NCT05043220

Brief Summary

We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

September 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

September 13, 2021

Last Update Submit

November 19, 2024

Conditions

Telemedicine

Outcome Measures

Primary Outcomes (2)

  • Compliance

    Compliance is defined as wearing time of the in-ear-sensor.

    3 months

  • robustness of the ppg-signal

    number and duration of the ppg-signal transmitted

    3 months

Secondary Outcomes (7)

  • number of correct- and false-positive alerts

    3 months

  • number of contacts and hospitalization rates

    3 months

  • infections

    3 months

  • therapy modifications

    3 months

  • effect on quality of life

    3 months

  • +2 more secondary outcomes

Study Arms (1)

Telemedicine

EXPERIMENTAL

Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app

Device: PPG and PROM

Interventions

PPG and PROMDEVICE

description will follow

Telemedicine

Eligibility Criteria

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

You may qualify if:

  • gynecological cancer
  • indication for systemic cancer therapy
  • patients who are legally competent and able to understand and follow instructions of the study staff
  • present informed consent

You may not qualify if:

  • no use if internet or applications
  • persons who are in a dependency or employment relationship with the study center
  • positive proof of COVID-19
  • affection of the external auditory canal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar, Frauenklinik, Technische Universität München

Munich, 81675, Germany

Location

Study Officials

  • Heike Jansen, Dr. med

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

  • Marion Kiechle, Prof. Dr. med.

    Technical University of Munich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 14, 2021

Study Start

September 29, 2021

Primary Completion

October 31, 2022

Study Completion

April 30, 2025

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations

DE(1)