A Pilot Sensor-controlled Digital Gaming Intervention With Real-time Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart Failure
Phase: NA
Conditions: Heart Failure
Sponsor: University of Texas at Austin

Study Title: A Pilot Sensor-controlled Digital Gaming Intervention With Real-time 
Behavior Tracking to Motivate Self-management Behaviors in Older Adults With Heart 
Failure   
 
NCT03947983 
 
Document Date: 06/02/2021 
 
Document Title: Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background: 
There remains a great need for in-home, scalable and resource-conservative approaches to 
support and motivate older adults especially in heart failure self-management behaviors with the 
poorest adherence: weight monitoring and physical activity.8,9 One promising approach is the use 
of sensor-controlled10 digital games (SCDGs), which offer an accessible learning and habit-
forming medium that can make heart failure self-management more engaging and immersive 
while objectively measuring heart failure self-management behaviors. 
 
Objective 
To compare trends in the primary outcome of engagement in the heart failure self-management 
behavior of daily weight-monitoring and secondary outcomes of physical activity engagement, 
quality of life, functional status, heart failure self-management knowledge, self-efficacy, and 
heart failure hospitalization at baseline and weeks 6, 12, and 24, in a SCDG playing group 
(Intervention Group: IG) versus a control group (CG) that receives sensors and app tracking 
weight monitoring and activity only. 
 
Study Protocol: 
Study Design: Prospective feasibility randomized controlled trial (1:1) with 2 parallel groups 
(sensors alone or sensors plus SCDG app) 
 
Study Population and Recruitment 
Before COVID-19, we identified potential participants through chart review at a cardiac 
rehabilitation center as well as through referrals by clinical case managers at an inpatient cardiac 
floor in central Texas. Research staff provided information on the study to adults who were age 
55 years or older, English-speaking diagnosed with HF, and classified in the New York Heart 
Association’s HF classification II to III [32] during their inpatient stay or outpatient visit to the 
cardiac center. Other eligibility criteria included smartphone ownership as a proxy measure to 
indicate prior familiarity with smartphone usage, ability to independently walk without a walker 
or human assistance, and score of 4 or above on the Mini-cog [33] cognitive screen. Exclusion 
criteria included severe visual or tactile impairments (e.g., legal blindness or severe arthritis), 
which would adversely prevent the use of a smartphone, or end-stage renal failure or terminal 
illness (e.g., cancer), both of which adversely affect HF prognosis [34]. 
 
To continue the trial during the COVID19 pandemic, all in-person interactions were converted to 
remote interactions. We used a secure, HIPAA-compliant email system to continue receiving 
referrals from clinical case managers at the inpatient HF center. In addition, we contracted with 
the participant recruitment company Trialfacts [35] to recruit participants online from the states 
of Texas and Oklahoma. The eligibility criteria remained the same, but the formal screening 
process then requested a narrative description of HF history or confirmation from the potential 
participant’s healthcare provider to confirm the individual’s HF diagnosis. 
 
Intervention Procedures  
CONSORT guidelines [40] informed this parallel-group RCT and reporting of outcomes. The 
SCDG intervention group (IG) received sensors tracking weight-monitoring and physical activity 
and played the SCDG app on a mobile smartphone; the control group (CG) received sensors 
tracking weight-monitoring and physical activity only. Both IG and CG participants were given 

the Withings Go activity tracker [41], Body smart weight scale [42], and Health Mate app [43] to 
record, store, and transmit daily weight and physical activity data, but the CG did not receive the 
SCDG app. Also, whereas the IG received standardized HF education [6,38] embedded within 
the SCDG, the CG received the same information in written format. Thus, the difference 
between the IG and CG as receipt of the SCGD gaming elements. The SCDG app transmitted IG 
participants’ game playing and the Health Mate app transmitted all participants’ sensor data to 
the research team via cellular data service or home Wi-Fi. Before the COVID19 pandemic, an 
intervention nursing research assistant installed the apps on IG and CG participants’ smartphones 
and trained participants to use the sensor devices and apps at either the participants’ homes or a 
location of their convenience. During the COVID19 pandemic, in-person interactions were 
converted to remote interactions. Contactless delivery of study equipment, video-conferencing 
on smartphones, and printed pictorial and video instructions allowed remote support for 
installation, training, and troubleshooting of the devices and apps. The study team members’ 
experience with the devices and apps during in-person interactions with the older adults in their 
homes helped inform the training materials that were provided to the participants during the 
pandemic. Installation and training times by the research team member varied widely during the 
remote phase from 0 (participant self-installation) to 180 minutes as compared to 45 to 120 
minutes during in-person phase.  
 
Randomization  
Participants were assigned into CG and IG with a 1:1 randomization ratio, such that the 2 groups 
were equivalent in terms of gender. Randomization was done after informed consent and the 
baseline survey were obtained. The allocation sequence list for block randomization was 
generated by an independent researcher at the Sealed Envelope Ltd website [44] with random 
block sizes of 2 and 4 and concealed in sequentially numbered, opaque, sealed, stapled envelopes 
until the trial group was assigned. To ensure blinding during assessment of the outcomes, the 
research assistant who delivered the intervention to the 2 groups was different from the research 
assistant who collected the baseline and follow-up surveys from the 2 groups. The researcher 
who performed the data analysis was blinded to the participant groups. The participants were 
also blinded to the IG 
 
Ethical Considerations 
The University of Texas at Austin Institutional Review Board approved this study on July 30, 
2018 (number 2017-12-0042).