SENSING-AI Cohort for Long COVID Patients (SENSING-AI)

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.

Study Overview

• Status: Completed
• Conditions: Post-acute COVID-19 Syndrome
• Intervention / Treatment: Other: Collection of clinical, psychometric and biometric data

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08007
    • IDIAP Jordi Gol
  • Seville, Spain, 41927
    • Primary Care Aljarafe-Sevilla Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Long COVID cases; The target population will be 10 patients diagnosed during 2021 with long COVID, who will then be followed-up for one month.	Other: Collection of clinical, psychometric and biometric data; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
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.	1 month
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.	1 month
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.	1 month
Physical Activity Bpm	Through the Withings Scanwatch the following physical activity data are gathered: Daily minimum/average/maximum heart rate in bpm.	1 month
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.	1 month
Physical Activity Oxygen Saturation	Through the Withings Scanwatch the following physical activity data are gathered: Manual Oxygen Saturation (SpO2) measurements.	1 month
Workouts Kcal	Through the Withings Scanwatch the following workouts data are gathered: Calories / workout events in Kcal.	1 month
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.	1 month
Workouts Bpm	Through the Withings Scanwatch the following workouts data are gathered: Heart rate/minimum/average/maximum intensity in bpm.	1 month
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.	1 month
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.	1 month
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.	1 month
Sleep quality Rapid Eye Movement	Through the Withings Scanwatch the following sleep quality data are gathered: Rapid Eye Movement (REM) sleep phase count.	1 month
Sleep quality Bpm	Through the Withings Scanwatch the following sleep quality data are gathered: Average heart rate in bpm; Average minimum bpm rate.	1 month
Sleep quality Breathing	Through the Withings Scanwatch the following sleep quality data are gathered: Intensity of breathing disturbances.	1 month
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.	Weekly up to 1 month
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.	Weekly up to 1 month
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.	Weekly up to 1 month
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.	Weekly up to 1 month
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.	Weekly up to 1 month
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.	Weekly up to 1 month

Collaborators and Investigators

• Sponsor: Adhera Health, Inc.
• Collaborators: Jordi Gol i Gurina Foundation; Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Withings Scanwatch

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): February 12, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Mental Health; Artificial Intelligence; Prospective study; COVID-19 syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SEN-0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No