N/A
Completed N=120
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Source: ClinicalTrials.gov NCT03761394 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
Nov 2023
Primary outcomePrimary: Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization — 31 Participants
Summary
The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization |
31 | — |
| PRIMARY The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period |
7 | — |
| PRIMARY The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization. |
6; 0 | — |
| SECONDARY Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization. |
0.17; -0.77; 0.56; -0.46 | — |
| SECONDARY Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days) |
1.56; 3.10; 2.90; 1.08 | — |
| SECONDARY Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days) |
0.35; 0.27; -0.04; 0.36 | — |
| SECONDARY Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization |
0.67; -9.03 | — |
| SECONDARY Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization |
1.52; 0.74 | — |
| SECONDARY Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days) |
3.75; 2.00; 4.29; 1.54 | — |
| SECONDARY Change in Medication Adherence at Baseline and 14 Days Post the First Randomization |
-1.12 | — |
Eligibility Criteria
Inclusion Criteria
- History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
- Age: greater to or equal to 50 years of age
- Able to sign informed consent
- Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
- Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only
Exclusion Criteria
- Major contraindication to anti-coagulation treatment
- Plans to move our of the area over the 44-day follow up period
- Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
- Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
- Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
- Patient with implantable pacemaker as paced beats interfere with ECG readings
- Lacking capacity to sign informed consent
- Unable to read and write in English
- Plans to move from the area during the study period
- Unwilling to complete all study procedures
- Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
- Individuals who are not yet adults
- Pregnant women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT03761394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.