Pilot Study of StudyU for N-of-1 Trials in HFrEF Patients (N-of-1 App)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HFrEF - Heart Failure With Reduced Ejection Fraction Heart Failure Heart Failure, Systolic Heart Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GDMT (Beta Blockers)

This study consists of a single arm. Subjects will complete study activities remotely. Following enrollment, daily assessments will be conducted using the StudyU mobile application. Additional assessments will occur at the end of each study period, completed by phone, WCM Zoom, or via email, depending on subject preference. The study involves testing multiple doses of each subject's guideline-directed medical therapy (GDMT), specifically beta-blockers. Doses will include the subject's current home dose (as prescribed by their treating physician prior to enrollment), as well as one or more increased -and, if needed, decreased-doses that are near or at the guideline-directed maximum. All dosing decisions will be made collaboratively by the PI, the subject's clinician, and the participant, taking into account titration guidelines, physician guidance, and subject symptoms and preferences. Each subject will complete a minimum of two periods. The number of periods is adaptive.

Group Type EXPERIMENTAL

beta blockers

Intervention Type DRUG

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.

StudyU Application

Intervention Type DEVICE

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.

Interventions

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beta 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.

Intervention Type DRUG

StudyU 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No