A Preliminary Study for INFORMED
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Parag Goyal, MD, MSc · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- 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.