Post-Acute COVID-19 SyndromeHINTNCT06218849
Hybrid Interactive Avatars for Post-COVID Sufferers
An observational study of Post-Acute COVID-19 Syndrome, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The goal of this observational study is to evaluate an app to improve communication and information flows for persons suffering from Post-COVID-19 syndrome (PCS). The main questions it aims to answer are: How can custom virtual characters (avatars) help to collect more data for the diagnosis of PCS? Can conversations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2024to Dec 2025
- Phase
- Observational
- 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
Study population: The study will include female and male subjects who have been proven to have COVID-19 and are at least 18 years old.
Who may be able to join
- Existence of a declaration of consent
- Stable clinical condition
- Diagnosis of Post-COVID syndrome according to the World Health Organization (WHO):
- Symptoms persist for more than 12 weeks
- Duration: at least 2 months
- Etiology: no alternative diagnosis
- Progression: persistent, recurrent, fluctuating
Who cannot join
- Known psychiatric or somatic illness that can explain the symptoms
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Cologne
Cologne, Northrhine-Westfalia, 50937
Clara Lehmann, MD, +49221 4784433, clara.lehmann@uk-koeln.de
Cristina Polidori, MD, +49221 47832753, maria.polidori-nelles@uk-koeln.de
About this study
The goal of this observational study is to evaluate an app to improve communication and information flows for persons suffering from Post-COVID-19 syndrome (PCS). The main questions it aims to answer are:
- How can custom virtual characters (avatars) help to collect more data for the diagnosis of PCS?
- Can conversations with virtual (mobile) characters (avatars) and the presentation of health data help to improve the diagnosis and understanding of PCS?
- How should these virtual characters (avatars) be designed for people with PCS and healthcare professionals to be useful in the long term? This concerns appearance, dialog, personality and functions.
Participants will be asked to use and test the app and take part in two interviews at the beginning and end of the study.
Read the detailed description
The overarching goal of the HINT project is to develop an app that people affected by PCS can use on their own devices in a language of their choice (e.g. their native language) to increase their health and data literacy about PCS and to provide socially equitable access to PCS care. Multilingual avatars are used for independent data collection, as the embodiment of interaction systems offers advantages for health queries. The data collected during the survey and - if desired - data from wearables are combined with historical data from the participants, processed and visualized. This allows patients to communicate with their avatar as well as with medical staff about their illness and its progression without language barriers affecting treatment. The avatar can also inform patients about new research findings on PCS. To this end, the system's level of knowledge is constantly compared with the current state of science; new findings are prepared for the target group and added to the knowledge base. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The participatory and iterative development of the system, which also involves medical staff, contributes to overarching issues relating to co-creation approaches in the healthcare sector.
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Post-COVID-19 syndrome, Avatar, App development
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Final evaluation of the application field tests
Following the successful completion of the field test (phase 2), a full evaluation will be carried out. The overall system and its use will be evaluated, taking into account both the perspective of those affected by PCS and that of the medical staff.
Measured: 24 months after initiation of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences Cologne, Humanizing Technologies GmbH
- Responsible party
- Principal investigator, Clara Lehmann, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218849
- Sponsor's protocol ID
- 16SV9183
- Acronym
- HINT
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Interactive Avatars for Post-COVID Sufferers
- ClinicalTrials.gov ID
- NCT06218849
- Acronym / sponsor ID
- HINT / 16SV9183
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- Post-COVID-19 syndrome, Avatar, App development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- University of Applied Sciences Cologne, Humanizing Technologies GmbH
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (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 goal of this observational study is to evaluate an app to improve communication and information flows for persons suffering from Post-COVID-19 syndrome (PCS). The main questions it aims to answer are:
- How can custom virtual characters (avatars) help to collect more data for the diagnosis of PCS?
- Can conversations with virtual (mobile) characters (avatars) and the presentation of health data help to improve the diagnosis and understanding of PCS?
- How should these virtual characters (avatars) be designed for people with PCS and healthcare professionals to be useful in the long term? This concerns appearance, dialog, personality and functions.
Participants will be asked to use and test the app and take part in two interviews at the beginning and end of the study.
Detailed description
The overarching goal of the HINT project is to develop an app that people affected by PCS can use on their own devices in a language of their choice (e.g. their native language) to increase their health and data literacy about PCS and to provide socially equitable access to PCS care. Multilingual avatars are used for independent data collection, as the embodiment of interaction systems offers advantages for health queries. The data collected during the survey and - if desired - data from wearables are combined with historical data from the participants, processed and visualized. This allows patients to communicate with their avatar as well as with medical staff about their illness and its progression without language barriers affecting treatment. The avatar can also inform patients about new research findings on PCS. To this end, the system's level of knowledge is constantly compared with the current state of science; new findings are prepared for the target group and added to the knowledge base. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The participatory and iterative development of the system, which also involves medical staff, contributes to overarching issues relating to co-creation approaches in the healthcare sector.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include female and male subjects who have been proven to have COVID-19 and are at least 18 years old.
Key inclusion criteria (7 listed)
- Existence of a declaration of consent
- Stable clinical condition
- Diagnosis of Post-COVID syndrome according to the World Health Organization (WHO):
Key exclusion criteria (1 listed)
- Known psychiatric or somatic illness that can explain the symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Final evaluation of the application field tests
Time frame: 24 months after initiation of the study
Following the successful completion of the field test (phase 2), a full evaluation will be carried out. The overall system and its use will be evaluated, taking into account both the perspective of those affected by PCS and that of the medical staff.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute COVID-19 Syndrome, run by University Hospital of Cologne at 1 site in Germany.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Lehmann, MD (+49221 4784433, clara.lehmann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final evaluation of the application field tests (time frame: 24 months after initiation of the study). 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 23 Jan 2024.