HeartMapp: Assessment and Treatment for Heart Failure

NCT03827954 | Completed

• 2 other identifiers: PSC-1014-181R43NR018415-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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

Keywords

Heart failure; cognitive impairment; HeartMapp Mobile app; Self-care

Outcome Measures

Primary Outcomes (1)

• Primary outcome (Feasibility of HeartMapp+CT app usage)

  Above 80% usage of HeartMapp+CT will indicate feasibility of using the app.

  3-months

Secondary Outcomes (6)

• Cognitive outcomes (NIH-Examiner and Neuro QOL questionnaire)

  up to 6-months (baseline and improvement at 3, and 6 months)

• Heart failure Self-care (Self-Care of Heart Failure Index)

  Up to 6-months (baseline and improvement at 3, and 6 months)

• Quality of life related to Heart Failure (Kansas City Cardiomyopathy Questionnaire)

  Up to 6-months (baseline and improvement at 3, and 6 months)

• Physical and Mental Health (PROMISE short-form scale)

  Up to 6-months (baseline and improvement at and 6 months)

• Clinical outcomes (6-minute Walk Test)

  Up to 6-months (baseline and improvement at 3, and 6 months)

Other Outcomes (1)

• Exploratory outcomes (number of hospital and er admissions)

  Up to 6-months (decreased at 3, and 6 months)

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

HeartMapp+CT

Other: HeartMapp+CT

Interventions

HeartMapp+CT OTHER

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.

Experimental Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• Posit Science Corporation: lead
• National Institute of Nursing Research (NINR): collaborator
• University of South Florida: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33559, United States

Location

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ponrathi R Athilingam, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Thomas Van Vleet, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 4, 2019
• Study Start: June 5, 2019
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

US (1)