Mobile Application for Patient Engagement and Physician-Directed Remote Management of Heart Failure

The primary outcome will be the difference in the medication optimization score at 90 days between the intervention and control group. The MOS is a percent between 0 (least optimized) and 100 (most optimized), which represents the extent of medication optimization that needs to be performed. Inputs for the score include medications, vital signs, and laboratory values, and thus, the score accounts for contraindications to medical therapy titration. The score has been shown to correlate with clinical outcomes in two large randomized controlled trials.

The secondary outcome will be heart failure symptoms as assessed by the difference between the intervention and the control groups in the 23-item Kansas City Cardiomyopathy Questionnaires (KCCQ-23) clinical summary score at 90 days.

The KCCQ-23 quantifies patients' health status over the prior 2 weeks and has extensive data supporting its validity, reliability, and sensitivity to clinical change. Scores will be transformed into a 0-100 point rating, with lower scores representing worse health status.

Kansas City Medical Optimization (KCMO) is the average total daily dose for each eligible Guideline-Directed Medical Therapy (GDMT) drug class divided by its target dose. The investigators will compare this score with the primary outcome measure.

The Modified Continuous 4-Pillar Score (C4P) score is a continuous version of the 4P Intensification Score, where each dose escalation leads to an increase in the score rather than assigning the same points to a range of increasing GDMT doses. For Beta Blockers, ACEI/ARBs, MRAs, and SGLT2 inhibitor, the C4P score is calculated as 2 + 2 × (% of target daily dose) for patients on therapy to a max score of 4. For ARNI therapy, the score is calculated as 4 + 2 × (% of target daily dose). The score range is from 0 to 18. A higher score is a better outcome.

Participant deaths

Participant hospitalization due to heart failure. Heart failure hospitalizations will be defined as outlined by the Heart Failure Collaboratory and Academic Research Consortium

Participant visits to the emergency department for heart failure. Emergency department visits will use a modified version of the criteria of the Heart Failure Collaboratory and Academic Research Consortium without the 24 hour hospital admission requirement.

Participant undergoes outpatient intravenous diuresis.

The investigators will evaluate process measures related to use of the intervention and downstream clinical processes. This will include patient engagement with the ENGAGE-HF mobile application and the subcomponents of engagement with respect to the different aspects of the mobile application.

The Mini-Cog is a brief screening tool used to assess cognitive function, particularly memory and executive function, in study participants. The assessment consists of two components: a three-item recall test and a clock-drawing test (CDT). The three-item recall test evaluates short-term memory by requiring participants to remember and later recall three unrelated words. The CDT assesses executive function and visual-spatial skills by requiring participants to draw a clock with a specified time.

In the Memory Recall - Immediate part of the INTACT neurocognitive assessment, participants recall and select five animal names. Measured by the average number of correct responses (0-5) and completion time (seconds).

In the Choice Reaction Time part of the INTACT neurocognitive assessment, participants identify the direction of an arrow in an odd-colored block among three. Measured by the proportion of correct responses (true/false) and average reaction time (seconds).

In the Visual Paired Associates part of the INTACT neurocognitive assessment, participants match image pairs after learning them. Measured by the proportion of correct responses (true/false) and average reaction time (seconds).

In the Digit Symbol Matching part of the INTACT neurocognitive assessment, participants match symbols to numbers using a reference. Measured by the proportion of correct responses (true/false) and average reaction time (seconds).

In the Spatial Memory part of the INTACT neurocognitive assessment, participants recreate increasingly complex block designs. Measured by the proportion of correct responses (true/false) and average reaction time (seconds).

In the Memory Recall - Delayed part of the INTACT neurocognitive assessment, participants recall the five animal names from the immediate recall test after a delay. Measured by the average number of correct responses (0-5) and completion time (seconds).