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Vol 122, No 21

November 23, 2010

Advisory Board; Significant; Sanofi Aventis, Boehringer Ingelheim. L.M. Monk RN, MSN: None. M.L. Roettig RN, MSN: None. H.R. Al-Khalidi PhD: None. R.J. Applegate MD: None. C.C. Corbett MMS, NREMT-P: None. J.L. Garvey MD: None. W.R. Hathawy MD: None. B.H. Wilson MD: None. J.G. Jollis MD: Research Grant; Modest; Sanofi-aventis, Medtronic, Phillips.

Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a Randomized, Controlled Intervention Trial Investigating the Impact of Telemedicine on Mortality in Ambulatory Patients With Chronic Heart Failure


21787 Comparative Effectiveness of Two Telephone-Delivered Behavioral Interventions to Improve Hypertension Control. Primary Outcomes of a Randomized Controlled Trial

Sundar Natarajan, Jennifer Friedberg, Michelle Ulmer, Iris Lin, Donald Robinaugh, VA New York Harbor Healthcare System, New York, NY; John Allegrante, Teachers College, Columbia Univ, New York, NY; Judith Wylie-Rosett, Albert Einstein College of Medicine, Bronx, NY; Stuart R Lipsitz; Brigham and Womens Hosp, Boston, MA

Introduction: The effectiveness of blood pressure (BP) control (systolic BP [SBP] 130 mm Hg and diastolic BP [DBP] 80 mm Hg in diabetes or kidney disease, or SBP 140 mm Hg and DBP 90 mm Hg in all others) in preventing cardiovascular events is proven. Despite this, a large gap exists between ideal control rates and what is achieved in clinical practice. Although several behavioral trials to improve BP have been reported, the BP control achieved was modest. Few, however, used novel telehealth approaches to target patients with uncontrolled BP in primary care settings. Methods: Using a 3-arm, randomized controlled trial, we evaluated the effect of a stage-matched intervention (SMI) or a health education intervention (HEI) to improve BP control in adults with uncontrolled BP despite treatment with antihypertensive drugs for 6 months; usual care (UC) served as control. The SMI and HEI groups received monthly phone counseling targeting diet, exercise and BP medication adherence for 6 months; the SMI used the Transtheoretical Model to tailor counseling while HEI received nontailored education using national guidelines. All participants made study visits at baseline, 3, and 6 months. BP, the primary outcome, was assessed from the mean of 6 readings and categorized as controlled or not. Comparisons between groups were by 2 tests. Results: We recruited and randomized 533 participants with sustained uncontrolled BP from 2 large hospital-based outpatient clinics. There were no differences between groups at baseline. The baseline BP control rates were 42.6%, 40.6%, and 44.6% in SMI, HEI, and UC (p.74). The 6 month BP control rates were 62.3% (SMI), 52.4% (HEI), and 47.2% (UC) with p values for pairwise comparisons being .016 (SMI vs. UC), .280 (HEI vs. UC), and .066 (SMI vs. HEI). Further, the change in BP control from baseline to 6 months by arm were 19.5% (SMI), 11.9% (HEI) and 0.6 % (UC) with p values for the null hypothesis of change 0 within each arm being 0.00003 (SMI), 0.012 (HEI) and 0.887 (UC). Conclusions: SMI improved BP control compared to UC. Both SMI and HEI improved BP control compared to their own baseline. SMI constitutes a new, more potent and potentially cost-effective approach to assisting patients with sustained uncontrolled hypertension reach BP control goals.

Author Disclosures: S. Natarajan: None. J. Friedberg: None. M. Ulmer: None. I. Lin: None. D. Robinaugh: None. J. Allegrante: None. J. Wylie-Rosett: None. S.R. Lipsitz: None.

Friedrich Köhler, Sebastian Winkler, Charite´ CCM, Dept of Cardiology, Berlin, Germany; Michael Schieber, Udo Sechtem, Robert-Bosch-Krankenhaus Stuttgart, Dept of Cardiology, Stuttgart, Germany; Karl Stangl, Charite´ CCM, Dept of Cardiology, Berlin, Germany; Michael Böhm, Univ Hosp Saarland, Dept of Cardiology, Homburg / Saar, Germany; Herbert Boll, Robert-Bosch GmbH, Stuttgart, Germany; Götz Gelbrich, Universit¨at Leipzig, KKS, Leipzig, Germany; Bridget-Ann Kirwan, SOCAR Rsch SA, Nyon, Switzerland; Stefan D Anker; Charite´ CVK, Dept of Cardiology, Berlin, Germany

Rationale: Remote patient management (telemedicine) may help to detect early signs of cardiac decompensation, allow to optimize therapy and improve treatment compliance in chronic heart failure (CHF). Two meta-analyses suggested that telemedicine in CHF can reduce mortality by 30–35%. We aimed to prospectively investigate the impact of telemedical management on mortality in ambulatory CHF patients. DESIGN: CHF patients (NYHA II/III, LVEF35%) with a history of cardiac decompensation with hospitalization in the past 18 months (no hospitalization required if LVEF25%), were randomized 1:1 to an intervention group of daily remote device monitoring (ECG, blood pressure, body weight) coupled with medical telephone support or to usual care lead by the patients’ local physician. In the intervention group 24/7 physician led medical support was provided by 2 central telemedical centers (located in Berlin and Stuttgart). Methods: We recruited ambulatory patients in 3 areas of varying economic status in Germany (Berlin, Brandenburg and Baden-W ¨urttemberg). A clinical event committee blinded to treatment allocation assessed cause of death and reason for hospitalization. Primary endpoint: total mortality; first secondary endpoint: composite of cardiovascular mortality or hospitalization due to heart failure; other secondary endpoints included cardiovascular mortality, all-cause and cause-specific hospitalizations (all time to first event) as well as days lost due to heart failure hospitalization or cardiovascular death (in % of follow-up time), and quality of life and NYHA class at 12 months. Results: Overall, 710 CHF patients were recruited. The follow-up was at least 12 months in all patients (mean 24.35.1 months) and overall amounted to 1437 patient-years. Survival information will be available for all patients. Baseline details of all patients: age 6711 yrs, female gender 19%, LVEF 276%, NYHA class III 50%, ACEi/ARB treatment 95%, beta-blocker treatment 92%, diuretics 92%, ICD therapy 48%. Conclusion: This study will provide information on the efficacy of telemedical 24/7 physician led support in CHF patients with systolic dysfunction over a mean follow-up of 24 months. Results of TIM-HF will be available by September 2010 and will be presented.

Author Disclosures: F. Köhler: None. S. Winkler: None. M. Schieber: None. U. Sechtem: None. K. Stangl: None. M. Böhm: None. H. Boll: Employment; Significant; BOSCH AG. G. Gelbrich: None. B. Kirwan: SOCAR Research SA. S.D. Anker: Consultant/Advisory Board; Significant; BOSCH AG.

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