Comparison · NCT02506244-233a0038
Immediate Monitoring vs Delayed Monitoring: Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Immediate Monitoring vs Delayed Monitoring: Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group. Trial comparisons, record NCT02506244-233a0038. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02506244-233a0038
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0388 | 0.0298 | 0.0504 | wilson | |
| Risk in group 2 | 0.00928 | 0.00532 | 0.0162 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0295 | 0.0182 | 0.0418 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.18 | 2.24 | 7.79 | log | |
| Odds ratio, group 1 over group 2 | 4.31 | 2.29 | 8.1 | log | |
| Number needed to treat, for one more participant with the outcome on Immediate Monitoring than on Delayed Monitoring | 33.9 | 23.9 | 55 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Immediate Monitoring | Individuals randomized to immediate monitoring will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of the 4 month monitoring period of time 0 to 4 months.~Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) continuously over the 4 month monitoring period.~iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch~Wristband by Amiigo: Determines pulse rate using photoplethysmography. | 53 | 1,366 | OG000 |
| Group 2 | Delayed Monitoring | Individuals randomized to delayed monitoring will receive usual care for 4 months after which they will receive the ZIO XT patch sensor and wear it for the first and last 2 week period of study months 4 through 8.~Note: Approximately 250 consenting participants will also be invited to participate in a sub-study to wear an additional monitoring device (Amiigo wristband) daily for months 4 through 8.~iRhythm ZIO XT Patch: Single-lead ECG monitoring via a wearable patch~Wristband by Amiigo: Determines pulse rate using photoplethysmography. | 12 | 1,293 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group
- Description
Incidence of newly diagnosed AF as defined by at least 30 seconds of AF or atrial flutter at the end of the 4 month monitoring period compared to the delayed monitoring cohort (primary) and observational control (secondary)
- Time frame
- End of 4 month monitoring period
- Population
- In the intention-to-treat analysis of the randomized clinical trial, we analyzed the incidence of new AF cases in the immediate monitoring group vs the delayed monitoring groups.
Source ClinicalTrials.gov
Trial
- Title
- mHealth Screening to Prevent Strokes
- NCT number
- NCT02506244
- Phases
- NA
- Conditions
- Atrial Fibrillation
- Interventions
- iRhythm ZIO XT Patch, Wristband by Amiigo
- Lead sponsor
- Scripps Translational Science Institute
- Results first posted
- 2022-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02506244?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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