@article{7bbef3952f784ec98b2bb5fbe82b9c3a,
title = "A Randomized Controlled Trial of Mobile Health Intervention in Patients With Heart Failure and Diabetes",
abstract = "Background: Mobile health (mHealth) platforms can affect health behaviors but have not been rigorously tested in randomized trials. Objectives: We sought to evaluate the effectiveness of a pragmatic mHealth intervention in patients with heart failure (HF) and diabetes (DM). Methods: We conducted a multicenter randomized trial in 187 patients with both HF and DM to assess an mHealth intervention to improve physical activity and medication adherence compared to usual care. The primary endpoint was change in mean daily step count from baseline through 3 months. Other outcomes included medication adherence, health-related quality of life and metabolomic profiling. Results: The mHealth group had an increase in daily step count of 151 steps/day at 3 months, whereas the usual-care group had a decline of 162 steps/day (least squares mean between-group difference = 313 steps/day; 95% CI: 8 619; P = 0.044). Medication adherence, measured using the Voils Adherence Questionnaire, did not change from baseline to 3 months (LS-mean change –0.08 in mHealth vs –0.15 in usual care; P = 0.47). The mHealth group had an improvement in Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared to the usual-care group (LS-mean difference = 5.5 points, 95% CI: 1.4, 9.6; P = 0.009). Thirteen metabolites, primarily medium- and long-chain acylcarnitines, changed differently between treatment groups from baseline to 3 months (P < 0.05). Conclusions: In patients with HF and DM, a 3-month mHealth intervention significantly improved daily physical activity, health-related quality of life and metabolomic markers of cardiovascular health but not medication adherence. Condensed Abstract: Heart failure (HF) and diabetes (DM) have overlapping biological and behavioral risk factors. We conducted a multicenter randomized, clinical trial in 187 patients with both HF (regardless of ejection fraction) and DM to assess whether an mHealth intervention could improve physical activity and medication adherence. The mHealth group had an increase in mean daily step count and quality of life but not in medication adherence. Medium- and long-chain acylcarnitines changed differently in treatment groups from baseline to 3 months (P < 0.05). These data have important implications for designing effective lifestyle interventions in HF and DM.",
keywords = "Heart failure, diabetes, mobile health",
author = "FELKER, {G. MICHAEL} and ABHINAV SHARMA and MENTZ, {ROBERT J.} and LILIN SHE and GREEN, {CYNTHIA L.} and GRANGER, {BRADI B.} and HEITNER, {JOHN F.} and LAUREN COOPER and TEUTEBERG, {J. E.F.F.} and GRODIN, {JUSTIN L.} and KENNETH ROSENFIELD and HUDSON, {L. O.R.I.} and KWEE, {LYDIA COULTER} and ILKAYEVA, {O. L.G.A.} and SHAH, {SVATI H.}",
note = "Funding Information: Dr. Felker reports research grants from NHLBI, American Heart Association, Amgen, Bayer, Merck, Cytokinetics, Myokardia; he has acted as a consultant to Novartis, Amgen, BMS, Cytokinetics, Medtronic, Cardionomic Boehringer-Ingelheim, American Regent, Abbott, Astra-Zeneca, Reprieve, and Sequana, and has served on clinical endpoint committees/data safety monitoring boards for Amgen, Merck, Medtronic, EBR Systems, V-Wave, LivaNova, Siemens, and Rocket Pharma. Dr Sharma reports receiving support from the Canadian Institute of Health Research (Grant # 175095), LEAP-Pecaut Centre, Fonds de Recherche Sant{\'e} Quebec (FRSQ) Junior 1 clinician scholars program, Alberta Innovates Health Solution, European Society of Cardiology young investigator grant, Roche Diagnostics, Boeringer-Ingelheim, Novartis, and Takeda. Dr. Mentz reports research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. Dr. Granger research support from Alpha Phi Foundation, American College of Preventive Medicine, American Heart Association, Center for Disease Control, NIH and Novartis. Dr Cooper reports research support from NHLBI and consulting for Astra Zeneca. Dr. Teuteberg reports consulting from Abbott, Abiomed, Medtronic, CardDx, Paragonix, and Takeda. Dr. Grodin reports research support from the Texas Health Resources Clinical Scholarship, Eidos/BridgeBio, and Salubris; he has acted as a consultant to Pfizer, Alnylam, Eidos/BridgeBio, and Sarepta. Dr. Rosenfeld reports research support to institution from NIH, Boston Scientific, Philips; Consultant/Scientific Advisory to Angiodynamics, Boston Scientific, Contego, Mayo Clinic, Neptune Medical, Philips, Surmodics, Thrombolex, Terumo, Truvic. Equity (stock options) in Accolade, Access Vascular, Althea, Contego, Embolitech, Endospan, InspireMD, Janacare, Magneto, Neptune, Orchestra, Shockwave, Thrombolex, Truvic, Valcare. Board member on National PERT Consortium. Dr. Shah is named as a co-inventor on an unlicensed patent held by Duke University. Funding Information: The TARGET-HF-DM study is funded by the American Heart Association Strategically Focused Research Network in Heart Failure (AHA-16SFRN30180010). Funding Information: The TARGET-HF-DM study is funded by the American Heart Association Strategically Focused Research Network in Heart Failure (AHA-16SFRN30180010). Dr. Felker reports research grants from NHLBI, American Heart Association, Amgen, Bayer, Merck, Cytokinetics, Myokardia; he has acted as a consultant to Novartis, Amgen, BMS, Cytokinetics, Medtronic, Cardionomic Boehringer-Ingelheim, American Regent, Abbott, Astra-Zeneca, Reprieve, and Sequana, and has served on clinical endpoint committees/data safety monitoring boards for Amgen, Merck, Medtronic, EBR Systems, V-Wave, LivaNova, Siemens, and Rocket Pharma. Dr Sharma reports receiving support from the Canadian Institute of Health Research (Grant # 175095), LEAP-Pecaut Centre, Fonds de Recherche Sant{\'e} Quebec (FRSQ) Junior 1 clinician scholars program, Alberta Innovates Health Solution, European Society of Cardiology young investigator grant, Roche Diagnostics, Boeringer-Ingelheim, Novartis, and Takeda. Dr. Mentz reports research support and honoraria from Abbott, American Regent, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim/Eli Lilly, Boston Scientific, Cytokinetics, Fast BioMedical, Gilead, Innolife, Medtronic, Merck, Novartis, Relypsa, Respicardia, Roche, Sanofi, Vifor, Windtree Therapeutics, and Zoll. Dr. Granger research support from Alpha Phi Foundation, American College of Preventive Medicine, American Heart Association, Center for Disease Control, NIH and Novartis. Dr Cooper reports research support from NHLBI and consulting for Astra Zeneca. Dr. Teuteberg reports consulting from Abbott, Abiomed, Medtronic, CardDx, Paragonix, and Takeda. Dr. Grodin reports research support from the Texas Health Resources Clinical Scholarship, Eidos/BridgeBio, and Salubris; he has acted as a consultant to Pfizer, Alnylam, Eidos/BridgeBio, and Sarepta. Dr. Rosenfeld reports research support to institution from NIH, Boston Scientific, Philips; Consultant/Scientific Advisory to Angiodynamics, Boston Scientific, Contego, Mayo Clinic, Neptune Medical, Philips, Surmodics, Thrombolex, Terumo, Truvic. Equity (stock options) in Accolade, Access Vascular, Althea, Contego, Embolitech, Endospan, InspireMD, Janacare, Magneto, Neptune, Orchestra, Shockwave, Thrombolex, Truvic, Valcare. Board member on National PERT Consortium. Dr. Shah is named as a co-inventor on an unlicensed patent held by Duke University. Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",
year = "2022",
month = nov,
doi = "10.1016/j.cardfail.2022.07.048",
language = "English (US)",
volume = "28",
pages = "1575--1583",
journal = "Journal of Cardiac Failure",
issn = "1071-9164",
publisher = "Churchill Livingstone",
number = "11",
}