Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients Affected by Fatigue (AIDA)

NCT05483829 | Completed

• 1 other identifier: FAT-22-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients.

Conditions

Post Acute COVID-19 Syndrome

Keywords

Long COVID; mhealth; digital health; emotional health; behavioral intervention; mental wellbeing; mood disturbance; emotional adjustment

Outcome Measures

Primary Outcomes (1)

• Behavioral outcome: Usability

  mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.

  At week 4

Study Arms (1)

Long COVID prospective group

EXPERIMENTAL

Behavioral: Adhera® Fatigue for Long COVID program

Interventions

Adhera® Fatigue for Long COVID program BEHAVIORAL

Adhera® for the Long COVID program, which includes an application and a smartwatch, supported by digital health solution based on emotional and behavioral change techniques. Patient Adaptative Self-Management Content (e.g. psycho-educational content, activities for mental wellbeing, personalized motivational messages), and the personalization is based on Adhera® Health Recommender System. Wearable devices and the mobile app will be used to collect real-time data for 4 weeks to detect biometric and psychometric (patient-reported outcomes) information.

Long COVID prospective group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legal adults (older than 18)
• Long COVID diagnosis within the last year
• In possession of a compatible smartphone (Android OS v4.4 or higher)
• Reporting any of these symptoms:
• Fatigue
• Dyspnea
• Anxiety
• Stress
• Depression
• Sleep disorder

You may not qualify if:

• 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)

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator

Study Sites (1)

Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut

Sant Fruitós de Bages, Catalonia, 08272, Spain

Location

Related Links

• Withings Scanwatch wearable

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Josep Vidal-Alaball, MD, PhD

  Institut Universitari per a la recerca a l'Atencio Primaria de Salut Jordi Gol i Gurina (IDIAPJGol)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 2, 2022
• Study Start: August 1, 2022
• Primary Completion: August 28, 2022
• Study Completion: August 28, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)