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

September 21, 2022 updated by: Adhera Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Sant Fruitós De Bages, Catalonia, Spain, 08272
        • Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long COVID prospective group
Behavioral: Adhera® Fatigue for Long COVID program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adhera Health, Inc.

Collaborators

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

Investigators

  • Principal Investigator: Josep Vidal-Alaball, MD, PhD, Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

August 28, 2022

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 29, 2022

First Posted (Actual)

August 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAT-22-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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