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Trial · NCT02506244

mHealth Screening to Prevent Strokes

NCT02506244, Not applicable, Completed, Scripps Translational Science Institute; results first posted 2022-12-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. mHealth Screening to Prevent Strokes. Trials, record NCT02506244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02506244

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
mHealth Screening to Prevent Strokes
NCT number
NCT02506244
Status
Completed
Phases
Not applicable
Enrollment
6,135 participants, actual
Lead sponsor
Scripps Translational Science Institute
Conditions
Atrial Fibrillation
Interventions
iRhythm ZIO XT Patch, Wristband by Amiigo
First posted
2015-07-23
Last updated
2022-12-08
Results first posted
2022-12-08

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring GroupEnd of 4 month monitoring period
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)
SecondaryPrevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls1 yearIn the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring GroupEnd of 4 month monitoring periodIn 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.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPrevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls1 year906 participants that were in the immediate monitoring group had 12 months of follow-up data, 832 participants in the delayed monitoring group had 12 months of follow-up dataParticipantsCOUNT_OF_PARTICIPANTS

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring GroupImmediate Monitoring53Participants
Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring GroupDelayed Monitoring12Participants
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched ControlsImmediate Monitoring63Participants
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched ControlsDelayed Monitoring46Participants
Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched ControlsMatched Controls81Participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDImmediate Monitoring1,366
Overall StudySTARTEDDelayed Monitoring1,293
Overall StudySTARTEDMatch Controls3,476
Overall StudyCOMPLETEDImmediate Monitoring908
Overall StudyCOMPLETEDDelayed Monitoring834
Overall StudyCOMPLETEDMatch Controls3,476
Overall StudyNOT COMPLETEDImmediate Monitoring458
Overall StudyNOT COMPLETEDDelayed Monitoring459
Overall StudyNOT COMPLETEDMatch Controls0

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherSkin irritation from Zio XT patchSkin and subcutaneous tissue disordersImmediate Monitoring2090820
otherSkin irritation from Zio XT patchSkin and subcutaneous tissue disordersDelayed Monitoring2183421
otherSkin irritation from Amigo wristbandSkin and subcutaneous tissue disordersImmediate Monitoring02300
otherSkin irritation from Amigo wristbandSkin and subcutaneous tissue disordersDelayed Monitoring02300

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityImmediate Monitoring00
Total, all-cause mortalityDelayed Monitoring00
Total, other adverse eventsImmediate Monitoring20908
Total, other adverse eventsDelayed Monitoring21834
Total, serious adverse eventsImmediate Monitoring00
Total, serious adverse eventsDelayed Monitoring00

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
29998336DERIVEDPubMed
30656241DERIVEDPubMed
34610049DERIVEDPubMed
37905421DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Immediate Monitoring vs Delayed Monitoring: Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02506244

GET https://conductscience.org/api/trials/v1/NCT02506244/registered