eHealth-Based Behavioral Intervention for Increasing Physical Activity in Persons With Multiple Sclerosis: Fidelity...

Area of Science:

• Behavioral Science
• Clinical Trials
• Public Health

Background:

• Physical activity levels are significantly lower in individuals with multiple sclerosis (MS) compared to the general population.
• Behavioral interventions targeting lifestyle physical activity can reverse this trend in MS.
• Previous phase II randomized controlled trials (RCTs) demonstrated the efficacy of an internet-delivered behavioral intervention based on social cognitive theory (SCT) for increasing physical activity in MS.

Purpose of the Study:

• To outline the strategies and monitoring plan for a phase III RCT, based on the National Institutes of Health Behavior Change Consortium (NIH BCC) treatment fidelity workgroup.
• To ensure the rigorous and reproducible delivery of an internet-delivered behavioral intervention for increasing physical activity in MS.

Main Methods:

• The Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) study is a phase III RCT utilizing an internet-delivered behavioral intervention based on SCT with video coaching.
• The fidelity protocol adheres to the five areas outlined by the NIH BCC, including provider training, expert auditing of calls, website monitoring, and monitoring of behavioral/cognitive skill enactment.
• Strategies ensure consistent intervention dose, plan for setbacks, and prevent cross-contamination between study conditions.

Main Results:

• Enrollment for the BIPAMS study began in February 2018 and concluded in September 2019.
• Study results are anticipated to be reported in late 2020.

Conclusions:

• While NIH BCC fidelity-reporting guidelines exist, practical protocols are limited.
• This represents the first fidelity-monitoring plan for an electronic health behavioral intervention aimed at increasing physical activity in MS.
• The paper offers a model for researchers to optimize the rigor and reproducibility of behavioral interventions in MS using NIH BCC recommendations.