Objectives-Evaluating a randomized controlled trial involving a tailored behavioral intervention conducted to improve blood pressure control.Methods-Adults with hypertension from two outpatient primary care clinics were randomly allocated to receive a nurse-administered behavioral intervention or usual care. In this ongoing study, patients receive the tailored behavioral intervention bi-monthly for two years via telephone; the goal of the intervention is to promote medication adherence and improve hypertension-related health behaviors. Patient factors targeted in the tailored behavioral intervention include perceived risk of hypertension and knowledge, memory, medical and social support, patients' relationship with their health care provider, adverse effects of medication therapy, weight management, exercise, diet, stress, smoking, and alcohol use.Results-The sample randomized to the behavioral intervention consisted of 319 adults with hypertension (average age = 60.5 years; 47% African-American). A comparable sample of adults was assigned to usual care (n=317). We had a 96% retention rate for the overall sample for the first 6 months of the study (93% at 12 months). The average phone call has lasted 18 minutes (range 2 to 51 minutes). From baseline to six months, self-reported medication adherence increased by 9% in the behavioral group vs. 1% in the non-behavioral group.Conclusion-The intervention is easily implemented and is designed to enhance adherence with prescribed hypertension regimen. The study includes both general and patient-tailored information based upon need assessment. The study design ensures internal validity as well as the ability to generalize study findings to the clinic settings. Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Practice Implications-Despite knowledge of the risks and acceptable evidence, a large number of hypertensive adults still do not have their blood pressure under effective control. This study will be an important step in evaluating a tailored multibehavioral intervention focusing on improving blood pressure control. NIH Public Access

Background The Take Control of Your Blood Pressure trial evaluated the effect of a multicomponent telephonic behavioral lifestyle intervention, patient self-monitoring, and both interventions combined compared with usual care on reducing systolic blood pressure during 24 months. The combined intervention led to a significant reduction in systolic blood pressure compared with usual care alone. We examined direct and patient time costs associated with each intervention. Methods We conducted a prospective economic evaluation alongside a randomized controlled trial of 636 patients with hypertension participating in each study intervention. Medical costs were estimated using electronic data representing medical services delivered within the health system. Intervention-related costs were derived using information collected during the trial, administrative records, and published unit costs. Results During 24 months, patients incurred a mean of $6965 (SD, $22,054) in inpatient costs and $8676 (SD, $9368) in outpatient costs, with no significant differences among the intervention groups. With base-case assumptions, intervention costs were estimated at $90 (SD, $2) for home blood pressure monitoring, $345 (SD, $64) for the behavioral intervention ($31 per telephone encounter), and $416 (SD, $93) for the combined intervention. Patient time costs were estimated at $585 (SD, $487) for home monitoring, $55 (SD, $16) for the behavioral intervention, and $741 (SD, $529) for the combined intervention. Conclusions Our analysis demonstrated that the interventions are cost-additive to the health care system in the short term and that patients’ time costs are nontrivial.

BACKGROUND: Several trials have demonstrated the efficacy of nurse telephone case management for diabetes (DM) and hypertension (HTN) in academic or vertically integrated systems. Little is known about the real-world potency of these interventions. OBJECTIVE: To assess the effectiveness of nurse behavioral management of DM and HTN in community practices among patients with both diseases. DESIGN: The study was designed as a patient-level randomized controlled trial. PARTICIPANTS: Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practices. Subjects were required to have inadequately controlled DM (hemoglobin A1c [A1c]≥ 7.5 %) but could have well-controlled HTN. INTERVENTIONS: All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years, for a total of 12 calls. Intervention patients received tailored DM-and HTN-focused behavioral content; control patients received non-tailored, non-interactive information regarding health issues unrelated to DM and HTN (e.g., skin cancer prevention). MAIN OUTCOMES AND MEASURES: Systolic blood pressure (SBP) and A1c were co-primary outcomes, measured at 6, 12, and 24 months; 24 months was the primary time point. RESULTS: Three hundred seventy-seven subjects were enrolled; 193 were randomized to intervention, 184 to control. Subjects were 55 % female and 50 % white; the mean baseline A1c was 9.1 % (SD=1 %) and mean SBP was 142 mmHg (SD=20). Eighty-two percent of scheduled interviews were conducted; 69 % of intervention patients and 70 % of control patients reached the 24-month time point. Expressing model estimated differences as (intervention -control), at 24 months, intervention patients had similar A1c [diff=0.1 %, 95 % CI (−0.3, 0.5), p=0.51] and SBP [diff=−0.9 mmH g, 95% CI (−5.4, 3.5), p=0.68] values compared to control patients. Likewise, DBP (diff=0.4 mmHg, p=0.76), weight (diff=0.3 kg, p=0.80), and physical activity levels (diff=153 MET-min/week, p=0.41) were similar between control and intervention patients. Results were also similar at the 6-and 12-month time points. CONCLUSIONS: In nine community fee-for-service practices, telephonic nurse case management did not lead to improvement in A1c or SBP. Gains seen in telephonic behavioral self-management interventions in optimal settings may not translate to the wider range of primary care settings.

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Background Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension. Methods Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness. Results Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort’s mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending. Conclusions If effective, the TEACH-DM intervention’s telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.