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AzTrials

Mental Health Wellness 1NCT06131463

Anxiety Associated With the Use of the Electrocardiogram Function in Smart Watches

A study testing Electrocardiogram (ECG) feature in smart watches in people with Mental Health Wellness 1 and Anxiety Disorders, run by ITMO University at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 22 to 100 yearsHealthy volunteers can take part
What is being tested?
Electrocardiogram (ECG) feature in smart watches
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteRussia
Study dates
13 Nov 2023to 4 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Status of a student or employee of ITMO University;
  • Availability of a smart watch with ECG function (Apple Watch Series 4 and newer, Galaxy Watch Active2, Samsung Galaxy Watch Series 3 and newer or similar with ECG function);
  • Availability of a Galaxy smartphone running Android 7.0 or newer or availability of an iPhone 8 and newer smartphone with the latest version of iOS.
  • Signed Informed consent and Consent for Data Processing of Personal Data;
  • Absence of previously diagnosed clinically significant cardiovascular pathology.

Who cannot join

  • Participants under the age of 22 cannot be included in the study;
  • Participants in the acute phase of any disease or in the exacerbation of chronic diseases are excluded from the study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • ITMO University

    Saint Petersburg, 197101

Other trials in Russia

About this study

Official title: Assessing the Impact of Using the Electrocardiogram Function in Smart Watches on the Level of Anxiety (GAD-7) Among University Students and Employees

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.

Read more

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.

Being tested
Electrocardiogram (ECG) feature in smart watches
Keywords
Anxiety, Depression, ECG, Smartwatch, Randomized trial
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrocardiogram (ECG) feature in smart watchesDevice

    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.

Study groups in NCT06131463
Study groupRoleWhat they receive
ECG function is enabledExperimentalElectrocardiogram (ECG) feature on the smartwatch is enabled
Receives: Device: Electrocardiogram (ECG) feature in smart watches
ECG function is not enabledNo interventionElectrocardiogram (ECG) feature on the smartwatch is not enabled

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

Secondary outcomes (4)

  1. 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).

    Measured: 30 days

  2. Depression

    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).

    Measured: 90 days

  3. 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.

    Measured: 90 days

  4. Heart rhythm disturbances

    The frequency of detection of clinically significant and clinically insignificant heart rhythm disturbances.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion16 Jan 2024
  4. Study completion4 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131463
Sponsor's protocol ID
be-healthy-smart-watches
Status last verified
Apr 2024
First submitted
9 Nov 2023
Last updated
4 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29562087

  • 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.

    PubMed 30700139

  • 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.

    PubMed 35076659

  • 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.

    PubMed 34386784

  • 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.

    PubMed 18388841

  • 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.

    PubMed 11556941

  • 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.

    PubMed 32090765

Questions about this trial

What is this clinical trial studying?

A study testing Electrocardiogram (ECG) feature in smart watches in people with Mental Health Wellness 1 and Anxiety Disorders, run by ITMO University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety level (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131463, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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