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Randomized Controlled Trial of the Behavioral Intervention for Increasing Physical Activity in Multiple Sclerosis
Stephanie L Silveira1, Ariel Kidwell-Chandler2, Trinh L T Huynh2
1Department of Management, Policy, and Community Health, University of Texas Health Science Center at Houston, Houston, TX, USA.
Behavioral Medicine (Washington, D.C.)
|September 17, 2024
Summary
This study evaluated treatment fidelity in a clinical trial for physical activity in multiple sclerosis (MS). High fidelity was achieved through comprehensive monitoring, ensuring reliable intervention delivery for MS patients.
Area of Science:
- Behavioral Medicine
- Clinical Trials
- Multiple Sclerosis Research
Background:
- Treatment fidelity is crucial for the reliability and validity of clinical trials in behavioral medicine.
- Assessing and ensuring fidelity is essential for accurate interpretation of trial outcomes.
Purpose of the Study:
- To report on the outcomes of a pre-planned fidelity monitoring protocol for the Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) Phase-III clinical trial.
- To provide insights into demystifying treatment fidelity monitoring for wider adoption of standard protocols.
Main Methods:
- A comprehensive fidelity monitoring protocol was implemented, incorporating five areas from the NIH Behavior Change Consortium.
- Data sources included coaching call checklists, logs, expert audits, participant engagement metrics, and team meetings.
- Ten coaches were trained to deliver the study protocol, including orientation and behavioral coaching calls.
Main Results:
- The study involved 269 participants (135 in BIPAMS, 134 in WellMS control) over 24 weeks.
- High completion rates for coaching calls were observed (11.81/13 for BIPAMS, 8.19/9 for WellMS).
- A significant percentage of planned audits were completed (62% for BIPAMS, 55% for WellMS), with deviations noted due to the COVID-19 pandemic.
Conclusions:
- The BIPAMS fidelity monitoring protocol demonstrated effective implementation and adherence.
- Insights gained can facilitate the widespread use of standardized treatment fidelity monitoring in behavioral medicine trials.
- Ensuring high treatment fidelity is vital for the integrity of clinical research in conditions like multiple sclerosis.
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