Atrial fibrillation
Conditions
Interventions
 
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 Samsung Galaxy Watch Active 2 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 able to report their lifestyle data via a chatbot 
integrated in the lifestyle monitoring system. The use of the chatbot is optional. 
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 
Sponsors
Máxima MC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with recurrent atrial fibrillation (newly diagnosed or existing), classified as at least EHRA class IIb. - Age >= 18 years. - Able to speak and read the Dutch language. - Willing and able to provide informed consent.
Exclusion criteria
Exclusion criteria: - No internet connection at home. - Not in possession of a computer or tablet; and mobile phone. - Not able or willing to wear activity tracker on a daily basis (for example due to work related obligations). - Major planned (cardiac) surgery in the upcoming 3 months. - Life expectancy < 1 year (e.g., severe renal disease, metastatic cancer). - Physical impairments interfering with the lifestyle monitoring system, including not able to perform daily physical activities due to orthopedic or neurological disease, bed/chair ridden patients, visual impairments/blindness, sever cognitive disability. - Presence of wounds, injuries or infectious diseases on the skin where the wrist-wearable device(s) will be placed. - Other contra-indications for wearing the smartwatch (people with pacemakers, or implantable cardioverter defibrillators). - Individuals deemed not mentally able to use the app.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is sufficient adherence, defined as >75% of adherence. Adherence is defined as the proportion of time the gamified mobile application was opened during the 3-month gamification intervention integrated with a recently developed platform for continuous lifestyle monitoring (Care-On) in patients with recurrent atrial fibrillation (newly diagnosed or existing), classified as at least EHRA class IIb. Adherence=(Number of days the app was opened / Total intervention days (84)) x 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1) Lifestyle behavior change after 3 and 6 months (physical activity, sedentary behavior, smoking, alcohol consumption, nutrition behavior and mental stress) assessed by the percentage change from the baseline to the 3-month and 6-month mark post the baseline assessment. The correlation between adherence to the intervention and lifestyle behaviors will be compared for each of the lifestyle factors separately 2) AF symptoms assessed by the Atrial Fibrillation Severity Scale (AFSS) 3) Quality of life, the difference in quality-of-life assessments from baseline to the 3-month and 6-month time points after the start of the intervention aiming to capture any improvements attributed to adherence to the intervention 4) Usability will be measured using the System Usability Scale (SUS) score. 5) To measure the correlation of the self efficacy with adherence, the General Self*Efficacy Scale (GSES) will be used | — |
Countries
Netherlands
Contacts
Public ContactA Mantziari Zafeiri
Technische Universiteit Eindhoven
Outcome results
None listed