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Study closed prematurely due to enrollment challenges exacerbated by COVID-19.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Tools + Standard of Care | Experimental |
| |
| Standard of Care | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biobeat Wrist Watch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Randomization to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| Cardiology Associates of Fairfield County, PC |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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|
| Standard of Care | Other | Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. |
|
| 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. | 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. | 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. | Baseline and Week 24 |
| 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. | Baseline and Week 24 |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| MercyOne Northeast Iowa Family Medicine and Residency | Waterloo | Iowa | 50702 | United States |
| Virtua Health Inc. | Voorhees Township | New Jersey | 08043 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Diagnostic Cardiology Group | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC | Tullahoma | Tennessee | 37388 | United States |
| Inova Heart and Vascular Institute | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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