Development of a Diet Intervention Fidelity Protocol for a Randomized Clinical Trial of Acute Ischemic Stroke Survivors

Objectives: The impact of nutrition on chronic disease outcomes can be profound, but without periodic assessment of treatment fidelity, one cannot know whether the outcomes are due to an effective intervention or some other unknown factors. Repeated measurements of fidelity across all treatments will ensure the likelihood that treatment differences are maintained for the duration of the trial. We summarize our efforts to implement treatment fidelity assessments throughout the ongoing phase III dietary intervention trial known as Nutrition effects on brain Outcomes and Recovery In Stroke after Hospitalization (NOURISH). Methods: The trial is designed to test whether the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) adoption by acute stroke survivors will slow annual cognitive decline when compared to those assigned enhanced usual care. (ClinicalTrials.gov ID: NCT04337255). Five key components of treatment fidelity were developed for the NOURISH trial based on those proposed by Borelli and colleagues.1 These include:1) Study Design and Protocol Timeline; 2) Training; 3) Treatment Delivery: content and process of the intervention; 4) Treatment Receipt; and 5) Treatment Enactment. For treatment delivery, every 6 months a 5% random sample of audio or video recorded sessions between interventionists and participants are reviewed and scored. For treatment receipt, we use Twilio™ (a platform with automated text messages to be sent at pre-specified times) to periodically assess the participants' ability to receive, understand and process the information discussed during sessions/contacts. Finally, contact completion and diet adherence scores are monitored for treatment enactment. Results: N/A. Conclusions: Periodic component assessments throughout the study will provide a more standardized intervention across interventionists and afford an intervention that is responsive to the diverse and ever-changing needs of participants during stroke recovery. 1Borrelli B, et al. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol. 2005;73(5): 852-60.