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NCT Number: NCT05483829

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sant Fruitós de Bages, Catalonia, 08272, Spain

About this study

The study will explore the usability and engagement of a digital program designed for long covid patients affected by fatigue. The digital program relies on the Adhera® personalized digital health solution that includes personalized patient education and support, monitoring using psychometrics and wearables, and mental wellbeing exercises. The patients access the mobile solution via a mobile app. A total of 15 patients will be recruited and use the mobile solution for one month.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

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.

Primary outcomes

  1. Behavioral outcome: Usability

    Time frame: At week 4

    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.

Sponsors and collaborators

Lead sponsor

Adhera Health, Inc.

Industry

Collaborators

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Registry information

Official study title

AIDA - A Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients: Feasibility Study.

Acronym: AIDA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2022
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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