Clinical trial NCT06218849: Hybrid Interactive Avatars for Post-COVID Sufferers
Official title: Hybrid Interactive Avatars for Post-COVID Sufferers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post-Acute COVID-19 Syndrome
Keywords: Post-COVID-19 syndrome
Avatar
App development
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences Cologne
name: Humanizing Technologies GmbH
First posted: 2024-01-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known psychiatric or somatic illness that can explain the symptoms

Primary outcomes:
measure: Final evaluation of the application field tests
timeFrame: 24 months after initiation of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: Northrhine-Westfalia
Study officials:
References: