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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05631171
Other study ID # FAT-22-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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