528569]
6. Parker RM, Baker DW, Williams MV, Nurss JR. The test of functional
health literacy in adults: a new instrument for measuring patients literacy skills. J
Gen Intern Med. 1995;10:537-41. [PMID: 8576769]
7. Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and
health outcomes: a systematic review of the literature. J Gen Intern Med. 2004;
19:1228-39. [PMID: 15610334]
8. Karanja NM, Obarzanek E, Lin PH, McCullough ML, Phillips KM, Swain
JF, et al. Descriptive characteristics of the dietary patterns used in the Dietary
Approaches to Stop Hypertension Trial. DASH Collaborative Research Group. J
Am Diet Assoc. 1999;99:S19-27. [PMID: 10450290]
9. Sacks FM, Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP,
et al. A dietary approach to prevent hypertension: a review of the Dietary Approaches to Stop Hypertension (DASH) Study. Clin Cardiol. 1999;22:III6-10.
[PMID: 10410299]
10. Svetkey LP, Sacks FM, Obarzanek E, Vollmer WM, Appel LJ, Lin PH,
et al. The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-sodium): rationale and design. DASH-Sodium Collaborative Research Group. J
Am Diet Assoc. 1999;99:S96-104. [PMID: 10450301]
11. Svetkey LP, Simons-Morton D, Vollmer WM, Appel LJ, Conlin PR, Ryan
DH, et al. Effects of dietary patterns on blood pressure: subgroup analysis of the
Dietary Approaches to Stop Hypertension (DASH) randomized clinical trial.
Arch Intern Med. 1999;159:285-93. [PMID: 9989541]
12. Neter JE, Stam BE, Kok FJ, Grobbee DE, Geleijnse JM. Influence of weight
reduction on blood pressure: a meta-analysis of randomized controlled trials.
Hypertension. 2003;42:878-84. [PMID: 12975389]
13. The effects of nonpharmacologic interventions on blood pressure of persons
with high normal levels. Results of the Trials of Hypertension Prevention, Phase
I. JAMA. 1992;267:1213-20. [PMID: 1586398]
14. Cutler JA. Randomized clinical trials of weight reduction in nonhypertensive
persons. Ann Epidemiol. 1991;1:363-70. [PMID: 1669517]
15. Kelley GA, Kelley KS. Progressive resistance exercise and resting blood pressure : A meta-analysis of randomized controlled trials. Hypertension. 2000;35:
838-43. [PMID: 10720604]
16. Whelton SP, Chin A, Xin X, He J. Effect of aerobic exercise on blood
pressure: a meta-analysis of randomized, controlled trials. Ann Intern Med. 2002;
136:493-503. [PMID: 11926784]
17. Xin X, He J, Frontini MG, Ogden LG, Motsamai OI, Whelton PK. Effects
of alcohol reduction on blood pressure: a meta-analysis of randomized controlled
trials. Hypertension. 2001;38:1112-7. [PMID: 11711507]
18. Kincaid J, Fishburne RP Jr, Rogers RL, Chissom BS. Derivation of new
readability formulas (Automated Readability Index, Fog Count, and Flesch Reading Ease Formula) for Navy enlisted personnel. Research Branch Report 8-75.
Millington, TN: Naval Technical Training U.S. Naval Air Station, Memphis;
1975.

www.annals.org

Article

19. Bosworth HB, Olsen MK, Neary A, Orr M, Grubber J, Svetkey L, et al.
Take Control of Your Blood Pressure (TCYB) study: a multifactorial tailored
behavioral and educational intervention for achieving blood pressure control.
Patient Educ Couns. 2008;70:338-47. [PMID: 18164894]
20. Bosworth HB, Bastian LA, Kuchibhatla MN, Steffens DC, McBride CM,
Skinner CS, et al. Depressive symptoms, menopausal status, and climacteric
symptoms in women at midlife. Psychosom Med. 2001;63:603-8. [PMID:
11485114]
21. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL
Jr; National Heart, Lung, and Blood Institute Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
The Seventh Report of the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA.
2003;289:2560-72. [PMID: 12748199]
22. Hedeker D, Gibbons RD. Longitudinal Data Analysis. New York: J Wiley;
2006.
23. Bosworth HB, Olsen MK, Goldstein MK, Orr M, Dudley T, McCant F,
et al. The veterans study to improve the control of hypertension (V-STITCH):
design and methodology. Contemp Clin Trials. 2005;26:155-68. [PMID:
15837438]
24. Bosworth HB, Olsen MK, Dudley T, Orr M, Goldstein MK, Datta SK,
et al. Patient education and provider decision support to control blood pressure
in primary care: a cluster randomized trial. Am Heart J. 2009;157:450-6.
[PMID: 19249414]
25. Fitzmaurice G, Laird NM, Ware JH. Applied Longitudinal Analysis. Hoboken, NJ: J Wiley; 2004. Wiley Series in Probability and Statistics.
26. SAS Knowledge Base. Samples & SAS Notes. Sample 24982: jackknife and
bootstrap analyses. Accessed at http://support.sas.com/kb/24/982.html on 18 August 2009.
27. Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by
home monitoring: meta-analysis of randomised trials. BMJ. 2004;329:145.
[PMID: 15194600]
28. Stahl SM, Kelley CR, Neill PJ, Grim CE, Mamlin J. Effects of home blood
pressure measurement on long-term BP control. Am J Public Health. 1984;74:
704-9. [PMID: 6742256]
29. Campbell NR, Bass M, Chockalingam A, LeBel M, Milkovich L. Selfmeasurement of blood pressure: benefits, risks and interpretation of readings. The
Canadian Coalition for High Blood Pressure Prevention and Control. Can J
Cardiol. 1995;11 Suppl H:18H-22H. [PMID: 7489539]
30. Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of
blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2006:
CD005182. [PMID: 17054244]
31. Boulware LE, Daumit GL, Frick KD, Minkovitz CS, Lawrence RS, Powe
NR. An evidence-based review of patient-centered behavioral interventions for
hypertension. Am J Prev Med. 2001;21:221-32. [PMID: 11567845]
32. Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management
education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004;164:1641-9.
[PMID: 15302634]
33. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of
a self-reported measure of medication adherence. Med Care. 1986;24:67-74.
[PMID: 3945130]

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Annals of Internal Medicine

Current Author Addresses: Drs. Bosworth and Powers and Ms. Neary:
Center for Health Services Research in Primary Care, Duke University,
2424 Erwin Road, Hock Plaza, Durham, NC 27703.
Drs. Olsen and Oddone, Ms. Grubber, and Ms. Orr: Durham Veterans
Affairs Medical Center (152), 508 Fulton Street, Durham, NC 27705.
Dr. Adams: Duke University Medical Center, Box 3230, Durham, NC
27710.
Dr. Svetkey: Duke Hypertension Center, Sarah W. Stedman Nutrition
and Metabolism Center, 3475 Erwin Road, Suite 100, Durham, NC
27705.
Drs. Reed and Dolor and Ms. Li: Duke Clinical Research Institute, 2400
Pratt Street, Room 311, Durham, NC 27705.
Author Contributions: Conception and design: H.B. Bosworth, M.K.

Olsen, M.M. Orr, M.B. Adams, L.P. Svetkey, E.Z. Oddone.

Analysis and interpretation of the data: H.B. Bosworth, M.K. Olsen,
J.M. Grubber, L.P. Svetkey, S.D. Reed, Y. Li, E.Z. Oddone.

W-224 17 November 2009 Annals of Internal Medicine Volume 151 Number 10

Drafting of the article: H.B. Bosworth, M.K. Olsen, J.M. Grubber, A.M.
Neary, M.M. Orr, E.Z. Oddone.
Critical revision of the article for important intellectual content: H.B.
Bosworth, M.K. Olsen, A.M. Neary, B.J. Powers, M.B. Adams, L.P.
Svetkey, S.D. Reed, R.J. Dolor, E.Z. Oddone.
Final approval of the article: H.B. Bosworth, M.K. Olsen, M.M. Orr,
L.P. Svetkey, S.D. Reed, Y. Li, R.J. Dolor, E.Z. Oddone.
Provision of study materials or patients: A.M. Neary, B.J. Powers, L.P.
Svetkey.
Statistical expertise: H.B. Bosworth, M.K. Olsen, J.M. Grubber, Y. Li.
Obtaining of funding: H.B. Bosworth, M.K. Olsen, E.Z. Oddone.
Administrative, technical, or logistic support: H.B. Bosworth, M.M.
Orr, M.B. Adams, R.J. Dolor, E.Z. Oddone.
Collection and assembly of data: J.M. Grubber, A.M. Neary, M.M. Orr,
Y. Li.

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