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

Abstract

Background The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. Methods We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. Discussion 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.

Experience of providing care to a family member with Crohn's disease and a temporary stoma: A qualitative study

“…As a result of CD develops progressively in the way of remission-relapse-remission, CD patients often have frequent demands for medical services such as multiple operations, routine reexamination, medical treatment, which will increase patients' dependence on their main caregivers to accompany them to seek medical treatment and provide daily care [ 26 ]. Bedford's study have shown that the level of stoma acceptance of patients is significantly related to the time after colostomy [ 27 , 28 ].…”

A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric Inflammatory Bowel Disease

“…A comprehensive description of the methods of the present study can be found in the study protocol [ 12 ]. It was originally planned that the present study would include only participants and caregivers of the RSP trial.…”

A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric IBD

“…Detailed trial information on both trials can be found on the clinical trials registry (https://clinicaltrials.gov RSP Identifier: NCT0452227; MEND Identifier: NCT04520594). A comprehensive description of the methods for the present study can be found in the study protocol (11). It was originally planned that the present study would include only participants and caregivers of the RSP trial.…”