Status:
COMPLETED
HeartMapp: Assessment and Treatment for Heart Failure
Lead Sponsor:
Posit Science Corporation
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
University of South Florida
Conditions:
Heart Failure
Cognitive Impairment
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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 ecolog...
Detailed Description
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 target...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03827954
Start Date
June 5 2019
End Date
May 24 2021
Last Update
August 24 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Florida
Tampa, Florida, United States, 33559