Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298578
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures A Randomized Clinical Trial
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to validate the feasibility of a remote patient monitoring RPM system using Mobile App in terms of the frequency of data interruptions and patient acceptance
The secondary objective is to Improve quality of life and early prediction of the complications
The secondary objective is to Improve quality of life and early prediction of the complications
Detailed Description:
Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation The percentage of patients with lost follow up is significantly high Previously all other studies mainly focused on the radiographic outcome after acetabular fractures and rarely on patient reported functional outcomes and quality of lifeThe use of patient-reported outcome measures PROMs is increasing and may lead to modifications of treatment Recent technologic advances namely smartphones capable of measuring outcomes after acetabular fractures are now very important in quantifying value-based care This was previously accomplished through office assessments and surveys with variable follow-up but this strategy lacks continuous and complete data Studies show that these remote modes of follow-up are safe and that patients are as equally satisfied with them as they are with in-person follow- up care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None