eHealth-Based Behavioral Intervention for Increasing Physical Activity in Persons With Multiple Sclerosis: Fidelity Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: The rate of physical activity is substantially lower in persons with multiple sclerosis (MS) than in the general population. This problem can be reversed through rigorous and reproducible delivery of behavioral interventions that target lifestyle physical activity in MS. These interventions are, in part, based on a series of phase II randomized controlled trials (RCTs) supporting the efficacy of an internet-delivered behavioral intervention, which is based on social cognitive theory (SCT) for increasing physical activity in MS. OBJECTIVE: This paper outlines the strategies and monitoring plan developed based on the National Institutes of Health Behavior Change Consortium (NIH BCC) treatment fidelity workgroup that will be implemented in a phase III RCT. METHODS: The Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) study is a phase III RCT that examines the effectiveness of an internet-delivered behavioral intervention based on SCT and is supported by video calls with a behavioral coach for increasing physical activity in MS. BIPAMS includes a 6-month treatment condition and 6-month follow-up. The BIPAMS fidelity protocol includes the five areas outlined by the NIH BCC. The study design draws on the SCT behavior-change strategy, ensures a consistent dose within groups, and plans for implementation setbacks. Provider training in theory and content will be consistent between groups with monitoring plans in place such as expert auditing of calls to ensure potential drift is addressed. Delivery of treatment will be monitored through the study website and training will focus on avoiding cross-contamination between conditions. Receipt of treatment will be monitored via coaching call notes and website monitoring. Lastly, enactment of treatment for behavioral and cognitive skills will be monitored through coaching call notes among other strategies. The specific strategies and monitoring plans will be consistent between conditions within the constraints of utilizing existing evidence-based interventions. RESULTS: Enrollment began in February 2018 and will end in September 2019. The study results will be reported in late 2020. CONCLUSIONS: Fidelity-reporting guidelines provided by the NIH BCC were published in 2004, but protocols are scarce. This is the first fidelity-monitoring plan involving an electronic health behavioral intervention for increasing physical activity in MS. This paper provides a model for other researchers utilizing the NIH BCC recommendations to optimize the rigor and reproducibility of behavioral interventions in MS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03490240; https://www.clinicaltrials.gov/ct2/show/NCT03490240. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12319.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.058 | 0.054 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.003 | 0.003 |
| Research integrity | 0.009 | 0.008 |
| Insufficient payload (model declined to judge) | 0.056 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".