Clinical trial NCT05631171: Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
Official title: COVIDAI: Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Acute COVID19 Syndrome
Fatigue
Keywords: Long COVID
digital health
fatigue
emotional health
behavioral intervention
mental wellbeing
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Institut Català de la Salut
name: Andaluz Health Service
First posted: 2022-11-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental intervention arm in parallel to control arm
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: baseline
measure: Health-related quality of life
timeFrame: month 1
measure: Health-related quality of life
timeFrame: month 3
measure: Fatigue
timeFrame: baseline
measure: Fatigue
timeFrame: month 1
measure: Fatigue
timeFrame: month 3
measure: Emotional wellness
timeFrame: baseline
measure: Emotional wellness
timeFrame: month 1
measure: Emotional wellness
timeFrame: month 3
Secondary outcomes:
measure: Behavioral outcome: Usability
timeFrame: month 1
measure: Behavioral outcome: Usability
timeFrame: month 3
measure: Fatigue-related symptomatology
timeFrame: month 1
measure: Fatigue-related symptomatology
timeFrame: month 3
measure: Mood
timeFrame: baseline
measure: Mood
timeFrame: month 1
measure: Mood
timeFrame: month 3
measure: Social, psychological and emotional wellness
timeFrame: baseline
measure: Social, psychological and emotional wellness
timeFrame: month 1
measure: Social, psychological and emotional wellness
timeFrame: month 3
measure: Self-efficacy
timeFrame: baseline
measure: Self-efficacy
timeFrame: month 1
measure: Self-efficacy
timeFrame: month 3
Other outcomes:
Locations:
city: Sant Fruitós de Bages
country: Spain
facility: Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
state: Barcelona
city: Sevilla
country: Spain
facility: Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte
Study officials:
References: