A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.
Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.
Yale New Haven Hospital
New Haven, Connecticut, United States
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, United States
MercyOne Northeast Iowa Family Medicine and Residency
Waterloo, Iowa, United States
Time to Change or Decision That Heart Failure Therapy is Optimal
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy.
Time frame: Randomization to 6 months
Time to change or decision that heart failure therapy is optimal
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy, time to change or decision that dose is optimal.
Time frame: Baseline to 6 months
Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)
Health-ITUES-HCP will be used to assess the healthcare provider's experience with the digital health tool(s) and data presentation. The scale consists of 36 items. A higher score indicated higher perceived usability of the technology.
Time frame: Week 24
Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores
Health-ITUES-Subject will be used to assess the participant's experience with the digital health tool(s). The scale consists of 36 items. A higher score indicated higher perceived usability of the technology.
Time frame: Week 24
Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy
Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
Time frame: Baseline and Week 24
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Virtua Health Inc.
Voorhees Township, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Diagnostic Cardiology Group
Chattanooga, Tennessee, United States
Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC
Tullahoma, Tennessee, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores
The KCCQ-23 is a 23-item questionnaire to measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. All items are measured on a Likert scale with 5-7 response options. Scores for each item are standardized to range from 0 to 100 with higher scores indicating better health status, fewer symptoms, and greater disease-specific health-related quality of life.
Time frame: Baseline and Week 24