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

Fatigue Clinical Trial

— COVIDAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631171
• Other study ID #: FAT-22-002
• Status: Completed
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Adhera Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue

Intervention

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.

Locations

Country	Name	City	State
Spain	Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut	Sant Fruitós de Bages	Barcelona
Spain	Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Adhera Health, Inc.	Andaluz Health Service, Institut Català de la Salut

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.	baseline
Primary	Health-related quality of life	measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.	month 1
Primary	Health-related quality of life	measured using the 5-level EQ-5D (EQ-5D-5L) questionnaire from Herdman et al., 2011. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.	month 3
Primary	Fatigue	Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.	baseline
Primary	Fatigue	Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.	month 1
Primary	Fatigue	Perceived mental and physical fatigue will be assessed via the Fatigue Assessment Scale (FAS), from De Vries et al., 2004. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.	month 3
Primary	Emotional wellness	measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.	baseline
Primary	Emotional wellness	measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.	month 1
Primary	Emotional wellness	measured using the Depression Anxiety Stress Scale (DASS-21) from Lovibond, 1995. Scoring ranges from 0 to more than 34, with the lowest numbers being the normal ones and the highest representing extremely severe depression, anxiety and stress.	month 3
Secondary	Behavioral outcome: Usability	Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.	month 1
Secondary	Behavioral outcome: Usability	Digital health solution usability and acceptance assessed with the System Usability Scale (SUS) questionnaire from Bangor et al., 2008. SUS can range between score 0 and 100, with higher values representing higher usability.	month 3
Secondary	Fatigue-related symptomatology	questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.	month 1
Secondary	Fatigue-related symptomatology	questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.	month 3
Secondary	Mood	measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.	baseline
Secondary	Mood	measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.	month 1
Secondary	Mood	measured using the Positive and Negative Affect Schedule (PANAS) from Watson et al., 1988. Positive Affect Score can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score can range from 10 - 50, with lower scores representing lower levels of negative affect.	month 3
Secondary	Social, psychological and emotional wellness	Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting = 1 of 3 hedonic signs and = 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced "every day" or "5-6 times a week." Higher scores indicate greater levels of positive well-being.	baseline
Secondary	Social, psychological and emotional wellness	Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting = 1 of 3 hedonic signs and = 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced "every day" or "5-6 times a week." Higher scores indicate greater levels of positive well-being.	month 1
Secondary	Social, psychological and emotional wellness	Mental Health Continuum Short Form (MHC-SF) from Keyes et al., 2008. Items are summed, yielding a total score ranging from 0 to 70. Subscale scores range from 0 to 15 for the emotional (hedonic) well-being, from 0 to 25 for social well-being, and from 0 to 30 for psychological well-being. Flourishing mental health is defined by reporting = 1 of 3 hedonic signs and = 6 of 11 eudaimonic signs (social and psychological subscales combined) experienced "every day" or "5-6 times a week." Higher scores indicate greater levels of positive well-being.	month 3
Secondary	Self-efficacy	Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	baseline
Secondary	Self-efficacy	Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	month 1
Secondary	Self-efficacy	Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.	month 3

External Links

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