Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform

The Intermountain Heart Institute will collaborate with Savvysherpa Inc to develop a
sensor-based digital platform based on MAWDS. (MAWDS is Intermountain's acronym that stands
for Medications, Activity, Weight, Diet, Symptoms; used across Intermountain Healthcare to
represent the most important concepts and skills to teach heart failure patients) This will
be used to deliver simple, home-based interventions via an app on the subject's iPhone. The
app will be programmed to send notifications to the subject to enter their MAWDS data and
perform a 6-minute walk test at specific time points during the study. Written informed
consent will be obtained from each subject prior to participation. A study team member will
register eligible subjects as well as assist them with the iPhone and HealthKit set-up and
train them on the app usage. Protocol-required information will be obtained from subject's
medical records (collected as part of their usual medical care). Subjects will be asked to
enter data into the MAWDS iPhone app at specified intervals for a period of 3 months. The
data, with the date and time it was entered, will be posted to a study-specific database.
Periodically, the MAWDS app will query activity data from HealthKit and post that to the same
database. Scheduled notifications will appear in the iPhone's Notification Center, reminding
the subject to use the app. To assess subject engagement, the app will collect and store
standard usage statistics provided by the iOS (e.g., number of times and duration the app is
used per day, number of data entries, etc). The subjects' electronic medical records will be
reviewed for a period of 3 months following enrollment, focused on healthcare utilization
(e.g., hospital readmissions, mortality, changes in Intermountain HF (heart failure) Risk
Score, etc). All information will be made part of the study-specific database. Follow-up
phone calls will be done, as needed, within the first 2 weeks after enrollment to remind
subjects to activate the app, ensure that the subjects are using the app appropriately, and
address any issues noted on monitoring the data collected via the app. Subjects will have no
other research-related clinic visits or in-person follow-up evaluations, other than the visit
for obtaining informed consent, registration and setting up of the app, and follow-up
telephone calls as needed. Upon completion of the study, the app on the subject's iPhone will
be disabled and Savvysherpa will disconnect the "backend" data capture. Data will no longer
be collected from the subject and his/her medical records will no longer be accessed.

Inclusion Criteria:

1. Male or female > 18 years of age

2. Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of any study procedures

3. Documentation of heart failure of any etiology, using standard of care criteria for
diagnosis, and based on clinical assessment of the Principal Investigator and/or his
delegate

4. Possess (and are comfortable using) an iPhone of appropriate age (model 5S or newer,
since these models have a motion coprocessor that can run iOS 8 or later, as needed to
run the app)

5. Willing and able to comply with the instructions for entering their MAWDS data into
the app installed in their iPhones

Exclusion Criteria:

1. Significant and/or severe co-morbidities, as assessed by the Principal Investigator
and/or his delegate

2. Currently in hospice care or planned discharge to hospice care at home or to a hospice
care facility

3. Inability to read and/or understand English (Non-English speaking and reading
participants will be excluded since the program requires a variety of communications,
not all of which have been validated in a language other than English).

4. Other conditions that in the opinion of the Principal Investigator and/or
Sub-Investigator may increase risk to the subject and/or compromise the quality of the
clinical trial

5. The Study Clinician(s) determine(s) that the subject is not eligible for participation
in this research study