SENSING-AI Cohort for Long COVID Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Post-acute COVID-19 Syndrome

Intervention / Treatment
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* Other: Collection of clinical, psychometric and biometric data


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Long COVID cases<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 syndrome, Prospective study, Artificial Intelligence, Mental Health