Acetabular FractureNCT04393571
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
A study testing Mobile application in people with Acetabular Fracture and PROMs, run by Assiut University.
Trial summary
Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fracture, PROMs, Mobile Phone Use
- What is being tested?
- Mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients younger than 18 years.
About this study
Official title: The Utility of Mobile Based Patient Reported Outcome Measures(PROMS) in Patients With Acetabular Fractures: A Randomized Controlled Trial.
Acetabular fractures are articular fractures involving the hip joint that needs anatomical reduction and a strict long follow up after fixation.
Read the 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
- Conditions
- Acetabular Fracture, PROMs, Mobile Phone Use
- Being tested
- Mobile application
- Medical subject headings
- Cell Phone Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationOther
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
| Study group | Role | What they receive |
|---|---|---|
| conventional follow up patients | Experimental | Not described Receives: Other: Mobile application |
| Mobile app follow up patients | Experimental | Not described Receives: Other: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at least one year follow up
Secondary outcomes (1)
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.
Measured: at least one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- AO Trauma
- Responsible party
- Principal investigator, Mohammed Kamal Abdelnasser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393571
- Sponsor's protocol ID
- TUOMBPROMSIPWAFARCT
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Mobile Based Patient Reported Outcome Measures(PROMS) in Patients With Acetabular Fractures: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04393571
- Acronym / sponsor ID
- TUOMBPROMSIPWAFARCT
- Conditions
- Acetabular Fracture, PROMs, Mobile Phone Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- AO Trauma
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional follow up patients | Experimental | Other: Mobile application |
| Mobile app follow up patients | Experimental | Other: Mobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients younger than 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationtelemedicine 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 | Other | Mobile app follow up patients, conventional follow up patients |
Primary outcome
the percentage of missed follow up data in both groups at 12 months postoperatively
Time frame: at least one year follow up
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).
1 secondary outcome
the ability of the mobile application to rapidly detect the occurrence of serious postoperative complication.
Time frame: at least one year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Acetabular Fracture and PROMs, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of missed follow up data in both groups at 12 months postoperatively (time frame: at least one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.