A WeChat-Based Rehabilitation Platform for Children and Adolescents with Congenital Heart Disease to Promote Cardiac FITness (HeartFIT): Protocol for a Mixed-Methods Strategy from Evidence-Based Design to Pilot Study

Figures & data

Figure 1 Schematic overview of the study workflow.

Table 1 Overview of Clinically Studied Digital Health Tools

Digital Health Tools	Feature Highlights	Design & Development	Usability & Feasibility	Facilitators and Barriers to Digital Health Adoption
MinPuls.nu software tool and a personal home page (www.minpuls.nu/)^Citation20	● Health education. ● Sending tailored interactive text encouragement  weekly. ● Personal exercise-planning and monitoring tool. ● Performance feedback. ● Motivation/encouragement. ● Recognition for weekly achievements.	A private software deliverer is responsible for the portal and has developed the software tool in collaboration with the coordinating investigator and a group of stakeholders.	Usability:  Not reported. Feasibility:  75.3% (119/158) completed the final assessment; but in the intervention group, only 57% fulfilled the compliance criteria of using the tool for ≥ 2 consecutive weeks.	Facilitators:  ● Interventions using eHealth are low cost.  ● The use of an existing and widely used eHealth platform, Mobile Fitness A/S Copenhagen, Denmark.  ● The consideration of Behavior Change Techniques. Barriers:  ● Less than 57% of the participants used the app at any one point in time.  ● Lack of consideration regarding system security and data privacy.
Web-based platform CHEO (www.cheoactive.ca)^Citation21	● A unique log-in account ● Providing simple, low-cost activity ideas, suggestions and progressions for improving movement skills or physical fitness (counselling). ● Activities available to the child will be aligned with the child’s physical activity restrictions. ● Kinesiology support will be provided remotely using electronic resources if necessary.	The physical activity tool kit resources were developed collaboratively with patients, families and clinicians, confirming suitability for clinic use and high patient priority.	Usability:  Not reported. Feasibility:  Not reported.	Facilitators:  ● Low resource cost of providing the individualized physical activity interventions.  ● The innovative, personalized, and user-friendly nature of the online tool kit resource for patients and their families. Barriers:  Not reported.
Web-based e-Learning platform Einstein (https://einstein.costner.is)^Citation22	● Providing exercise training video clips and serving  as a virtual training partner. ● Electronic reporting and the possibility of tracking. ● Automated messages can be sent to the patients  to remind him/her of the execution and vice versa  the supervisor when a training progress is missing.	Not reported.	Usability:  Not reported. Feasibility:  87.1% (61/70) patients completed the follow-up. The mean weekly exercise adherence was 33%.	Facilitators:  ● The videos served as a virtual training partner and exercise was performed simultaneously while watching the video.  ● The digital solution could deliver and monitor the intervention effectively.  ● Automatically recorded adherence and reminding messages.  ● eHealth provides easy and wide reachability by low cost. Barriers:  ● The standardized training protocol was not individual enough.  ● Insufficient exercise intensity.  ● Requiring more guidance or external supervision.  ● The flexible approach might have led to laziness and carelessness.  ● Time competition with existing leisure activities.
“Smart Heart” web-based app^Citation23	● Activity and nutrition behaviors tracking/ Self-  monitoring. ● Goal setting. ● Nutrition and physical activity resources. ● Facilitating communication between participants  and their health coaches.	Not reported.	Usability:  Not reported. Feasibility:  This study had a high retention rate (100%), a low attrition rate (2%); but majority of respondents did not find the web-based app to be a useful tool (54%) and a large proportion did not use it at all (28%).	Facilitators:  ● The use of smart phones in the study enabled to effectively   engage with the participants.  ● Cost-effective. Barriers:  ● The development of the online software required significantly   more time than was originally planned.  ● Web application needs improvement.  ● The web application was poorly implemented.  ● The web app lacks of personalization.

Table 2 Schedule of Enrolment, Interventions, and Assessments*

	STUDY PERIOD
	Enrolment	Allocation	Post-Allocation	Close-Out
TIMEPOINT	Day −14 to 0	Day 0 (1st Visit)	Week 1 to 12 (Intervention)	Week 13 (2nd Visit)
ENROLMENT:
Eligibility screen step 1^†	x
Eligibility screen step 2^‡	x
Informed consent	x
Allocation		x
INTERVENTIONS:
HeartFIT intervention			←―→
Usual care			←―→
ASSESSMENTS:
Demographics and clinical characteristics		x
Primary outcome: CPET		x		x
Secondary outcomes: ActiGraph wGT3X-BT, Hand Dynamometer, InBody 770, PAQ-C/PAQ-A, PedsQL^TM, CSAPPA, RCADS, ACTS-MG		x		x
Study feasibility: recruitment, retention, adherence and data collection			x
Treatment acceptability and satisfaction				x
Adverse event reporting			←―→

Notes: *Recommended content displayed using schematic format as suggested by SPIRIT 2013.⁴⁰ The symbol “x” indicates a timepoint and the symbol “←―→” indicates a time period. ^†The first round of eligibility screen for demographics and clinical characteristics. ^‡The second round of eligibility screen for peak exercise capacity.

Abbreviations: CPET, cardiopulmonary exercise test; PAQ-C/PAQ-A, the physical activity questionnaire for older children and adolescents; PedsQL^TM, Pediatric Quality of Life Inventory^TM; CSAPPA, the children’s self-perceptions of adequacy in and predilection for physical activity; RCADS, the revised child anxiety and depression scale; ACTS-MG, the activity support scale for multiple groups.

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