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Questions Regarding Study Participation

Tell me more about the steps of participation in the Novel Exams Using Smart Technologies for Heart Health (NExUS) study?

If you join this study:

  1. Study staff will invite you via email to join our project by downloading an application on your smartphone.
  2. Once enrolled we will ask you to complete a survey through the app that will ask about medical history, medications, demographic information, your health, including personal health behaviors. The initial surveys should take about 30 minutes.
  3. We will deliver short surveys (5-10 minutes) via the downloaded smartphone application as often as every two weeks to follow up about your health behaviors.
  4. We will periodically review and collect information from your medical records up to 30 months (two and half years) after your enrollment.
  5. We will ask you to share health information collected by your commercial wearable device to the study app if you have one.
  6. You will also be entered in a raffle to win a small prize as described below.

What are the benefits and risks of participating in the study?

Benefits: Your participation will help us to gain knowledge that may help treat patients with AF or other chronic conditions.

Risks:  We will take steps to protect your personal information. However, there is a risk of breach of confidentiality. Other possible risks from participating in this study are anxiety and inconvenience from answering some of the study questions. If you feel uncomfortable and do not want to continue with the study, you may stop at any time or you may decline to answer any specific question.

How many people will take part in this research study?

About 1000 people will take part here at UMass Chan Medical School.

Why should I participate?

Your participation will help us understand the medical, environmental, and psychosocial factors that may influence the onset and progression of chronic medical conditions like atrial fibrillation.

Who is eligible to participate?

Participants will be selected based on preset inclusion criteria and will not be considered should they meet even one exclusion criteria as below:

Inclusion Criteria:

  1. Receives care from the UMass Chan cardiology or internal medicine clinics and/or services
  2. Has an email address on record in the EHR
  3. Has a diagnosis of AF or is at high risk of developing AF (CHADS-VASC stroke risk score >2)
  4. For phase II, participants will only be included if they participated in phase I and agreed to be contacted about future research.

Exclusion Criteria:

  1. Non-English-speaking
  2. Unable to provide informed consent
  3. Incarcerated patients
  4. Patients under the age of 18

How do you plan to contact the eligible participants?

Eligible patients will be contacted via email for participation in a survey-based study regarding their views on using wearable technologies for health monitoring. This email will contain a link to a Fact Sheet about the study and a HIPAA authorization, followed by the survey.

How long will the study last?

This study consists of two major phases and will last for about two and a half years.

Phase I – Initial survey: Phase 1 will consist of one survey that will be completed online.

Phase II – Longitudinal follow-up:  Phase 2 will consist of a two-and-a-half-year period of follow-up with intermittent surveys that participants will complete via an app and periodic collection of medical record data to look for any changes in participants’ health.

What is the timeline for receiving the surveys after enrollment?

Phase 1: There will only be one survey that will be completed right after enrolling.

Phase 2: Surveys will be administered to participants at the following time points: enrollment, 6 months, 12 months, 18 months, and 24 months from their time of enrollment. Data from their wearable devices (if they own one) will be actively collected through this time period.