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Enrolling By Invitation
NCT05631171
Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
Conditions: Post-Acute COVID19 Syndrome, Fatigue
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Adhera Health, Inc.
Location: Spain
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.
Eligibility Criteria
Inclusion Criteria:Individuals over 18 years of age.With long COVID, according to the World Health Organization (WHO) consensus definitionHaving a history of fatigue symptomsObtain a score between 4 and 10 on the question "By how much do you rate your fatigue level from 0 to 10 in the last 7 days?",
where 0 is no fatigue and 10 is the worst fatigue imaginableHave an Android or iOS smartphone compatible with the intervention program.Agree to participate in the study and sign the informed consent formWillingness and availability to comply with all study guidelines and proceduresExclusion Criteria:Hospital admission during the period of study participation.Participation in another study with pharmacological treatmentPatients who are not technologically literate or unable to use the mobile application.Known severe psychiatric illness or presence of relevant cognitive impairment, at the discretion of the recruiting physicianWith mobility restrictions that limit the patient's ability to perform mild physical activityBeing pregnantPatients who do not understand or speak Catalan or Spanish.
Source: ClinicalTrials.gov (NCT05631171). StuddyBuddy aggregates publicly available trial information.