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The integration of electrocardiography (ECG) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. However, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups.
Some smart device manufacturers do not recommend using the ECG function for anyone under the age of 22. However, young people are frequent users of wearable devices. One of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal.
That said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety.
This study will assess the level of psycho-emotional health (anxiety level) of the study participants. Participant observation will provide an opportunity to identify associations between the use of the ECG recording function on wearable devices and levels of anxiety and depression. It is hypothesized that the use of smartwatches with the ECG function activated will not lead to a change in anxiety levels on the GAD-7 scale among the study participants. This assumes that after 30 days of use, the mean value of the GAD-7 scale in the intervention group and the control group will be the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG function is enabled | Experimental | Electrocardiogram (ECG) feature on the smartwatch is enabled |
|
| ECG function is not enabled | No Intervention | Electrocardiogram (ECG) feature on the smartwatch is not enabled |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram (ECG) feature in smart watches | Device | A study participant that is randomly assigned to the experimental group should enable the ECG function on his or her smart watch and make sure that there is synchronization with a corresponding application on his or her mobile phone. The ECG function must stay enabled, and the participant should wear the smartwatch every day for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | Anxiety level is measured 30 days after the enrolment with Generalized Anxiety Disorder 7-item (GAD-7) which is a tool based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Depression is assessed 30 days after the enrolment with Patient Health Questionnaire-9 (PHQ-9) that can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). | 30 days |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liubov Maliugina, MD | ITMO University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ITMO University | Saint Petersburg | 197101 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29562087 | Background | Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136. | |
| 30700139 | Background |
| Label | URL |
|---|---|
| How to use the ECG app on Apple Devices | View source |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Depression is assessed 90 days after the enrolment with Patient Health Questionnaire-9 (PHQ-9) that can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).
| 90 days |
| Anxiety level | Anxiety level is measured 90 days after the enrolment with Generalized Anxiety Disorder 7-item (GAD-7) which is a tool based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively. | 90 days |
| Heart rhythm disturbances | The frequency of detection of clinically significant and clinically insignificant heart rhythm disturbances. | 90 days |
| Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available. |
| 35076659 | Background | US Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Epling JW Jr, Kubik M, Li L, Ogedegbe G, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement. JAMA. 2022 Jan 25;327(4):360-367. doi: 10.1001/jama.2021.23732. |
| 34386784 | Background | Rosman L, Gehi A, Lampert R. When smartwatches contribute to health anxiety in patients with atrial fibrillation. Cardiovasc Digit Health J. 2020 Jul-Aug;1(1):9-10. doi: 10.1016/j.cvdhj.2020.06.004. Epub 2020 Aug 28. No abstract available. |
| 18388841 | Background | Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093. |
| 11556941 | Background | Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. |
| 32090765 | Background | Toussaint A, Husing P, Gumz A, Wingenfeld K, Harter M, Schramm E, Lowe B. Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020 Mar 15;265:395-401. doi: 10.1016/j.jad.2020.01.032. Epub 2020 Jan 15. |
| D004568 | Electrodiagnosis |