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Randomized Controlled Trial
. 2023 Nov;11(11):1521-1530.
doi: 10.1016/j.jchf.2023.05.033. Epub 2023 Jul 26.

Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure

Jessica R Golbus  1 , Kensey Gosch  2 , Mary C Birmingham  3 , Javed Butler  4 , Ildiko Lingvay  5 , David E Lanfear  6 , Antonio Abbate  7 , Mikhail L Kosiborod  2 , C V Damaraju  3 , James L Januzzi Jr  8 , John Spertus  2 , Brahmajee K Nallamothu  9
Affiliations
Free article
Randomized Controlled Trial

Association Between Wearable Device Measured Activity and Patient-Reported Outcomes for Heart Failure

Jessica R Golbus et al. JACC Heart Fail. 2023 Nov.
Free article

Abstract

Background: Wearable devices are increasingly used in research and clinical care though the relevance of their data in the context of validated outcomes remains unknown.

Objectives: The purpose of this study was to characterize the relationship between smartwatch activity and patient-centered outcomes in patients with heart failure.

Methods: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) was a randomized-controlled clinical trial that enrolled participants with heart failure and a compatible smartphone. Participants were provided a Fitbit Versa 2 and completed serial Kansas City Cardiomyopathy Questionnaires (KCCQs) through a smartphone application. We evaluated the relationship between daily step count and floors climbed and KCCQ total symptom (TS) and physical limitation (PL) scores at baseline and their respective changes between 2 and 12 weeks using linear regression models, with restricted cubic splines for nonlinear associations.

Results: In total, 425 patients were included: 44.5% women, 40.9% with reduced ejection fraction. Baseline daily step count increased across categories of KCCQ-TS scores (2,437.6 ± 1,419.5 steps/d for scores 0 to 24 vs 4,870.9 ± 3,171.3 steps/d for scores 75 to 100; P < 0.001) with similar results for KCCQ-PL scores. This relationship remained significant for KCCQ-TS and KCCQ-PL scores after multivariable adjustment. Importantly, changes in daily step count were significantly associated with nonlinear changes in KCCQ-TS (P = 0.004) and KCCQ-PL (P = 0.003) scores. Floors climbed was associated with baseline KCCQ scores alone.

Conclusions: Daily step count was nonlinearly associated with health status at baseline and over time in patients with heart failure. These results may inform interpretation of wearable device data in clinical and research contexts. (A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure [CHIEF-HF]; NCT04252287).

Keywords: heart failure; mobile technology; patient-reported outcomes; physical activity; wearable device.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Golbus has received funding from the National Institutes of Health (L30HL143700); and has received salary support by an American Heart Association grant (grant number 20SFRN35370008). Dr Birmingham is a former employee of Janssen Scientific Affairs, LLC. Dr Lingvay has received research funding (paid to institution) from Novo Nordisk, Sanofi, Merck, Pfizer, Mylan, and Boehringer-Ingelheim; and has received advisory/consulting fees and/or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, Johnson and Johnson, Intercept, Intarcia, TARGETPharma, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Zealand Pharma, Shionogi, Carmot Therapeutics, Structure Therapeutics, and Bayer. Dr Lanfear has been supported in part by the National Institute for Minority Health and Disparities (P50MD017351); has been a consultant for Abbott Laboratories, Amgen, AstraZeneca, Cytokinetics, Illumina, Janssen, Martin Pharmaceuticals, Vicardia, and DCRI (Novartis); and has participated in clinical research from Amgen, AstraZeneca, Bayer, Critical Diagnostics, Illumina, Lilly, Somalogic, and Janssen. Dr Abbate has received a consulting fee from Janssen. Dr Januzzi is a Trustee of the American College of Cardiology; is a board member of Imbria Pharmaceuticals; is a Director at Jana Care; has received grant support from Abbott, Applied Therapeutics, HeartFlow, Innolife, and Roche Diagnostics; has received consulting income from Abbott, Beckman, Bristol Myers Squibb, Boehringer Ingelheim, Janssen, Novartis, Pfizer, Merck, Roche Diagnostics, and Siemens; and has participated in clinical endpoint committees/data safety monitoring boards for Abbott, AbbVie, CVRx, Intercept, and Takeda. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Merck, Janssen, Bristol Myers Squibb, Edwards, Kineksia, 4DT Medical, Terumo, Cytokinetics, Imbria, and United Healthcare; holds research grants from Bristol Myers Squibb, Abbott Vascular, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. Dr Nallamothu is a principal investigator or coinvestigator on research grants from the National Institutes of Health, VA Health Services Research and Development Service, the American Heart Association, and Apple, Inc; has received compensation as Editor-in-Chief of Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association; and is a co-inventor on U.S. Utility Patent Number US15/356,012 (US20170148158A1) entitled “Automated Analysis of Vasculature in Coronary Angiograms” that uses software technology with signal processing and machine learning to automate the reading of coronary angiograms, held by the University of Michigan. The patent is licensed to AngioInsight, Inc, in which Dr Nallamothu holds ownership shares and receives consultancy fees. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

  • Step by Step: Really Need It in Our World.
    Psotka MA. Psotka MA. JACC Heart Fail. 2023 Nov;11(11):1531-1533. doi: 10.1016/j.jchf.2023.06.016. Epub 2023 Jul 26. JACC Heart Fail. 2023. PMID: 37498274 No abstract available.

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