Evaluation of the Feasibility of a Gamified Lifestyle Change Intervention for Patients with Atrial Fibrillation Scheduled for Catheter Ablation: GAMES4CARE.

Lifestyle behaviors including physical activity, nutrition, sleep, smoking and
management of mental stress are significant factors for the clinical course and
overall treatment results of chronic cardiac diseases. Specifically, it has
been shown that these lifestyle factors are strongly related to the disease
burden and quality of life of patients with atrial fibrillation (AF). Moreover,
cardiac rehabilitation was shown to improve lifestyle behavior and reduce
arrhythmia recurrence. Despite this evidence structured lifestyle interventions
and Cardiac Rehabilitation often fail to be implemented efficiently. The
reasons behind that can be patient-related (i.e., transportation problems,
working obligations, not appealing for specific subgroups) or/and
healthcare-related (i.e. low referral rates, limited facilities, and
resources).

Obviously, there is a need for personalized lifestyle interventions for these
patients which can be implemented easily, while avoiding burdening the
healthcare system. The proposed solution in this study is a structured
lifestyle intervention platform that will combine the holistic gamified
lifestyle interventions of the Greenhabit app integrated with a recently
developed continuous lifestyle monitoring system Care-On (digital platform with
wearable sensor and dashboard) that was evaluated in a recent study on
feasibility and adherence. Advantages of this novel intervention over
traditional cardiac rehabilitation from a patient perspective are that it does
not require hospital visits and that it may be more appealing than a
traditional program as it is a personalized goal-driven gamified intervention
and it can be done together with family or friends. From a hospital
perspective, the proposed intervention requires lower resources and personnel
deployment as it is a self-management intervention.

The hypothesis of this study is that a gamified lifestyle intervention,
integrated with a continuous lifestyle monitoring platform, will result in high
adherence rates over a 3-month period in patients with atrial fibrillation
referred for catheter ablation. We aim to evaluate the practicality of
implementing this intervention and its acceptance by the patients.

The primary objective of this study is to evaluate the adherence to a 3-month
gamification intervention integrated with a recently developed platform for
continuous lifestyle monitoring (Care-On) in patients with AF referred for
catheter ablation.


The secondary objectives are:

- To explore the relationship between adherence to the intervention and
improvements in lifestyle behaviors (physical activity, sedentary behavior,
smoking, alcohol consumption, nutritional behavior, and mental stress) at 3-
and 6-months post-baseline

- To evaluate the AF symptom burden

- To evaluate the usability of the intervention

- To explore potential improvements in patients* quality of life as a result of
the intervention

- To evaluate self-efficacy as a predictor of adherence to the gamified
lifestyle intervention

This is a single-centre, prospective interventional study

The intervention consists of the Greenhabit application which is integrated
with a recently developed lifestyle monitoring system that provide objective
feedback on lifestyle change (CARE-ON). Greenhabit (GH) works on physical and
mental health in small steps. It uses various behavior change models to help
people make healthy choices and develop new habits. Also, it uses gamification,
so the process to be more enjoyable.

Greenhabit consists of a 12-week journey, during which participants can open a
treasure chest which contains messages, challenges or measurements on a daily
basis. One of the daily measurements is the reflection of how their day was,
and it consists of five elements (Exercise, Healthy diet, social environment,
positive thinking, relaxation)

Patients will be instructed to wear the CardiacSense Watch 3 (CS3) as much as
possible (at least 12 hours per day) from the moment that they will have access
to the lifestyle monitoring system for a 3- month period. During this period
the patient will also be asked to report their lifestyle data via a chatbot
integrated in the lifestyle monitoring system with a max of a week per month of
reporting. The amount of lifestyle data reporting will depend on the two main
goals that they will select in the Greenhabit app.

The patient will have to interact daily with the Greenhabit (GH) app. The first
step is the selection of two main goals. On a daily basis, participants can
open a treasure chest which contains messages, challenges or measurements.
After a treasure chest is opened, the patient has specific days to read the
information, complete the challenge or the measurements.

There is a *travel journal* where the patient can reread what has learned.GH
also provides a feature in which a patient can choose a *buddy* (friend, sister
or partner) who is also following the programme with their own goals. Finally,
there is an App community, and the patient can share photos of their adventure
with people they have chosen.

The GH programme always starts on a Monday. The first Monday on the timeline
some questions appear and they are the baseline measurement. The patient*s
answers help the algorithm to personalize the information and challenges. These
questions which are based on different validated questionnaires, are repeated
every 28 days.
In the beginning, the patient needs to select two main goals that wants to work
towards. In total GH is providing 11 goals to choose from:

1) To be meaningful
2) Recovery or rehabilitation
3) More relaxed
4) Healthier eating
5) More energy
6) More balance
7) Social contacts
8) More moving
9) Weight loss
10) Being more positive
11) More self-confidence


During the game, GH is providing micro-goals which lead to the main goals. The
patient can choose their micro goals every Monday.

Based on the selection of the main goals at the GH the Chatbot of the lifestyle
monitoring system will ask the patients to report their lifestyle data.

The lifestyle intervention is not associated with significant risks as it
consists of general lifestyle advices supplemented with an exercise program
consisting of low to moderate intensity aerobic and strength exercises.
Exercises will be adjusted for patients with a low exercise capacity.

Participation in the intervention may be experienced as burdensome as patients
will be asked to wear an activity tracker (at least 12 hours per day)
throughout the 12-week period: this may be perceived as unpleasant and the
watch may cause irritation to the skin of the wrist when worn for long periods
of time. However, this is no more likely than wearing any other watch.
Furthermore, data on nutritional intake, mental stress and sleep quality will
be acquired via questionnaires and a chatbot connected to a patient monitoring
system accessible via mobile phone, tablet and desktop. Nevertheless, patients
participate on a voluntary basis and will be motivated to improve their
lifestyle behaviour. The number of hospital visits required for the
intervention (i.e. 3 times, at baseline, 3 months and 6 months) is
substantially lower than in the regular cardiac rehabilitation program.

The wrist-worn device (CS3) has been tested and found to be biocompatible.
There are no known adverse events related to the use of CS System 3; however,
there are possible adverse events related to monitoring systems that involve
sensor application on the skin. These include the following:
i) Edema, ii), Erythema, iii) Irritation, iv) Sensitization