HeartMapp: Assessment and Treatment for Heart Failure

Heart failure (HF) is a progressive disease that affects 6.5 million Americans and is
projected to reach 10 million by 2020. Presently, treatments for HF are largely comprised of
drug therapies targeting pathophysiology and self-administered therapies that require
patients to learn, accurately recall and routinely execute complex self-care practices. HF
patients are expected to monitor their weight, diet and manage their medications, and are
also required to recognize, monitor and report HF related symptoms. However, adopting
self-care behaviors are often challenging for patients due to concomitant cognitive
impairments, as shown in 30% to 80% of HF patients; a condition which is often complicated by
insufficient social support. Multiple studies have shown a direct relationship between
cognitive deficits and difficulty with self-care. Thus, there is currently an urgent unmet
need for novel patient-centered interventions that are easy to use by older adults with HF
that suffer cognitive difficulties and lack social support.

In the current application, investigators propose to elaborate upon, reconstruct and advance
to pivotal trial readiness a recently validated mobile application (HeartMapp), designed for
the ecological momentary assessment and treatment of individuals with HF. Presently,
HeartMapp includes physiological modules (PM) that support self-monitoring and exercises that
promote heart health, and cognitive modules (CM) that train participants to enhance cognitive
functions. The Posit Science Corporation team of developer and neuroscientists will closely
collaborate with investigators at University of South Florida (Drs. Athilingam and Labrador),
inventors of the initial version of HeartMapp, to include a clinician-facing dashboard and
reporting utility comprised of both PM and CM performance and progress tracking metrics. This
Point-of-Care (POC) device will also aid clinical studies of cardiovascular, lung, and blood
diseases and disorders by providing continuous monitoring data collected remotely to serve as
an open channel between patients and clinicians. A recent usability study of the HeartMapp PM
conducted by co-investigator Dr. Athilingam in 25 HF patients was successful; patients found
the app easy to use, helpful and engaging. A concurrent pilot clinical trial that examined
only CM in 17 HF patients demonstrated that CM improved memory, cognitive speed of
processing, and showed trends for improved everyday function and HF self-care. Across all
functional outcomes measured, the CM group showed better function post-training relative to
controls. Similarly, in our prior research, and in the successful development of related
products at Posit Science that demonstrated a core ability to develop multimodal (i.e.,
assessment and treatment) applications with compelling user experiences that drive strong
performance improvements across multiple performance domains. For the current project.

The investigators will conduct a prospective, parallel arm, double blinded, randomized,
controlled pilot clinical trial to examine feasibility and initial efficacy of the
HeartMapp+CT (HeartMapp and computerized plasticity-based adaptive cognitive training)
compared to an attention control condition who will use the CHF Info App+CT (CHF Info App and
commercially-available computerized training). the study will enroll 49 adults aged 40 and
older with a diagnosis of HF and over sample by 18% to reduce attrition for a total of 49
participants. Eligible participants will be randomized to either HeartMapp+CT or an active
control condition using the CHF Info App+CT. Both groups will complete follow-up assessments
at 3- and 6-months after enrollment.

- The primary outcome is to test the feasibility and efficacy of using HeartMapp with
computerized plasticity-based adaptive cognitive training (HeartMapp+CT), which will be
quantified by measuring app usage and engagement with the apps. Engagement with
cognitive training will be calculated as percentage of participant's who complete at
least 20 hours of assigned cognitive training included in HeartMapp. App usability and
engagement will be assessed by App access by participants; Accessing App components at
least 80% of the days (72 days out of 90-days) will be used to determine app engagement.

- The secondary outcomes are improvement in cognitive function and HF self-care. If an
effect sizes on Cohen's d of d=0.25 or greater relative to controls for these outcomes,
HeartMapp will be considered potentially efficacious.

- Exploratory outcomes include improvement in quality of life, global health, medication
adherence, heart rate variability and hospital admission. The investigators will
calculate effect sizes using Cohen's d on these outcomes to inform future studies.

Inclusion Criteria:

Selection of participants is based on their condition HF and is not based on gender or
ethnic considerations, although these are expected to reflect the diverse population of the
United States; ethnic minorities will be included when available and recruiting efforts
will target a balanced enrollment.

- Age 40 years or above,

- Clinical diagnosis of HF as defined by the International Classification of Diseases
(ICD-10 codes) and recent hospitalization for HF,

- New York Heart Association (NYHA) classification II-III,

- Ability to speak, understand and read English,

- Adequate hearing, as determined by response to a pure-tone stimulus at 70 decibels or
better for 1 & 2 kHz in each ear, measured using the Welch-Allyn.

- Intact vision (visual acuity of 20/50 or better, as assessed by a Snellen chart per
standard procedure).

Exclusion Criteria:

Participants meeting any of the following exclusion criteria at baseline will be excluded
from study participation.

- Listed for heart transplant as status 1A,

- Enrolled in a palliative or hospice care program,

- Currently enrolled in another research study,

- Concurrent or previous participation in a cognitive training study,

- Self-reported vision, hearing, or motor difficulties that would interfere with the
ability to complete the study interventions,

- Self-reported diagnosis of dementia, stroke, traumatic brain injury, brain tumor, or a
neurological disorder that affects cognition or would interfere with the ability to
benefit from the study intervention (e.g., Parkinson disease, multiple sclerosis), or
any other unstable medical conditions that is predisposing to imminent cognitive or
functional decline (e.g., undergoing chemotherapy or radiation),

- Presence of disability (e.g., aphasia) that may prevent them from completing study
related activities,

- Severe depressive symptoms screened using PHQ-9 with score ≥7,

- History or current diagnosis of organic mental disorder, schizophrenia,
schizoaffective disorder, delusion disorder, psychotic disorder, bipolar disorder,
and/or mood congruent or mood incongruent psychotic features or disorders,

- Evidence of dementia with a score of <20 in the Montreal Cognitive Assessment, (MoCA),

- Shows signs of intoxication due to current substance abuse (including alcohol and/or
illegal drugs),

- Suicidal thoughts or ideations, or suicide-related behaviors using Columbia-Suicide
Severity Rating Scale with 2 months of consent date.

Participants who are excluded due to depression, suicidal thoughts or ideation and/or
dementia, poor vision or hearing will be referred to the appropriate professionals for
thorough evaluation and treatment.