NCT05585125

A Preliminary Study for INFORMED

Enrolling by Invitation
PHASE4Ages 65+Interventional
Weill Medical College of Cornell University
~20 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:Beta blocker

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviews
Measured over From the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.
+1 more outcome measured
Heart Failure
Heart Failure, Diastolic
Heart Failure With Preserved Ejection Fraction
Cardiac Failure
Heart Diseases
1 sites across 1 states
New York1
  • Parag Goyal, MD, MSc · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Change in participant's confidence regarding their preference to continue or discontinue beta-blocker, as assessed by qualitative interviewsFrom the date of their baseline visit to the date of their last follow-up interview, assessed up to 88 weeks.

    Qualitative interviews will be conducted to assess the change in confidence through their experience participating in N-of-1 trials. Directed content analysis methods will be used to develop relevant categories and themes from interview transcript data. Transcripts will be coded and analyzed by two team members, consulting additional members to establish consensus where needed. Inter-rater reliability between coders will be established using Cohen's Kappa score.

  • Change in participant decision-confidence, as measured by the Decisional Conflict Scale (DCS)From the date of their baseline visit, to the date of their end of intervention visit, assessed up to 36 weeks.

    Measures participant perceptions of uncertainty in decision-making, factors contributing to uncertainty, and effective decision-making. A set of 16 questions with responses ranging from "strongly agree" = (0) to "strongly disagree" = (4). Scores are summed together to produce an overall score between 0 and 100. Lower scores indicate feeling informed and low decisional conflict whereas higher scores indicate feelings of uncertainty and high decisional conflict.