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

Not Applicable

Completed

• Conditions: Post Acute COVID-19 Syndrome
• Interventions: Behavioral: Adhera® Fatigue for Long COVID program

• Registration Number: NCT05483829
• Lead Sponsor: Adhera Health, Inc.

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-29
• Study Start: 2022-08-01
• Study First Posted: 2022-08-02
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long COVID prospective group	Adhera® Fatigue for Long COVID program	-

Primary Outcome Measures

Name	Time	Method
Behavioral outcome: Usability	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.

Trial Locations

Locations (1)

Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut; 🇪🇸 Sant Fruitós De Bages, Catalonia, Spain