Hybrid Interactive Avatars for Post-COVID Sufferers (HINT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Acute COVID-19 Syndrome

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 Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Clara Lehmann, MD; Phone Number: +49221 4784433; Email: clara.lehmann@uk-koeln.de
• Study Contact Backup: Name: Cristina Polidori, MD; Phone Number: +49221 47832753; Email: maria.polidori-nelles@uk-koeln.de

Study Locations

• Germany
  • Northrhine-Westfalia
    • Cologne, Northrhine-Westfalia, Germany, 50937
      • University Hospital Cologne
      • Contact: Clara Lehmann, MD; Phone Number: +49221 4784433; Email: clara.lehmann@uk-koeln.de
      • Contact: Cristina Polidori, MD; Phone Number: +49221 47832753; Email: maria.polidori-nelles@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months after initiation of the study

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Humanizing Technologies GmbH; University of Applied Sciences Cologne

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Post-COVID-19 syndrome; Avatar; App development
• 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; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 16SV9183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No