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Post-acute COVID-19 SyndromeSENSING-AINCT05204615

SENSING-AI Cohort for Long COVID Patients

An observational study of Post-acute COVID-19 Syndrome, run by Adhera Health, Inc. at 2 sites in Spain.

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 prospective study will focus on the collection of biometric and psychometric data from a limited population for 1 month with the aim of complementing the SENSING-AI retrospective cohort. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-acute COVID-19 Syndrome
What is being tested?
Collection of clinical, psychometric and biometric data
How many people
10 participants
Where
2 sitesSpain
Study dates
18 Jan 2022to 28 Apr 2022
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Sample will be recruited from patients attending Primary Care Aljarafe-Sevilla Norte centers and Jordi Gol Primary Care Research Institute.

Who may be able to join

  • Legal adults
  • With a long COVID-19 diagnose in the last year
  • Reporting any of these symptoms:
  • Fatigue
  • Dyspnea
  • Shortness of breath
Show all 11Show fewer
  • Anxiety
  • Stress
  • Depression
  • Conduct disorder
  • Sleep disorder

Who cannot join

  • Hospital admission during follow-up due to pathology not related to COVID-19
  • Patients without digital literacy or who cannot use the mobile application.
  • Known severe psychiatric illness or cognitive impairment
  • Being pregnant (or suspected to be pregnant)
  • Discharged after hospital admission due to COVID-19

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • IDIAP Jordi Gol

    Barcelona, 08007

  • Primary Care Aljarafe-Sevilla Norte

    Seville, 41927

Other trials in Spain

About this study

Official title: Prospective Data Collection for SENSING-AI: A Precision Digital and Wearables Platform for the Early Diagnosis of Emotional and Physical Complications in Patients With Long COVID Through the Use of Artificial Intelligence

The prospective study will focus on the collection of biometric and psychometric data from a limited population for 1 month with the aim of complementing the SENSING-AI retrospective cohort.

Read the detailed description

The stratification of the risk of complications related to persistent COVID symptoms both physiological and psychological in a personalized way would optimize the cost-effectiveness model for the management of these patients. Similarly, the early detection of complications associated with persistent COVID in patients belonging to vulnerable groups would improve care times and, therefore, the patient's prognosis.

The primary objective of this study is to complement the SENSING-AI cohort with biometric and psychometric data prospectively gathered from patients diagnosed with long COVID in the last year to drive the generation of AI-based risk prediction and stratification models.

Being tested
Collection of clinical, psychometric and biometric data
Keywords
COVID-19 syndrome, Prospective study, Artificial Intelligence, Mental Health
Medical subject headings
Post-Acute COVID-19 Syndrome, Psychological Well-Being

What participants receive

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

  • Collection of clinical, psychometric and biometric dataOther

    Wearable devices and a mobile app will be used to collect real-time data for 4 weeks to detect physiological and psychological complications based on biometric and psychometric (patient-reported outcomes) information.

Study groups in NCT05204615
Study groupRoleWhat they receive
Prospective Long COVID casesThe target population will be 10 patients diagnosed during 2021 with long COVID, who will then be followed-up for one month.
Receives: Other: Collection of clinical, psychometric and biometric data

What is being measured

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

  1. Physical Activity Distances

    Through the Withings Scanwatch the following physical activity data are gathered: Daily distance travelled in metres; List of distance travelled/ 4-5 minutes approx.; Daily number of floors climbed in metres; List of distance travelled/ approx. 4-5 minutes.

    Measured: 1 month

  2. Physical Activity in Steps

    Through the Withings Scanwatch the following physical activity data are gathered: Daily number of steps; List of steps/ 4-5 minutes approximately.

    Measured: 1 month

  3. Physical Activity Duration

    Through the Withings Scanwatch the following physical activity data are gathered: Daily duration of light, moderate and intense intensity activities in seconds; Daily sum of moderate and intense activities in seconds.

    Measured: 1 month

  4. Physical Activity Kcal

    Through the Withings Scanwatch the following physical activity data are gathered: Daily active calories burned in Kcal; Total daily calories burned in Kcal; List of calories burned/ approx. 4-5 minutes.

    Measured: 1 month

  5. Physical Activity Bpm

    Through the Withings Scanwatch the following physical activity data are gathered: Daily minimum/average/maximum heart rate in bpm.

    Measured: 1 month

  6. Physical Activity Heart Rate

    Through the Withings Scanwatch the following physical activity data are gathered: Daily duration in seconds of heart rate; List of heart rate measurements/10 minutes/average rate.

    Measured: 1 month

  7. Physical Activity Oxygen Saturation

    Through the Withings Scanwatch the following physical activity data are gathered: Manual Oxygen Saturation (SpO2) measurements.

    Measured: 1 month

  8. Workouts Kcal

    Through the Withings Scanwatch the following workouts data are gathered: Calories / workout events in Kcal.

    Measured: 1 month

  9. Workouts distances

    Through the Withings Scanwatch the following workouts data are gathered: Distance of the workouts in meters; Steps climbed in metres; Step run in meters.

    Measured: 1 month

  10. Workouts Bpm

    Through the Withings Scanwatch the following workouts data are gathered: Heart rate/minimum/average/maximum intensity in bpm.

    Measured: 1 month

  11. Workouts Heart Rate

    Through the Withings Scanwatch the following workouts data are gathered: Duration in the minimum/moderate/intense heart rate zone in seconds; Duration of maximum heart rate in seconds.

    Measured: 1 month

  12. Sleep quality Number of Times Awake

    Through the Withings Scanwatch the following sleep quality data are gathered: Number of times the user woke up; Number of times the user got out of bed during the night.

    Measured: 1 month

  13. Sleep quality duration

    Through the Withings Scanwatch the following sleep quality data are gathered: Total time spent in bed in seconds; Total time asleep in seconds; Time spent in bed before falling asleep in seconds; Time spent in bed after waking up in seconds; Time spent awake in bed after falling asleep for the first time during the night in seconds; Duration in light resting state in seconds; Duration in deep sleep state in seconds; Ratio of total sleep time/time spent in bed.

    Measured: 1 month

  14. Sleep quality Rapid Eye Movement

    Through the Withings Scanwatch the following sleep quality data are gathered: Rapid Eye Movement (REM) sleep phase count.

    Measured: 1 month

  15. Sleep quality Bpm

    Through the Withings Scanwatch the following sleep quality data are gathered: Average heart rate in bpm; Average minimum bpm rate.

    Measured: 1 month

  16. Sleep quality Breathing

    Through the Withings Scanwatch the following sleep quality data are gathered: Intensity of breathing disturbances.

    Measured: 1 month

  17. Fatigue Assessment Scale

    The Fatigue Assessment Scale is a unidimensional scale, consisting of 10-items measured on 5-point rating scale varies from 1 never to 5 always. Scores range from 10 to 50 with higher scores indicating greater fatigue.

    Measured: Weekly up to 1 month

  18. Dyspnoea Index

    Dyspnoea Index is a unidimensional scale, consisting of 10-items evaluated on a 0-4 Likert Scale (0= never; 1= almost never; 2= sometimes; 3= almost always; 4= always). Scores range from 0 to 40 and higher scores indicate greater dyspnea.

    Measured: Weekly up to 1 month

  19. Generalized Anxiety Disorder 7-Item Scale

    Generalized Anxiety Disorder 7-Item Scale consists of 7 items measured on 4-point rating scale varies from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21 with higher scores indicating higher anxiety levels.

    Measured: Weekly up to 1 month

  20. Perceived Stress Scale

    Perceived Stress Scale consists of 10 items measures on 4-point rating scale varies from 0 (never) to 4 (nearly every day). Scores range from 0 to 40 with higher scores indicating higher perceived stress.

    Measured: Weekly up to 1 month

  21. Patient Health Questionnaire-9

    Patient Health Questionnaire-9 consists of 9 items measures on 4-point rating scale varies from 0 (never) to 3 (nearly every day). Scores range from 0 to 27 and higher scores indicate higher depression levels.

    Measured: Weekly up to 1 month

  22. Oviedo Sleep Questionnaire

    Oviedo Sleep Questionnaire consists of 15 items, 13 form the scale itself and two are descriptive items to provide the clinician with information on parasomnias and on the type and frequency of use of any type of sleep aid. The 13 items are grouped in 3 subscales: a) Subjective satisfaction with sleep: 1 item. Likert scale of satisfaction with 7 values ranging from 1 (very dissatisfied) to 7 (very satisfied); b) Insomnia: made up of 9 items to assess the nature of insomnia (difficulties in reconciling sleep, maintenance, early awakening, non-restorative sleep) and its repercussions on wakefulness (worry/tiredness/decreased functioning. Scored on a 5-value Likert scale (from 1 to 5) where the higher the score, the greater the severity; c) Hypersomnia: consisting of 3 items that assess daytime sleepiness and concern/decreased functioning for this reason. Scored on a 5-value Likert scale (from 1 to 5) where the higher the score, the greater the severity.

    Measured: Weekly up to 1 month

Timeline

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

  1. First posted24 Jan 2022
  2. Study start18 Jan 2022
  3. Primary completion12 Feb 2022
  4. Study completion28 Apr 2022

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204615
Sponsor's protocol ID
SEN-0221
Acronym
SENSING-AI
Status last verified
Jan 2022
First submitted
10 Jan 2022
Last updated
5 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Michielsen HJ, De Vries J, Van Heck GL. Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale. J Psychosom Res. 2003 Apr;54(4):345-52. doi: 10.1016/s0022-3999(02)00392-6.

    PubMed 12670612

  • Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.

    PubMed 25311596

  • Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

    PubMed 16673626

  • Campo-Arias A, Pedrozo-Pupo JC, Cogollo-Milanes Z. [PHQ-9 in screening of major depressive episode among COVID-19 survivors]. Rev Colomb Psiquiatr (Engl Ed). 2021 Jul 2. doi: 10.1016/j.rcp.2021.06.004. Online ahead of print. No abstract available. Spanish.

    PubMed 34230698

  • Johnson SU, Ulvenes PG, Oktedalen T, Hoffart A. Psychometric Properties of the General Anxiety Disorder 7-Item (GAD-7) Scale in a Heterogeneous Psychiatric Sample. Front Psychol. 2019 Aug 6;10:1713. doi: 10.3389/fpsyg.2019.01713. eCollection 2019.

    PubMed 31447721

  • 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

  • Paz Garcia-Portilla M, Saiz PA, Diaz-Mesa EM, Fonseca E, Arrojo M, Sierra P, Sarramea F, Sanchez E, Goikole JM, Balanza V, Benabarre A, Bobes J. Psychometric performance of the Oviedo Sleep Questionnaire in patients with severe mental disorder. Rev Psiquiatr Salud Ment. 2009 Oct;2(4):169-77. doi: 10.1016/S1888-9891(09)73235-5. Epub 2010 Jan 25. English, Spanish.

    PubMed 23034346

  • Fuster-Casanovas A, Fernandez-Luque L, Nunez-Benjumea FJ, Moreno Conde A, Luque-Romero LG, Bilionis I, Rubio Escudero C, Chicchi Giglioli IA, Vidal-Alaball J. An Artificial Intelligence-Driven Digital Health Solution to Support Clinical Management of Patients With Long COVID-19: Protocol for a Prospective Multicenter Observational Study. JMIR Res Protoc. 2022 Oct 14;11(10):e37704. doi: 10.2196/37704.

    PubMed 36166648

Questions about this trial

What is this clinical trial studying?

An observational study of Post-acute COVID-19 Syndrome, run by Adhera Health, Inc. at 2 sites in Spain.

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 11 inclusion and 5 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Physical Activity Distances (time frame: 1 month). The study lists 22 primary outcomes in all. 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 NCT05204615, which also lists 8 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 5 Jan 2023.

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