Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias
Phase: NA
Conditions: Sedentary Lifestyle, Stress, Psychological
Sponsor: Brandeis University

 
 
 
 
 
 
Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or 
Related Dementias 
 
NCT03124550 
 
 
Study Protocol and Statistical Analysis Plan 
 
Upload Date: 09/07/2020 
Document Date: 09/20/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
We conducted a 6-week mixed-methods study to evaluate caregivers’ user experiences with 
Go&Grow and its impact on their well-being. Prior to recruitment, this study was approved by 
our institutional review board. 
Procedure & Data Collection  
Session 1  
In the first meeting, participants completed the consent form, demographic survey, and a 
pretest survey. Participants then received the Fitbit Alta HR, a Fitbit training, and a paper guide 
on how to use the Fitbit. Participants were asked to wear the Fitbit for the following week to 
assess their baseline physical activity level.  
 
Session 2 & Deployment Period  
After one week of using the Fitbit, participants were trained on how to use Go&Grow. 
Caregivers were then asked to wear the Fitbit and use Go&Grow at least once every other day 
for 6 weeks. Automated system logs collected data regarding participants’ use of Go&Grow, 
such as when users logged into Go&Grow, when a story was posted, viewed, liked, or replied. 
Participants were compensated with a $5 Amazon gift card for completing the weekly survey 
each week. 
Session 3  
After six weeks of using Go&Grow, we conducted semi-structured interviews using the 
Data-Driven Retrospective Interviewing method. Before the Session 3 interview, we reviewed 
each caregiver’s log data (e.g., number of days logging onto Go&Grow, and number of stories 
posted) to begin assessing their Go&Grow engagement; we probed identified data patterns in the 
interview to examine how and why participants used Go&Grow, game enjoyment, physical 
activity, motivation, and social connectedness. Finally, participants completed a posttest survey 
that was the same as the pretest given at baseline. 
 
Analysis  
Paired T-tests were conducted to examine whether caregivers’ exercise self-efficacy and 
their management of distress scores changed significantly at posttest compared to the pretest. 
Within-person (WP) relationships between time (week), steps, and social contact were 
tested. Multilevel modeling with the LMER package in R was used to determine whether 
participants increased in weekly average steps and weekly social contact over the 6-week 
intervention. We used the following model:  
 
Level 1: Outcome ij = ß0j + ß 1(week) ij + e ij  
Level 2: ß0j = γ00 + u0j  
 
Weekly steps at level 1 were expressed as a wp intercept, week & wp error term. For 
level 2, wp intercept was expressed as a function of fixed intercept.