Clinical trial NCT05204615: SENSING-AI Cohort for Long COVID Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-acute COVID-19 Syndrome
Keywords: COVID-19 syndrome
Prospective study
Artificial Intelligence
Mental Health
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
First posted: 2022-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical Activity Distances
timeFrame: 1 month
measure: Physical Activity in Steps
timeFrame: 1 month
measure: Physical Activity Duration
timeFrame: 1 month
measure: Physical Activity Kcal
timeFrame: 1 month
measure: Physical Activity Bpm
timeFrame: 1 month
measure: Physical Activity Heart Rate
timeFrame: 1 month
measure: Physical Activity Oxygen Saturation
timeFrame: 1 month
measure: Workouts Kcal
timeFrame: 1 month
measure: Workouts distances
timeFrame: 1 month
measure: Workouts Bpm
timeFrame: 1 month
measure: Workouts Heart Rate
timeFrame: 1 month
measure: Sleep quality Number of Times Awake
timeFrame: 1 month
measure: Sleep quality duration
timeFrame: 1 month
measure: Sleep quality Rapid Eye Movement
timeFrame: 1 month
measure: Sleep quality Bpm
timeFrame: 1 month
measure: Sleep quality Breathing
timeFrame: 1 month
measure: Fatigue Assessment Scale
timeFrame: Weekly up to 1 month
measure: Dyspnoea Index
timeFrame: Weekly up to 1 month
measure: Generalized Anxiety Disorder 7-Item Scale
timeFrame: Weekly up to 1 month
measure: Perceived Stress Scale
timeFrame: Weekly up to 1 month
measure: Patient Health Questionnaire-9
timeFrame: Weekly up to 1 month
measure: Oviedo Sleep Questionnaire
timeFrame: Weekly up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IDIAP Jordi Gol
city: Seville
country: Spain
facility: Primary Care Aljarafe-Sevilla Norte
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.