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

Adhera Health

Status: Completed

Conditions: Fatigue; Post-Acute COVID19 Syndrome

Treatments: Behavioral: Adhera® Fatigue Digital Program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05631171

FAT-22-002

Details and patient eligibility

About

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.

Full description

The COVIDAI study will collect data on symptomatology and emotional well-being in a population of patients with fatigue related to a diagnosis of long COVID for 3 months using or not using the Adhera® Fatigue Digital Program (30 participants in the experimental intervention group and 30 in the control group). The aim of the study is to evaluate the feasibility of the program in supporting physical and emotional self-management in long COVID patients with fatigue and, consequently, in improving the patients' quality of life.

Personalized digital health solutions for both physiological and psychological long COVID-related symptoms would allow an optimization of the cost-effectiveness model for the management of long COVID patients. Similarly, the early detection of complications associated to long COVID on patients from vulnerable groups would improve the care timeline and the patient's prognosis.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals over 18 years of age.
• With long COVID, according to the World Health Organization (WHO) consensus definition
• Having a history of fatigue symptoms
• Obtain 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 imaginable
• Have an Android or iOS smartphone compatible with the intervention program.
• Agree to participate in the study and sign the informed consent form
• Willingness and availability to comply with all study guidelines and procedures

Exclusion criteria

• Hospital admission during the period of study participation.
• Participation in another study with pharmacological treatment
• Patients 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 physician
• With mobility restrictions that limit the patient's ability to perform mild physical activity
• Being pregnant
• Patients who do not understand or speak Catalan or Spanish.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Solution group

Experimental group

Description:

The study sample will consist of 60 patients, 30 of whom will be randomly assigned to a control group and 30 to the experimental group. Validated questionnaires will be administered to the participants of both groups, at the beginning of the study, at 1 month and 3 months by Microsoft Forms. In addition, the experimental group will be given a smartwatch to each person which will collect real-time data on activity, training and sleep in a completely anonymous way. Also, through a mobile application, the patient of the experimental group will answer questionnaires about health status perception. The application has also been trained to provide educational content and motivational messages to support the patient's self-management. The data provided by patients in both groups of the study will be coded, in order to maintain the confidentiality of the individual.

Treatment:

Behavioral: Adhera® Fatigue Digital Program

Control group

No Intervention group

Description:

The study sample will consist of 60 patients, 30 of whom will be randomly assigned to a control group and 30 to the experimental group. Validated questionnaires will be administered to the participants of both groups, at the beginning of the study, at 1 month and 3 months by Microsoft Forms.