NCT05130697

Brief Summary

This multicenter prospective survey study is designed to evaluate a newly developed mobile app that will support patients with malignant pleural effusion (MPE) treated with an indwelling pleural catheter (IPC). The aim is to test the mobile app with patients with MPE and get user feedback during and at the end of the study period.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

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

July 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

November 5, 2021

Last Update Submit

November 22, 2021

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

  • The % positive usability rating rated via an mHealth App Usability Questionnaire (MAUQ)

    The % positive usability rating rated via an mHealth App Usability Questionnaire (MAUQ)

    2 weeks

Interventions

eMPowEr AppOTHER

A mobile app to support participants in the management of malignant pleural effusions at home

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants (patients with MPE and an IPC in place) are being requested to use a pilot mobile app that is being developed to support them in their symptom management at home and to provide feedback on its usability.

You may qualify if:

  • Patients with MPE and, scheduled for an indwelling pleural catheter (IPC) procedure,
  • Age 18 or older

You may not qualify if:

  • Patients without an iOS smartphone or email account
  • Patients who refuse participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Galway

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 23, 2021

Study Start

July 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

IE(1)