Login / Signup

Factors contributing to fidelity in a pilot trial of individualized resistant starches for pediatric inflammatory bowel disease: a fidelity study protocol.

Gisell CastilloDavid R MackManoj M LaluRuth SingletonDean A FergussonAlain StintziMegan HarrisonJustin Presseau
Published in: Pilot and feasibility studies (2021)
The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.
Keyphrases
  • study protocol
  • clinical trial
  • randomized controlled trial
  • phase iii
  • phase ii
  • open label
  • current status
  • electronic health record
  • mental health
  • big data
  • artificial intelligence
  • young adults