Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge–Rehabilitation Gap: Protocol for a Randomized Controlled Trial
Authors: Zhang Chao , Soliman-Hamad Mohamed , Robijns Roxanne , Verberkmoes Niels , Verstappen Frank , IJsselsteijn Wijnand A 
Published: March 2020

Background
Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs.

Objective
In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).

Methods
Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point.

Results
The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow.

Conclusions
Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge–rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion.

Trial Registration
Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040

International Registered Report Identifier (IRRID)
PRR1-10.2196/16737