NCT04827342

Brief Summary

This study is to explore with a feasibility and functionality test the potential of the Ada DDSS prototype with cases of dyspnea patients using the data collected at the Emergency Department (ED) and the ward of Internal medicine of the University Hospital Basel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 6, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 26, 2021

Last Update Submit

March 29, 2021

Conditions

Keywords

Ada DDSS prototypeDiagnostic Decision Support System (DDSS)

Outcome Measures

Primary Outcomes (2)

  • Feasibility of the Ada DDSS prototype

    Feasibility of the Ada DDSS prototype simultaneously to standard documentation by the medical staff.

    during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)

  • Subjectively perceived benefit from using the Ada DDSS prototype

    Subjectively perceived benefit from using the Ada DDSS prototype (during patient journey in the hospital) assessed by a physician.

    during hospital stay (presentation at the ED through to admission in the ward of Internal Medicine, in the average 1 week)

Interventions

Entry of patients' data (medical history, symptoms and findings) in the Ada DDSS prototype. The tool then automatically creates a list of possible diagnostic suggestions based on the information, which are compared with the diagnoses of the attending physician.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with dyspnoea who come to the emergency room of the University Hospital Basel and are to be transferred to the Internal Medicine Ward due to their illness

You may qualify if:

  • Dyspnea as the main symptom when entering the emergency room
  • Existence of written consent
  • The patient is able to speak, understand and read German or English.

You may not qualify if:

  • Inability or unwillingness to understand and comply with study procedures due to:
  • Language problems
  • Acute mental disorders
  • Dementia
  • Clinical instability (e..B. resuscitation treatment, non-invasive ventilation, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Timiliotis J, Blumke B, Serfozo PD, Gilbert S, Ondresik M, Turk E, Hirsch MC, Eckstein J. A Novel Diagnostic Decision Support System for Medical Professionals: Prospective Feasibility Study. JMIR Form Res. 2022 Mar 24;6(3):e29943. doi: 10.2196/29943.

MeSH Terms

Conditions

Dyspnea

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jens Eckstein, Prof. Dr. med.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2021

First Posted

April 1, 2021

Study Start

May 6, 2020

Primary Completion

August 7, 2020

Study Completion

August 7, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Locations