HFrEF - Heart Failure With Reduced Ejection Fraction, Heart Failure, Heart Failure, Systolic, Heart Diseases
Conditions
Keywords
HFrEF, App, N-of-1, GDMT, StudyU, Beta Blocker
Brief summary
This study will look at whether using a phone app called StudyU can help people with Heart Failure with Reduced Ejection Fraction (HFrEF) reach their recommended dose on their beta blocker.
Detailed description
The overarching goal of this study is to determine feasibility of the StudyU app in N-of-1 trials. The study intervention is N-of-1 trials, facilitated by a mobile-based application, StudyU. The study team will utilize a single-arm sequential design N-of-1 study in which subjects who are not yet at the GDMT for beta blockers will test multiple doses of GDMT to understand the maximally tolerated dose using an N-of-1 trial format. This is similar to an approach used in a previous study, Pilot Deprescribing N-of-1 Trials for beta blockers in HFpEF (NCT04757584) but will test the addition of a mobile-based app to collect vital signs, monitor side effects, and monitor patient-reported outcomes.
Interventions
DRUGbeta blockers
Subjects will remain on their current home dose of beta blocker (as prescribed by their treating physician prior to enrollment) during Period 1. In Period 2, the dose will be increased -either doubled or by 50%-to support progression toward the guideline-directed medical therapy (GDMT) target. may choose to continue on the tested dose and conclude the study, or request additional information before selecting their preferred dose. If both the participant and the study clinician agree that further evaluation is needed, a third period will be initiated. In this period, the dose may again be increased-by 50% or doubled relative to the Period 2 dose-if tolerated and agreed upon by the participant. If the new dose is well-tolerated and the participant agrees to continue with dose escalation after reviewing their data, the dose will be increased again-either doubled or increased by 50%-for the next period (Period 3). The study team will continue to collect data.
DEVICEStudyU Application
StudyU is a novel mobile app developed for the design of and conduct of N-of-1 trials. StudyU consists of the StudyU Designer, a web platform and mobile app, accessible through the website https://designer.studyu.health; the StudyU App for smartphones, which can be downloaded from Apple and Google app stores, and the secure backend where data is stored. All components of StudyU were developed by Dr. Stefan Konigorski and his colleagues at Hasso-Plattner Institute (HPI) for Digital Engineering at the University of Potsdam. The StudyU platform allows investigators to easily operationalize their study processes in the StudyU designer. In the StudyU designer, investigators indicate at which frequency subjects will complete assessments. For this pilot trial, a WCM-specific instance of StudyU will be developed and hosted on the secure WCM server. Only the WCM study team will have access to the subject data from the StudyU App.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 65 years old 2. A history of HFrEF per electronic medical record review/clinician impression that is defined as an EF \<50% that is shown from any imaging modality 3. Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment 4. Access to a smartphone or device that can perform many of the same functions as a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications
Exclusion criteria
1. Clinical instability (this N-of-trial is appropriate for stable conditions only) 1. Decompensated HF 2. Hospitalized in the past 30 days 3. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions) at PI discretion 2. Do not have access to a smartphone or tablet 3. Estimated life expectancy \<6 months 4. Moderate-severe dementia or psychiatric disorder precluding informed consent 5. Language barrier that will preclude informed consent and ability to comprehend study procedures 6. History of noncompliance or inability to complete study procedures 7. Enrollment in a clinical trial not approved for co-enrollment 8. Any condition that, in Principal Investigator or treating physician's opinion, makes the patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure Score | End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | The Feasibility of Intervention (FIM) measure is a survey that evaluates an intervention's practicality. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher feasibility and lower indicating less feasibility. Total scores range from 4 to 20. A score of 4 indicates low feasibility and a score of 20 indicates strong feasibility. |
| Intervention Appropriateness Measure Score | End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | The Intervention Appropriateness Measure (IAM) is a survey that evaluates an intervention's suitability and compatibility. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher appropriateness and lower indicating less appropriateness. Total scores range from 4 to 20. A score of 4 indicates low appropriateness and a score of 20 indicates strong appropriateness. |
| Acceptability of Intervention Measure Score | End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | Acceptability of Intervention Measure (AIM) is a survey that evaluates how agreeable an intervention is to participants. Questions are ranked on 1- to 5-point Likert scales, with higher scores indicating higher acceptability and lower indicating less acceptability. Total scores range from 4 to 20. A score of 4 indicates low acceptability and a score of 20 indicates strong acceptability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in KCCQ-12 Score | Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) is a heart failure-specific health status survey. Questions are ranked on 5- to 7-point Likert scales, with higher scores indicating better health status and lower indicating worse health status. Total scores range from 0 to 100. A score of 0 indicates the worst health statues and a score of 100 indicates the best health status score. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose. |
| Change in PROMIS-29 Score | Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | Patient-Reported Outcome Measurement Information System-29 (PROMIS) is a health-related quality of life survey, with questions from 7 domains: depression, anxiety, physical function, pain interference, pain intensity, sleep disturbance, and ability to engage in social roles and activities. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating better quality of life, and lower scores indicating poorer quality of life. Scores are reported for each domain. Total scores range for each domain except pain intensity is from 0 to 100. A score of 0 indicates no symptoms, whereas a 100 indicates extremely severe symptoms for each domain. For the pain intensity domain, there is a pain rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose. |
| Change in PROMIS CF-SF 6a Score | Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | Patient-Reported Outcome Measurement Information System Cognitive Function - Short Form 6a (PROMIS CF-SF) Score is a health-related quality of life survey that focuses on the cognitive function domain. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating higher cognitive function, lower scores indicate lower cognitive function. Total scores range from 0 to 100. A score of 0 indicates worst possible cognitive function, whereas a 100 indicates best possible cognitive function. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose. |
| Change in PROMIS Sexual Function Score | Baseline, assessed on Day 1. End of Period visit, assessed between Week 3 (minimum) and Week 18 (maximum). End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum). | Patient-Reported Outcome Measurement Information System (PROMIS) Sexual Function Score is a health-related quality of life survey that focuses on the sexual function domain. Questions are ranked on a 5-point Likert scale, with higher scores at times indicating higher sexual function, lower scores indicate lower sexual function. Total scores range from 0 to 100. A score of 0 indicates no sexual interest/function/satisfaction whereas a 100 indicates high sexual interest/function/satisfaction. The change in score is comparing the baseline dose with the changed dose in subsequent periods. End of Period visits can convert to end of intervention if participants choose that dose. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORParag Goyal, MD, MSc
Weill Medical College of Cornell University
Outcome results
None listed