MedTrace Logo

Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue

NCT05631171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-07-20

No results posted yet for this study

Summary

Adhera® Fatigue Digital Program (or AFDP) is a digital health program based on behavioral and emotional change techniques that provides personalized physical and emotional self-management support for patients with long COVID-related fatigue.

The digital health solution is designed to be used for 3 months, and includes a mobile application and a smartwatch. This is a clinical study, with 30 participants in the experimental intervention group and 30 in the control group, that will be carried out at the Jordi Gol Primary Care Research Institute (IDIAPJGol) - Institut Català de la Salut and Distrito sanitario Aljarafe-Sevilla Norte (DASN) - Servicio Andaluz de Salud, in Spain. The investigators will focus on evaluating the feasibility of the program in supporting fatigue and also physical and emotional self-management and, consequently, in improving the patients' well-being and quality of life.

Conditions

  • Post-Acute COVID19 Syndrome
  • Fatigue

Interventions

BEHAVIORAL

Adhera® Fatigue Digital Program

Adhera® Fatigue Digital Program, that includes an application and a smartwatch, is a 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 3 months to detect biometric and psychometric (patient-reported outcomes) information.

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER

  • Andaluz Health Service

    collaborator OTHER_GOV

  • Adhera Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631171 on ClinicalTrials.gov