Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial.
Study Goal
The researchers aimed to determine whether a pedometer-based walking intervention, combined with face-to-face sessions and regular telephone contact, improves functional capacity in heart failure patients.
Results Summary
The study is ongoing, but the abstract outlines the planned statistical analyses to evaluate changes in the 6-minute walk test distance over 6 months. Adverse events are monitored, but no specific results are reported yet.
Population
Heart failure patients with reduced ejection fraction.
Effective Dosage
Not specified (pedometer-based walking intervention).
Duration
6 months with a 6-month follow-up.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact | increase | functional capacity | heart failure patients | - | improves | #1 |
walking | increase | functional capacity | heart failure patients | - | can potentially improve | #2 |
physical activity | neutral | heart failure with reduced ejection fraction | patients | - | is an effective management strategy | #3 |
BACKGROUND: Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. OBJECTIVES: The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. METHODS: The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. DISCUSSION: The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns. CONCLUSIONS: The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).