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

Primary Purpose

Post-Acute COVID19 Syndrome, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Adhera® Fatigue Digital Program
Sponsored by
Adhera Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-Acute COVID19 Syndrome focused on measuring Long COVID, digital health, fatigue, emotional health, behavioral intervention, mental wellbeing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
  • Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Solution group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Fatigue-related symptomatology
questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
Fatigue-related symptomatology
questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 18, 2022
Last Updated
July 19, 2023
Sponsor
Adhera Health, Inc.
Collaborators
Institut Català de la Salut, Andaluz Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT05631171
Brief Title
Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
Acronym
COVIDAI
Official Title
COVIDAI: Feasibility Study of Adhera® Fatigue Digital Program for Patients With Long COVID-related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adhera Health, Inc.
Collaborators
Institut Català de la Salut, Andaluz Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Acute COVID19 Syndrome, Fatigue
Keywords
Long COVID, digital health, fatigue, emotional health, behavioral intervention, mental wellbeing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental intervention arm in parallel to control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solution group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Adhera® Fatigue Digital Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
baseline
Title
Health-related quality of life
Description
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.
Time Frame
month 1
Title
Health-related quality of life
Description
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.
Time Frame
month 3
Title
Fatigue
Description
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.
Time Frame
baseline
Title
Fatigue
Description
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.
Time Frame
month 1
Title
Fatigue
Description
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.
Time Frame
month 3
Title
Emotional wellness
Description
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.
Time Frame
baseline
Title
Emotional wellness
Description
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.
Time Frame
month 1
Title
Emotional wellness
Description
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.
Time Frame
month 3
Secondary Outcome Measure Information:
Title
Behavioral outcome: Usability
Description
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.
Time Frame
month 1
Title
Behavioral outcome: Usability
Description
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.
Time Frame
month 3
Title
Fatigue-related symptomatology
Description
questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
Time Frame
month 1
Title
Fatigue-related symptomatology
Description
questions regarding perceived anxiety, depression, stress, sleep disorders or emotional status.
Time Frame
month 3
Title
Mood
Description
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.
Time Frame
baseline
Title
Mood
Description
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.
Time Frame
month 1
Title
Mood
Description
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.
Time Frame
month 3
Title
Social, psychological and emotional wellness
Description
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.
Time Frame
baseline
Title
Social, psychological and emotional wellness
Description
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.
Time Frame
month 1
Title
Social, psychological and emotional wellness
Description
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.
Time Frame
month 3
Title
Self-efficacy
Description
Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time Frame
baseline
Title
Self-efficacy
Description
Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time Frame
month 1
Title
Self-efficacy
Description
Self-Efficacy Scale (GSE) from Schwartzer & Jerusalem 1995. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Time Frame
month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
City
Sant Fruitós de Bages
State/Province
Barcelona
ZIP/Postal Code
08272
Country
Spain
Facility Name
Servicio Andaluz de Salud - Distrito Sanitario Aljarafe-Sevilla Norte
City
Sevilla
ZIP/Postal Code
41008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.withings.com/de/en/scanwatch
Description
Withings Scanwatch wearable

Learn more about this trial

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

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