Clinical trial NCT03761394: Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Official title: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Atrial Fibrillation
Keywords: Cardiac Arrhythmias
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: Northeastern University
name: Brigham and Women's Hospital
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-12-03
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.


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

Primary outcomes:
measure: Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization
timeFrame: Assessed 14 days post the first randomization
measure: The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period
timeFrame: Assessed throughout 14 day trial period
measure: The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.
timeFrame: Assessed at 14 days post the first randomization.
Secondary outcomes:
measure: Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.
timeFrame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
measure: Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
timeFrame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
measure: Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
timeFrame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
measure: Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization
timeFrame: Assessed at baseline and 14 days post the first randomization
measure: Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization
timeFrame: Assessed at baseline and 14 days post randomization
measure: Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
timeFrame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
measure: Change in Medication Adherence at Baseline and 14 Days Post the First Randomization
timeFrame: Assessed at baseline and 14 days post the first randomization
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Timothy Fitzgibbons, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: