Natalie M Jayaram1, Yevgeniy Khariton1, Harlan M Krumholz1, Sarwat I Chaudhry1, Jennifer Mattera1, Fengming Tang1, Jeph Herrin1, Beth Hodshon1, John A Spertus2. 1. From the Department of Pediatric Cardiology, Children's Mercy Hospitals and Clinics, Kansas City, MO (N.J.); Department of Cardiovascular Outcomes Research, Saint Luke's Mid America Heart Institute/UMKC, Kansas City, MO (Y.K., F.T., J.A.S.); Department of Cardiology and Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, CT (H.M.K., S.I.C., J.H., B.H.); Yale New Haven Hospital Center for Outcomes Research and Evaluation, CT (H.M.K., J.M., B.H.); Yale University School of Public Health, New Haven, CT (J.M.); and Health Research and Educational Trust, Chicago, IL (J.H.). 2. From the Department of Pediatric Cardiology, Children's Mercy Hospitals and Clinics, Kansas City, MO (N.J.); Department of Cardiovascular Outcomes Research, Saint Luke's Mid America Heart Institute/UMKC, Kansas City, MO (Y.K., F.T., J.A.S.); Department of Cardiology and Center for Outcomes Research and Evaluation, Yale University School of Medicine, New Haven, CT (H.M.K., S.I.C., J.H., B.H.); Yale New Haven Hospital Center for Outcomes Research and Evaluation, CT (H.M.K., J.M., B.H.); Yale University School of Public Health, New Haven, CT (J.M.); and Health Research and Educational Trust, Chicago, IL (J.H.). spertusj@umkc.edu.
Abstract
BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS:Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.
RCT Entities:
BACKGROUND: Although noninvasive telemonitoring in patients with heart failure does not reduce mortality or hospitalizations, less is known about its effect on health status. This study reports the results of a randomized clinical trial of telemonitoring on health status in patients with heart failure. METHODS AND RESULTS: Among 1521 patients with recent heart failure hospitalization randomized in the Tele-HF trial (Telemonitoring to Improve Heart Failure Outcomes), 756 received telephonic monitoring and 765 usual care. Disease-specific health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within 2 weeks of discharge and at 3 and 6 months. Repeated measures linear regression models were used to assess differences in KCCQ scores between patients assigned to telemonitoring and usual care over 6 months. The baseline characteristics of the 2 treatment arms were similar (mean age, 61 years; 43% female and 39% black). Over the 6-month follow-up period, there was a statistically significant, but clinically small, difference between the 2 groups in their KCCQ overall summary and subscale scores. The average KCCQ overall summary score for those receiving telemonitoring was 2.5 points (95% confidence interval, 0.38-4.67; P=0.02) higher than usual care, driven primarily by improvements in symptoms (3.5 points; 95% confidence interval, 1.18-5.82; P=0.003) and social function (3.1 points; 95% confidence interval, 0.30-6.00; P=0.03). CONCLUSIONS: Telemonitoring results in statistically significant, but clinically small, improvements in health status when compared with usual care. Given that the KCCQ was a secondary outcome, the benefits should be confirmed in future studies. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00303212.
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