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. 2023 Sep 14;6(1):173.
doi: 10.1038/s41746-023-00921-9.

A randomized trial of a mobile health intervention to augment cardiac rehabilitation

Jessica R Golbus  1   2 , Kashvi Gupta  3 , Rachel Stevens  4 , V Swetha E Jeganathan  4 , Evan Luff  4 , Jieru Shi  5 , Walter Dempsey  5 , Thomas Boyden  6 , Bhramar Mukherjee  7 , Sarah Kohnstamm  4 , Vlad Taralunga  8 , Vik Kheterpal  8 , Susan Murphy  9 , Predrag Klasnja  10 , Sachin Kheterpal  11 , Brahmajee K Nallamothu  4   12   13
Affiliations

A randomized trial of a mobile health intervention to augment cardiac rehabilitation

Jessica R Golbus et al. NPJ Digit Med. .

Abstract

Mobile health (mHealth) interventions may enhance positive health behaviors, but randomized trials evaluating their efficacy are uncommon. Our goal was to determine if a mHealth intervention augmented and extended benefits of center-based cardiac rehabilitation (CR) for physical activity levels at 6-months. We delivered a randomized clinical trial to low and moderate risk patients with a compatible smartphone enrolled in CR at two health systems. All participants received a compatible smartwatch and usual CR care. Intervention participants received a mHealth intervention that included a just-in-time-adaptive intervention (JITAI) as text messages. The primary outcome was change in remote 6-minute walk distance at 6-months stratified by device type. Here we report the results for 220 participants enrolled in the study (mean [SD]: age 59.6 [10.6] years; 67 [30.5%] women). For our primary outcome at 6 months, there is no significant difference in the change in 6 min walk distance across smartwatch types (Intervention versus control: +31.1 meters Apple Watch, -7.4 meters Fitbit; p = 0.28). Secondary outcomes show no difference in mean step counts between the first and final weeks of the study, but a change in 6 min walk distance at 3 months for Fitbit users. Amongst patients enrolled in center-based CR, a mHealth intervention did not improve 6-month outcomes but suggested differences at 3 months in some users.

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Conflict of interest statement

Dr. Golbus receives funding from the NIH (L30HL143700, 1K23HL168220-01) and receives salary support by an American Heart Association grant (grant number 20SFRN35370008). Dr. Nallamothu is a principal investigator or co-investigator on research grants from the NIH, VA HSR&D and the American Heart Association. He also receives compensation as Editor-in-Chief of Circulation: Cardiovascular Quality & Outcomes, a journal of the American Heart Association. Finally, he 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. Dr. Sachin Kheterpal is a principal investigator or co-investigator on research grants from the US NIH, Blue Cross Blue Shield of Michigan, the American Heart Association, Apple, Merck & Co, and Becton Dickinson & Company; and is a co-inventor on US patent number 62/791,257 entitled “Automated System To Medical Procedures”, which is held by the University of Michigan. Dr. Klasnja is a principal investigator or a co-investigator on research grants from NIH. Dr. Murphy is a principal investigator or a co-investigator on research grants from NIH. Dr. Vik Kheterpal is a Principal and employee of CareEvolution. Mr. Taralunga is a Software Architect employed by CareEvolution.

Figures

Fig. 1
Fig. 1. Consort diagram.
*One participant withdrew from the study at 200 days due to hip fracture and was unable to complete his 6-month 6 min walk though did provide final step count data. Thus completed step count and withdrawals add to 112 control participants.
Fig. 2
Fig. 2. 6-min walk distance at baseline, 3-months, and 6-months for intervention and control groups of the study by device type.
The upper and lower bounds of the box refer to the 25th and 75th percentiles, and the line intersection in the box refers to the median. The dots outside of whiskers refer to outlying 6-min walk distances.
Fig. 3
Fig. 3. Step Count at baseline, 3-months, and 6-months for intervention and control groups of the study by device type.
The upper and lower bounds of the box refer to the 25th and 75th percentiles, and the line intersection in the box refers to the median. The dots outside of whiskers refer to outlying step counts.
See this image and copyright information in PMC

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