Comparing a mobile ECG device with Holter monitoring for the diagnosis of arrhythmias in patients with palpitations
The purpose of this study is to compare the efficacy of the Kardia Mobile device platform with 24-hour Holter monitoring in diagnosing arrhythmias in patients who present to urgent care centers with palpitations.
Potential participants will be all patients above the age of 18 who present to SAUC facility in Tucson, Arizona, USA with palpitations in February 2017 through February 2018. Patients with unstable angina, syncope, or a known history of sustained VT/VF will be excluded from participation. The study will be capped at 100 participants. Patients will range in age from anything greater than 18 years old, will likely be an equal mix of male and female, and will be in varying states of health based upon their medical history. Patients selected to be enrolled must have a high enough index of suspicion for having cardiac disease based upon the individual provider’s discretion. Participation in the study is entirely voluntary; this will be made clear to potential participants and therefore none of the participants are likely to be vulnerable to coercion or undue influence. No special classes of participants will be included in the study. Human subject involvement will begin on July 1st, 2017 and end on July 1st, 2018.
If the patient complains of or acknowledges the presence of heart palpitations during his/her visit, the provider will say the following:
Provider: We are going to need to perform additional testing to determine the cause of your palpitations. I would like to refer you to a cardiologist for further testing. Also, we are performing a study to compare a mobile phone based device for recording ECG’s with Holter Monitors to determine if they are as effective in diagnosing individuals with palpitations. For the purposes of this study, we will provide you with both devices to help monitor your symptoms. Your participation in this study is completely voluntary, are you willing to participate?
If the patient agrees to participate, he/she will be provided with the Kardia Mobile device and trained on its proper use.
If the patient verbally agrees to participate, he/she will be provided with the Informed Consent Document. Potential participants will be guided through the documents by the provider and will have the opportunity to ask questions and seek clarification.
The privacy and confidentiality of participants is of utmost concern to the investigators of this study and will be maintained strictly at all times. Study participants’ medical information will not be shared with anyone outside of the data. All data and variables with conform with HIPAA de-identified data.
All research will be conducted within the Southern Arizona Urgent Care (SAUC) building and by SAUC staff. SAUC employees who will inform patients of their ability to participate in the research study will be trained in the protocols described in this document. Any and all support services are available on site.
The following will be used to protect the privacy of participants:
- All study data will be kept on password protected SAUC owned computing devices and in locked cabinets. This procedure will be highly effective in preventing unauthorized attempts at accessing study data.
- All electronic study data will be kept on encrypted HIPAA compliant secure networks. This procedure will be highly effective in preventing unauthorized attempts at accessing study data.
- All electronic EKG data will be accessed directly via the Kardia Mobile website on a secure wireless internet network. This procedure will be highly effective in preventing unauthorized attempts at accessing study data.
- Only the investigators listed above will have access to the data. This procedure will be highly effective in preventing unauthorized attempts at accessing study data.
Patients who participate in the study will be provided with the Kardia Mobile device and will be able to purchase the device at a discounted price at the end of the study. Potential benefits to society may result if Kardia Mobile is found to be non-inferior or superior to Holter Monitoring. Given the ease of use and low cost of Kardia Mobile, the overall diagnostic yield of AEM could improve as a result of widespread uptake of Kardia Mobile.