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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acetabular Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 3, 2020
    Last Updated
    May 17, 2020
    Sponsor
    Assiut University
    Collaborators
    AO Trauma
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    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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