HeartMapp: Assessment and Treatment for Heart Failure (HeartMapp)
Heart Failure, Cognitive Impairment
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, cognitive impairment, HeartMapp Mobile app, Self-care
Eligibility Criteria
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 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.
Sites / Locations
- University of South Florida
Arms of the Study
Arm 1
Experimental
Experimental Treatment
HeartMapp+CT