By InvitationPhase 4

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

United States5 participantsStarted 2026-02-10

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥ 65 years old
✓. 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
✓. Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment
✓. 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

✕. Clinical instability (this N-of-trial is appropriate for stable conditions only)
✕. Decompensated HF
✕. Hospitalized in the past 30 days
✕. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions) at PI discretion
✕. Do not have access to a smartphone or tablet
✕. Estimated life expectancy \<6 months
✕. Moderate-severe dementia or psychiatric disorder precluding informed consent
✕. Language barrier that will preclude informed consent and ability to comprehend study procedures

What they're measuring

Feasibility of Intervention Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).

Intervention Appropriateness Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).

Acceptability of Intervention Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).

Trial details

NCT IDNCT07252310

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More HFrEF - Heart Failure With Reduced Ejection Fraction trials

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adults ≥ 65 years old
✓. 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
✓. Taking less than the maximal dose of beta blocker per physician recommendation at time of enrollment
✓. 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

✕. Clinical instability (this N-of-trial is appropriate for stable conditions only)
✕. Decompensated HF
✕. Hospitalized in the past 30 days
✕. Medication changes or procedures in prior 14 days (to prevent confounding from other interventions) at PI discretion
✕. Do not have access to a smartphone or tablet
✕. Estimated life expectancy \<6 months
✕. Moderate-severe dementia or psychiatric disorder precluding informed consent
✕. Language barrier that will preclude informed consent and ability to comprehend study procedures

What they're measuring

Feasibility of Intervention Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).

Intervention Appropriateness Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).

Acceptability of Intervention Measure Score

Timeframe: End of intervention visit, assessed between Week 6 (minimum) and Week 18 (maximum).