An observational study in Post-acute COVID-19 Syndrome, sponsored by Adhera Health, Inc.. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Adhera Health, Inc. · Observational
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.
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.
536 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 187 are open to participants now.
This study's enrollment of 10 is below the median of 160 across 149 observational studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Adhera Health, Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Sample will be recruited from patients attending Primary Care Aljarafe-Sevilla Norte centers and Jordi Gol Primary Care Research Institute.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Physical Activity Bpm
Through the Withings Scanwatch the following physical activity data are gathered: Daily minimum/average/maximum heart rate in bpm.
Time frame: 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.
Time frame: 1 month
Physical Activity Oxygen Saturation
Through the Withings Scanwatch the following physical activity data are gathered: Manual Oxygen Saturation (SpO2) measurements.
Time frame: 1 month
Workouts Kcal
Through the Withings Scanwatch the following workouts data are gathered: Calories / workout events in Kcal.
Time frame: 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.
Time frame: 1 month
Workouts Bpm
Through the Withings Scanwatch the following workouts data are gathered: Heart rate/minimum/average/maximum intensity in bpm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month
Sleep quality Breathing
Through the Withings Scanwatch the following sleep quality data are gathered: Intensity of breathing disturbances.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly up to 1 month
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Post-Acute COVID-19 Syndrome →
Adhera Health, Inc.