The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial
1 other identifier
observational
126
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 7, 2024
March 1, 2024
1.7 years
March 1, 2024
March 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of missed follow up data in both groups postoperatively through assessing the patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum using the Arabic validated form of (SF-36)
Comparison between follow up using mobile app versus in person clinic visit
Baseline
Secondary Outcomes (1)
Quality of life scoring (Arabic validated form of (SF-36) and early prediction of the complications
Baseline
Study Arms (2)
In person follow up
mobile app follow up
Eligibility Criteria
All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
You may qualify if:
- All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital.
You may not qualify if:
- Patients younger than 18years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (14)
JUDET R, JUDET J, LETOURNEL E. FRACTURES OF THE ACETABULUM: CLASSIFICATION AND SURGICAL APPROACHES FOR OPEN REDUCTION. PRELIMINARY REPORT. J Bone Joint Surg Am. 1964 Dec;46:1615-46. No abstract available.
PMID: 14239854BACKGROUNDMears DC, Velyvis JH, Chang CP. Displaced acetabular fractures managed operatively: indicators of outcome. Clin Orthop Relat Res. 2003 Feb;(407):173-86. doi: 10.1097/00003086-200302000-00026.
PMID: 12567145BACKGROUNDFrietman B, Biert J, Edwards MJR. Patient-reported outcome measures after surgery for an acetabular fracture. Bone Joint J. 2018 May 1;100-B(5):640-645. doi: 10.1302/0301-620X.100B5.BJJ-2017-0871.R3.
PMID: 29701094BACKGROUNDGiannoudis PV, Grotz MR, Papakostidis C, Dinopoulos H. Operative treatment of displaced fractures of the acetabulum. A meta-analysis. J Bone Joint Surg Br. 2005 Jan;87(1):2-9.
PMID: 15686228BACKGROUNDTannast M, Najibi S, Matta JM. Two to twenty-year survivorship of the hip in 810 patients with operatively treated acetabular fractures. J Bone Joint Surg Am. 2012 Sep 5;94(17):1559-67. doi: 10.2106/JBJS.K.00444.
PMID: 22992846BACKGROUNDClarke-Jenssen J, Roise O, Storeggen SAO, Madsen JE. Long-term survival and risk factors for failure of the native hip joint after operatively treated displaced acetabular fractures. Bone Joint J. 2017 Jun;99-B(6):834-840. doi: 10.1302/0301-620X.99B6.BJJ-2016-1013.R1.
PMID: 28566406BACKGROUNDDodd A, Osterhoff G, Guy P, Lefaivre KA. Assessment of functional outcomes of surgically managed acetabular fractures: a systematic review. Bone Joint J. 2016 May;98-B(5):690-5. doi: 10.1302/0301-620X.98B5.36292.
PMID: 27143743BACKGROUNDRamkumar PN, Haeberle HS, Ramanathan D, Cantrell WA, Navarro SM, Mont MA, Bloomfield M, Patterson BM. Remote Patient Monitoring Using Mobile Health for Total Knee Arthroplasty: Validation of a Wearable and Machine Learning-Based Surveillance Platform. J Arthroplasty. 2019 Oct;34(10):2253-2259. doi: 10.1016/j.arth.2019.05.021. Epub 2019 May 16.
PMID: 31128890BACKGROUNDSanger PC, Hartzler A, Han SM, Armstrong CA, Stewart MR, Lordon RJ, Lober WB, Evans HL. Patient perspectives on post-discharge surgical site infections: towards a patient-centered mobile health solution. PLoS One. 2014 Dec 1;9(12):e114016. doi: 10.1371/journal.pone.0114016. eCollection 2014.
PMID: 25436912BACKGROUNDWebb CL, Waugh CL, Grigsby J, Busenbark D, Berdusis K, Sahn DJ, Sable CA; American Society of Echocardiography Telemedicine Collaborators' Group. Impact of telemedicine on hospital transport, length of stay, and medical outcomes in infants with suspected heart disease: a multicenter study. J Am Soc Echocardiogr. 2013 Sep;26(9):1090-8. doi: 10.1016/j.echo.2013.05.018. Epub 2013 Jul 13.
PMID: 23860093BACKGROUNDHwa K, Wren SM. Telehealth follow-up in lieu of postoperative clinic visit for ambulatory surgery: results of a pilot program. JAMA Surg. 2013 Sep;148(9):823-7. doi: 10.1001/jamasurg.2013.2672.
PMID: 23842982BACKGROUNDMishra A, Kapoor L, Mishra SK. Post-operative care through tele-follow up visits in patients undergoing thyroidectomy and parathyroidectomy in a resource-constrained environment. J Telemed Telecare. 2009;15(2):73-6. doi: 10.1258/jtt.2008.080808.
PMID: 19246606BACKGROUNDSeto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
PMID: 22356799BACKGROUNDGray RT, Sut MK, Badger SA, Harvey CF. Post-operative telephone review is cost-effective and acceptable to patients. Ulster Med J. 2010 May;79(2):76-9.
PMID: 21116423BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
April 1, 2024
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
March 7, 2024
Record last verified: 2024-03