Randomized Controlled Trial of the Behavioral Intervention for Increasing Physical Activity in Multiple Sclerosis Project: Fidelity Monitoring and Outcomes

Abstract

Treatment fidelity is a key component for assessing the reliability and validity of clinical trials in behavioral medicine. This manuscript reports on the outcomes of a pre-planned fidelity monitoring protocol for a Phase-III clinical trial, project Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS). The fidelity monitoring protocol included the five areas of the National Institutes of Health Behavior Change Consortium with primary data sources including: coaching call checklists, coaching logs, auditing of coaching calls by experts, behavioral resource bank within the treatment group, review of participant website log-ins, review of participant self-monitoring, and team meetings for discussing participant progress and protocol adherence. The fidelity monitoring protocol was implemented across six waves of participants, and a final sample of 269 participants (i.e., n = 135 in BIPAMS intervention and n = 134 in WellMS control) completed the 24-week study. Ten coaches were comprehensively trained to implement the study protocol, which included an orientation call and one-on-one behavioral coaching calls. Among BIPAMS participants, an average of 11.81/13 scheduled calls were completed, and 96 (62% of planned) were audited by an expert. Among WellMS participants, an average of 8.19/9 calls were completed, and 54 (55% of planned) audits were completed. Unplanned protocol deviations included inability to complete live call audits during the COVID-19 pandemic lockdown and changes in coaching criteria to accommodate unanticipated medical conditions and graduations. This manuscript provides an example and insights for demystifying treatment fidelity monitoring to help facilitate wide-spread use of standard protocols.