Heart Failure
Conditions
Keywords
Digital health, Remote monitoring, Wearable device
Brief summary
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.
Interventions
DEVICEBiobeat Wrist Watch
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.
OTHERStandard of Care
Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* History of chronic heart failure. * Ejection fraction equal to or below 40%. * New York Heart Association (NYHA) class II to class III. * Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.
Exclusion criteria
* Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney). * Currently in an investigational device or drug study. * Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Change or Decision That Heart Failure Therapy is Optimal | Randomization to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to change or decision that heart failure therapy is optimal | Baseline to 6 months | 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. |
| Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP) | Week 24 | 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. |
| Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores | Week 24 | 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. |
| Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy | Baseline and Week 24 | Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied. |
| Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores | Baseline and Week 24 | 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. |
Countries
United States
Outcome results
None listed