- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631171
Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue (COVIDAI)
COVIDAI: Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luis Fernandez Luque
- Phone Number: +34 717702622
- Email: luis@adherahealth.com
Study Contact Backup
- Name: Julia Lopez-Guimet
- Email: jlopez@adherahealth.com
Study Locations
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-
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Sevilla, Spain, 41008
- Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte
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Contact:
- Kiko Nuñez
- Phone Number: (+34) 955 057 648
- Email: fjose.nunez@juntadeandalucia.es
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Principal Investigator:
- Luis Luque Romero, MD, PhD
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Barcelona
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Sant Fruitós de Bages, Barcelona, Spain, 08272
- Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Solution group
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.
|
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. |
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life
Time Frame: baseline
|
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
|
Health-related quality of life
Time Frame: month 1
|
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
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Health-related quality of life
Time Frame: month 3
|
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
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Fatigue
Time Frame: baseline
|
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
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Fatigue
Time Frame: month 1
|
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.
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month 1
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Fatigue
Time Frame: month 3
|
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
|
Emotional wellness
Time Frame: baseline
|
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
|
Emotional wellness
Time Frame: month 1
|
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
|
Emotional wellness
Time Frame: month 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral outcome: Usability
Time Frame: month 1
|
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.
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month 1
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Behavioral outcome: Usability
Time Frame: month 3
|
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
|
Fatigue-related symptomatology
Time Frame: month 1
|
questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
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month 1
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Fatigue-related symptomatology
Time Frame: month 3
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questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
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month 3
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Mood
Time Frame: baseline
|
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.
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baseline
|
Mood
Time Frame: month 1
|
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.
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month 1
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Mood
Time Frame: month 3
|
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.
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month 3
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Social, psychological and emotional wellness
Time Frame: baseline
|
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
|
Social, psychological and emotional wellness
Time Frame: month 1
|
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
|
Social, psychological and emotional wellness
Time Frame: month 3
|
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
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Self-efficacy
Time Frame: baseline
|
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
|
Self-efficacy
Time Frame: month 1
|
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
|
Self-efficacy
Time Frame: month 3
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Fatigue
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- FAT-22-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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