BACKGROUND/RATIONALE:
Despite the impact of hypertension and the availability of well-defined therapies and widely accepted target values for blood pressure (BP), interventions to improve BP control have had limited success.

OBJECTIVE(S):
The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. We received an 11 month extension to evaluate 3 key components of the study (sustainability of BP effects, qualitative evaluation of the intervention, evaluation of the supporting materials used to ensure literacy levels and cultural sensitivity.)

METHODS:
A 4-arm randomized trial with 18-month follow-up. Patents were selected from primary care clinics at the Durham VA Medical Center. Of the 1551 eligible patients, 591 individuals were randomized to either usual care or one of three telephone-based intervention groups. The intervention phone calls were triggered based on home BP values transmitted via telemonitoring devices. Patients were instructed to take their BP three times a week and transmit to study team. Behavioral management involved promoting health behaviors. Medication management involved adjustment of hypertension medications by a study physician and nurse based on hypertension treatment guidelines. The primary outcome was changes in BP control measured at six-month intervals over 18 months. For the sustainability extension of the study, in additional to collection of BP values, we will use qualitative analysis to examine the audio interviews.

FINDINGS/RESULTS:
We enrolled 591 participants and randomized 147 to usual care, 148 to behavioral intervention, 159 to a medication management intervention, and 147 to a combined behavioral medication management intervention. The average age was 61 years (SD=12); 49% were African American; 38% had limited health literacy. Baseline systolic and diastolic BP was 129/77. 503 (85%) completed the 18-month follow-up. Both the behavioral management and medication management alone showed significant improvement, 13.3% (95% CI: 2.0%, 24.5%) and 13.5% (95% CI: 2.4% 24.6%), respectively at 12 months All intervention groups improved in systolic BP at 12 months relative to usual care, but only the combined group was significant -4.3 mm Hg (95% -8.5 to -0.2). By 18 months, there were no statistically significant differences in either BP control or systolic BP for the intervention groups compared to usual care.

We enrolled 42 participants in the sustainability phase of the study. Primary themes suggest that awareness of BP values, understanding of diet, exercise, weight, smoking, education about hypertension and consistency of nurse calls influenced behavioral change.

IMPACT:
Each intervention group demonstrated improvements in BP control or systolic BP at 12 months, but the improvements were not sustained at 18 months. None of the intervention groups increased health care use and the cost of the interventions was approximately $1,200 per patient over 18 months. Further work is required to identify individuals who will likely most benefit from this more intensive model of behavioral and medication management interventions in non-clinical settings.

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External Links for this Project

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PUBLICATIONS:

None at this time.

DRA: Health Systems Science
DRE: Treatment - Observational
Keywords: Behavior (patient), Hypertension, Telemedicine
MeSH Terms: none