HeartMapp: Assessment and Treatment for Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT03827954

Run by

Posit Science Corporation

People needed

28

Starts

2019-06-05

Expected to finish

2021-05-24

Last updated by the study team

2021-08-24

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 within a month of the consent date,
• 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 ≥16,
• 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.

Where it is running

• University of South Florida — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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