JMIR Publications

ABSTRACT

Background:

Home-based cardiac rehabilitations (CR) 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 intervention and formal CR programs. In the Netherlands and some other countries (e.g., Australia), patients after cardiac interventions stay at home for 3-4 weeks without any support from physicians, and often engage in very little physical activity because of a lack of self-efficacy. A simple home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, and potentially increase the uptake rate for those programs.

Objective:

In a randomized controlled trial, we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition) by 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 perform better on a bicycle ergometer test (secondary outcome). We will also explore which specific features of the mobile coaching app actively contribute to the effectiveness of the technology.

Methods:

Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the two parallel groups. Eligible patients are those who are scheduled in the post-anesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without serious medical conditions that may increase risks associated with doing physical exercise. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 4-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 compliance with the program in the first three week will be measured by the Axivity AX3 accelerometer worn as a wristband. Patients in the treatment group will also be supported by the Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their clinicians. In the fourth week after discharge, all patients will perform a bicycle ergometer test and for returning the devices. Additionally, 5 questionnaires are sent to the patients by e-mail at the discharge and at the end of each study week to assess their psychological states regarding physical activities (e.g., attitude, self-efficacy). To minimize bias, the randomization procedure will be done after the introduction of the exercise program so that the nurse practitioners are blind to the experimental condition 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 study population is indeed feasible. We expect to complete the randomized controlled trial by the end of 2020, and statistical analyses will follow.

Conclusions:

The results 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 results are positive, lessons drawn from the study will also inform the translation of the technology-enhanced program to clinical practice. Clinical Trial: Registered at Netherlands Trial Register, ID: NL8040; https://www.trialregister.nl/trial/8040b