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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | End 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) |
| Secondary | Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 1 year | In the observational study, over 12 months of follow-up, we looked at the prevalence of AF in the actively monitored and delayed monitored cohorts. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | End of 4 month monitoring period | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | 1 year | 906 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 data | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | Immediate Monitoring | 53 | Participants | ||
| Incidence of Newly Diagnosed AF in the Immediate vs Delayed Monitoring Group | Delayed Monitoring | 12 | Participants | ||
| Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | Immediate Monitoring | 63 | Participants | ||
| Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | Delayed Monitoring | 46 | Participants | ||
| Prevalence of Atrial Fibrillation in Both Monitoring Groups Versus the Matched Controls | Matched Controls | 81 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Immediate Monitoring | 1,366 | |
| Overall Study | STARTED | Delayed Monitoring | 1,293 | |
| Overall Study | STARTED | Match Controls | 3,476 | |
| Overall Study | COMPLETED | Immediate Monitoring | 908 | |
| Overall Study | COMPLETED | Delayed Monitoring | 834 | |
| Overall Study | COMPLETED | Match Controls | 3,476 | |
| Overall Study | NOT COMPLETED | Immediate Monitoring | 458 | |
| Overall Study | NOT COMPLETED | Delayed Monitoring | 459 | |
| Overall Study | NOT COMPLETED | Match Controls | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin irritation from Zio XT patch | Skin and subcutaneous tissue disorders | Immediate Monitoring | 20 | 908 | 20 |
| other | Skin irritation from Zio XT patch | Skin and subcutaneous tissue disorders | Delayed Monitoring | 21 | 834 | 21 |
| other | Skin irritation from Amigo wristband | Skin and subcutaneous tissue disorders | Immediate Monitoring | 0 | 230 | 0 |
| other | Skin irritation from Amigo wristband | Skin and subcutaneous tissue disorders | Delayed Monitoring | 0 | 230 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Immediate Monitoring | 0 | 0 |
| Total, all-cause mortality | Delayed Monitoring | 0 | 0 |
| Total, other adverse events | Immediate Monitoring | 20 | 908 |
| Total, other adverse events | Delayed Monitoring | 21 | 834 |
| Total, serious adverse events | Immediate Monitoring | 0 | 0 |
| Total, serious adverse events | Delayed Monitoring | 0 | 0 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
Source Trial comparisons
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.
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