HeartMapp: Assessment and Treatment for Heart Failure

Summary

In the current application, the 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 Heart Failure (HF). Presently, HeartMapp includes physiological modules (PM) that support self-monitoring and exercises that promote heart health, and cognitive modules (CM) that track and enhance cognitive functions. During the first three-months, the investigators will finalize the cognitive training modules within HeartMapp and release through the quality management system. At the completion of software development, the investigators propose to test the relevant usage and progression variables of the algorithm that will be used to direct engagement with the app.

The investigators will conduct a single arm, open label, pilot clinical trial to examine feasibility and initial efficacy of the HeartMapp+CT (HeartMapp and computerized plasticity-based adaptive cognitive training). The term "CT" refers to computerized training. The study will enroll 32 adults aged 40 and older with a diagnosis of HF and over sample by 25% to reduce attrition for a total of 24 participants enrolled at the end. Participants will complete follow-up assessments at 3- and 6-months after enrollment.

Conditions

• Heart Failure
• Cognitive Impairment

Interventions

OTHER

HeartMapp+CT

HeartMapp+CT is a mobile system that includes physiological modules that support self-monitoring and exercises that promote heart health, and computerized plasticity-based adaptive cognitive training modules that train participants to enhance cognitive functions and ultimately heart failure outcomes.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of South Florida

  collaborator OTHER

• Posit Science Corporation

  lead INDUSTRY

Principal Investigators

• Ponrathi R Athilingam, PhD · University of South Florida

• Thomas Van Vleet, PhD · Posit Science Corporation

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-05

Primary Completion

2021-05-24

Completion

2021-05-24

Countries

• United States

Study Locations