A Multicenter Survey Study Into Patient Experience With M... | NCT05130697

Studies
A Multicenter Survey Study Into Patient Experience With Mobile Apps

NCT05130697

Sponsor

National University of Ireland, Galway, Ireland

Status

Unknown status

Last Update Posted

Nov 23, 2021Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Malignant Pleural Effusion

Interventions

eMPowEr App

Countries

Ireland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-1089	Other Identifier	The University of Texas MD Anderson Cancer Center

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Apr 30, 2022Estimated

Completion Date

Apr 30, 2022Estimated

First Submitted Date

Nov 5, 2021

First Submission Date that Met QC Criteria

Nov 22, 2021

First Posted Date

Nov 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2021

Last Update Posted Date

Nov 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michelle Tierney, Principal Investigator, National University of Ireland, Galway, IrelandPrincipal Investigator

Lead Sponsor

National University of Ireland, Galway, IrelandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
eMPowEr App	Other	A mobile app to support participants in the management of malignant pleural effusions at home

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals Galway	Recruiting	Galway			Ireland

Condition Browse Module

MeSH Terms

ID	Term
D016066	Pleural Effusion, Malignant

Ancestor Terms

ID	Term
D010997	Pleural Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided