Aim 1 Procedures:
After the patient has signed consent with the study coordinator, the coordinator will
schedule the patient for their baseline in-person visit. They will also let Co-PI
Ayyaswami and Co-I Subramanian know via Epic the patient consented to the study. At this
point, one of the two clinician investigators will order the Mychart Fitness Tracker
flowsheet through the EHR.
During the baseline visit, the study team will conduct standard height and weight
assessments. They will also conduct a waist circumference assessment, consisting of two
measurements (taking the average of the two). There will be an optional body composition
analysis will take place in the Weight Center (UMass Memorial main hospital). The
assessment will be done on a seca mBCA 554. The analysis takes 1-2 minutes, and involves
the patient standing on a scale/platform and holding onto the hand railings. The analysis
will be conducted by a member a member of the study team, who will be trained in using
the scale. The scale will then print out the results of the patients body composition (%
lean body mass, % water, % body fat, including areas of distribution). This readout of
data will be retained by the study team and entered into REDCap, along with scanned into
the patients medical record. The paper copy will be destroyed once the data is entered
into REDCap. At the conclusion of the visit, the patient will schedule their 3-month
follow-up study visit. The 3-month follow-up visit will include the same measurements as
listed above. Table 2 provides a broad overview of all data elements to be collected in
Aim 1 and AIM 2 for both patients and providers. For specific quantitative data to be
collected in REDCap for Aim 1.
Once baseline measures are completed, patients without a Fitbit device will be provided
one for the duration of the study, which they get to keep. The same option will be
available for patients who already have a Fitbit but would like one provided by the study
team anyway. The participant will receive their Fitbit device at their baseline study
visit. Participants will also be instructed to wear their Fitbit for a total of 12 weeks.
They will be provided a suggested step count to be accomplished from the health coach
once they meet for the first session . Patients will also install the Fitbit application
and MyChart application as described above and sync the Fitbit with their phone. If
patients do not want to use their own email address or do not already have a gmail
account for the set up of the Fitbit, a gmail (email) account will be created by the
study coordinator for the patient participant. Having the Fitbit synced to the phone and
MyChart application, allows the participant to be able to view their own data.
Patients will have their first meeting scheduled with the health coach (up to 60-minutes
in length, remotely). Patients will then meet with the health coach up to 5 more times
(remotely) for up to 30-minutes per session over the course of the 12 weeks in the study.
Health coaches will schedule meetings with the patients and communicate via Mychart. All
sessions will be telehealth, conducted and recorded over Zoom. Patients will participate
in the study for up to 12 weeks. Patients will receive support from the study team during
the study period to troubleshoot any device related issue.
Aim 2 Procedures:
Patient and Provider interview protocol: Patients and providers will provide verbal
consent and be interviewed by the study research coordinator to assess workflow
acceptability, perceptions, areas for workflow modification, preferences for initial
training, preferences for frequency of review of remote monitoring data, and health coach
interactions. The study team will interview at least 10 patients at the completion of
their 12 weeks to understand their perceptions on the program and supports needed, such
as activity goals, feedback etc. Interviews will be 30-minutes in length, audio recorded
only.
Healthcare Administrator interview protocol: Healthcare administrators will provide
verbal consent and be interviewed on their perceptions of the program and implementation
at their site, including resources, infrastructure, and potential for sustainability.
Interviews will be 30-minutes in length, audio recorded.