Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke

NCT03761394 | Completed Results DMC FDA Device

• 2 other identifiers: H00016067R01HL137734-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Atrial Fibrillation

Keywords

Cardiac Arrhythmias

Outcome Measures

Primary Outcomes (3)

• Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization

  System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application. Number of participants with SUS \> 68 was reported in the Outcome Measure Data Table

  Assessed 14 days post the first randomization

• The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period

  This outcome was measured by the number of atrial fibrillation episodes identified by the smartwatch biosensors. This was conducted using two approaches. Firstly, the Pulsewatch app sent a message to participants to remain still and perform a 30-sec ECG self-check (wrist electrode, high accuracy) should they have an AF episode detected. The second approach involved the cancellation of cyclical frequencies, seen in accelerometer data, from the photoplethysmogram (PPG) signal. Thus, these two approaches were effectively used to recover some data segments contaminated by MNA or by poor signal quality and correctly identified the presence or absence of AF. Once MN artifacts were corrected, we looked at patterns to analyze pulse waveforms for AF detection, including discrimination of PVCs and PACs

  Assessed throughout 14 day trial period

• The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.

  Episodes of atrial fibrillation was identified by the gold-standard monitor (Cardea Solo by Cardiac Insight). The Cardiac Insight patches have a module chip inside the sensor that stores the data being collected over the 14-days. After the participants returned the patches at the end of the 14-day monitoring period, a trained study staff removed the modules and placed them into the Cardiac insight smart cable to be uploaded to a UMass Medical School server. The ECG readings are then read by a board-certified cardiologist to confirm true atrial fibrillation detection.

  Assessed at 14 days post the first randomization.

Secondary Outcomes (7)

• Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.

  Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)

• Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)

  Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)

• Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)

  Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)

• Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization

  Assessed at baseline and 14 days post the first randomization

• Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization

  Assessed at baseline and 14 days post randomization

Study Arms (4)

Intervention Group

EXPERIMENTAL

Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period.

Device: Testing Devices; Device: Cardea Solo by Cardiac Insight

Control Group

ACTIVE COMPARATOR

Only Cardea Solo device by Cardiac Insight for 14-day period.

Device: Cardea Solo by Cardiac Insight

Intervention Group for Extended Use

EXPERIMENTAL

30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor.

Device: Testing Devices; Device: Kardia Mobile by AliveCor

Control Group for Extended Use

NO INTERVENTION

No device usage for 30-days following completion of the original 14-day period.

Interventions

Testing Devices DEVICE

Pulsewatch system testing application on smartphone with smartwatch.

Intervention Group; Intervention Group for Extended Use

Cardea Solo by Cardiac Insight DEVICE

Gold-standard cardiac monitor for comparison of testing devices.

Control Group; Intervention Group

Kardia Mobile by AliveCor DEVICE

Mobile ECG device for comparison of testing devices during the extended use period.

Intervention Group for Extended Use

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• University of Connecticut: collaborator
• Northeastern University: collaborator
• Brigham and Women's Hospital: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

• Ding EY, Tran KV, Lessard D, Wang Z, Han D, Mohagheghian F, Mensah Otabil E, Noorishirazi K, Mehawej J, Filippaios A, Naeem S, Gottbrecht MF, Fitzgibbons TP, Saczynski JS, Barton B, Chon K, McManus DD. Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial. JMIR Cardio. 2023 Nov 28;7:e45137. doi: 10.2196/45137.

  PMID: 38015598 DERIVED

• Han D, Ding EY, Cho C, Jung H, Dickson EL, Mohagheghian F, Peitzsch AG, DiMezza D, Tran KV, McManus DD, Chon KH. A Smartwatch System for Continuous Monitoring of Atrial Fibrillation in Older Adults After Stroke or Transient Ischemic Attack: Application Design Study. JMIR Cardio. 2023 Feb 13;7:e41691. doi: 10.2196/41691.

  PMID: 36780211 DERIVED

MeSH Terms

Conditions

Stroke; Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Edith Mensah Otabil
• Organization: UMass Chan Medical School

edith.mensahotabil@umassmed.edu

774-455-6574

Study Officials

• Timothy Fitzgibbons, MD, PhD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: September 3, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)