NCT06218849

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

January 22, 2024

Last Update Submit

January 22, 2024

Conditions

Keywords

Post-COVID-19 syndromeAvatarApp development

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Known psychiatric or somatic illness that can explain the symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Cologne

Cologne, Northrhine-Westfalia, 50937, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Clara Lehmann

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 23, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations