The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
Primary Purpose
Acetabular Fracture, PROMs, Mobile Phone Use
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile application
Sponsored by
About this trial
This is an interventional treatment trial for Acetabular Fracture
Eligibility Criteria
Inclusion Criteria:
- all patients older than 18 years old who will have surgery for an acetabular fracture at assiut university hospitals from 1/10/2020 to 30/9/2022.
Exclusion Criteria:
- patients younger than 18 years.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
conventional follow up patients
Mobile app follow up patients
Arm Description
Outcomes
Primary Outcome Measures
the percentage of missed follow up data in both groups at 12 months postoperatively
through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum in assiut university hospital using the Arabic validated form of the 36-Item Short Form Health Survey (SF-36).
Secondary Outcome Measures
the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication.
to record the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication as infection and DVT and notify us by this complication by means of the Red Flag signs which will be added to the application.
Full Information
NCT ID
NCT04393571
First Posted
May 3, 2020
Last Updated
May 17, 2020
Sponsor
Assiut University
Collaborators
AO Trauma
1. Study Identification
Unique Protocol Identification Number
NCT04393571
Brief Title
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
Official Title
The Utility of Mobile Based Patient Reported Outcome Measures(PROMS) in Patients With Acetabular Fractures: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
AO Trauma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.
Detailed Description
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 life. The 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetabular Fracture, PROMs, Mobile Phone Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional follow up patients
Arm Type
Experimental
Arm Title
Mobile app follow up patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Mobile application
Intervention Description
telemedicine is used to overcome distance when patients must travel to receive specialized care. We depend on the available, widely used smartphones via a mobile application to conduct follow up data as regard to patient quality of life and comparing this to conventional follow up visits and whether it help to obtain a complete follow up data
Primary Outcome Measure Information:
Title
the percentage of missed follow up data in both groups at 12 months postoperatively
Description
through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum in assiut university hospital using the Arabic validated form of the 36-Item Short Form Health Survey (SF-36).
Time Frame
at least one year follow up
Secondary Outcome Measure Information:
Title
the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication.
Description
to record the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication as infection and DVT and notify us by this complication by means of the Red Flag signs which will be added to the application.
Time Frame
at least one year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all patients older than 18 years old who will have surgery for an acetabular fracture at assiut university hospitals from 1/10/2020 to 30/9/2022.
Exclusion Criteria:
patients younger than 18 years.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
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