Post Acute COVID-19 SyndromeAIDANCT05483829
Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients Affected by Fatigue (AIDA)
A study testing Adhera® Fatigue for Long COVID program in people with Post Acute COVID-19 Syndrome, run by Adhera Health, Inc. at 1 site in Spain.
Trial summary
The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Acute COVID-19 Syndrome
- What is being tested?
- Adhera® Fatigue for Long COVID program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2022to 28 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal adults (older than 18)
- Long COVID diagnosis within the last year
- In possession of a compatible smartphone (Android OS v4.4 or higher)
- Reporting any of these symptoms:
- Fatigue
- Dyspnea
Show all 10Show fewer
- Anxiety
- Stress
- Depression
- Sleep disorder
Who cannot join
- Hospital admission during follow-up due to pathology not related to COVID-19
- Patients without digital literacy or who cannot use the mobile application.
- Known severe psychiatric illness or cognitive impairment
- Being pregnant (or suspected to be pregnant)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gerencia Territorial de la Catalunya Central - Institut Catala de la Salut
Sant Fruitós de Bages, Catalonia, 08272
About this study
Official title: AIDA - A Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients: Feasibility Study.
The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients.
Read the detailed description
The study will explore the usability and engagement of a digital program designed for long covid patients affected by fatigue. The digital program relies on the Adhera® personalized digital health solution that includes personalized patient education and support, monitoring using psychometrics and wearables, and mental wellbeing exercises. The patients access the mobile solution via a mobile app. A total of 15 patients will be recruited and use the mobile solution for one month.
- Conditions
- Post Acute COVID-19 Syndrome
- Being tested
- Adhera® Fatigue for Long COVID program
- Keywords
- Long COVID, mhealth, digital health, emotional health, behavioral intervention, mental wellbeing, mood disturbance, emotional adjustment
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhera® Fatigue for Long COVID programBehavioural
Adhera® for the Long COVID program, which includes an application and a smartwatch, supported by 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 4 weeks to detect biometric and psychometric (patient-reported outcomes) information.
| Study group | Role | What they receive |
|---|---|---|
| Long COVID prospective group | Experimental | Not described Receives: Behavioral: Adhera® Fatigue for Long COVID program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral outcome: Usability
mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.
Measured: At week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Aug 2022
- Primary completion28 Aug 2022
- Study completion28 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adhera Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Responsible party
- Sponsor
- Investigators
- Josep Vidal-Alaball, MD, PhD, Principal investigator, Institut Universitari per a la recerca a l'Atencio Primaria de Salut Jordi Gol i Gurina (IDIAPJGol)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483829
- Sponsor's protocol ID
- FAT-22-001
- Acronym
- AIDA
- Status last verified
- Sep 2022
- First submitted
- 28 Jul 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDA - A Digital Health Intervention Based on Artificial Intelligence to Support the Personalized Recovery of Long COVID Patients: Feasibility Study.
- ClinicalTrials.gov ID
- NCT05483829
- Acronym / sponsor ID
- AIDA / FAT-22-001
- Conditions
- Post Acute COVID-19 Syndrome
- Keywords
- Long COVID, mhealth, digital health, emotional health, behavioral intervention, mental wellbeing, mood disturbance, emotional adjustment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Adhera Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AIDA feasibility study builds upon mental health and technology acceptance theoretical frameworks. It examines the feasibility of a mobile-based digital program to support patients with long covid affected by fatigue. The program Adhera ® Fatigue Self-management is adapted for long covid patients.
Detailed description
The study will explore the usability and engagement of a digital program designed for long covid patients affected by fatigue. The digital program relies on the Adhera® personalized digital health solution that includes personalized patient education and support, monitoring using psychometrics and wearables, and mental wellbeing exercises. The patients access the mobile solution via a mobile app. A total of 15 patients will be recruited and use the mobile solution for one month.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long COVID prospective group | Experimental | Behavioral: Adhera® Fatigue for Long COVID program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Legal adults (older than 18)
- Long COVID diagnosis within the last year
- In possession of a compatible smartphone (Android OS v4.4 or higher)
- Reporting any of these symptoms:
Key exclusion criteria (4 listed)
- Hospital admission during follow-up due to pathology not related to COVID-19
- Patients without digital literacy or who cannot use the mobile application.
- Known severe psychiatric illness or cognitive impairment
- Being pregnant (or suspected to be pregnant)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhera® Fatigue for Long COVID programAdhera® for the Long COVID program, which includes an application and a smartwatch, supported by 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 4 weeks to detect biometric and psychometric (patient-reported outcomes) information. | Behavioural | Long COVID prospective group |
Primary outcome
Behavioral outcome: Usability
Time frame: At week 4
mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep Vidal-Alaball, MD, PhD principal investigator
Institut Universitari per a la recerca a l'Atencio Primaria de Salut Jordi Gol i Gurina (IDIAPJGol)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhera® Fatigue for Long COVID program in people with Post Acute COVID-19 Syndrome, run by Adhera Health, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral outcome: Usability (time frame: At week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.