Orthopaedic InjuryNCT01971697
Socio-Economic Survey in Uganda
An observational study of Orthopaedic Injury, run by Duke University at 2 sites in 2 countries.
Trial summary
This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Injury
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2013to Mar 2015
- Phase
- Observational
- 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
Study population: Urgent care patients. Patients coming to the ER with a orthopaedic injury.
Who may be able to join
- Subject is a male or female 18 years old or older.
- all patients presented at Mulago National Referral Hospital with orthopedics trauma injuries regardless of age and gender.
Who cannot join
- patients presented with all other conditions other than orthopedics related injuries that may require long term care. Some examples are head injuries leading to long term damage, loss of sights, etc.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Duke University Medical Center
Durham, North Carolina, 27707
About this study
Official title: Short Term Socio-economic Impact Due to Blunt Orthopedics Trauma on the Victims in Uganda
This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed.
Read the detailed description
All patients will be recruited from the orthopedics inpatient wards and emergency department at Mulago National Referral Hospital. Only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. No Protected Health Information (PHI) will be collected throughout the study.
Steps
- Identify patients from Mulago Teaching Hospital
- Enrollment of patients into survey study
- Administer survey to patients at 1st meet up
- Administer survey to doctor-in-charge?
- Compilations of survey results into excel spreadsheet. Participants will be assigned an ID. The study team does not intend to collect any PHI.
- Statistical Analysis.
- Conditions
- Orthopaedic Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate social-economic impact of orthopedics trauma as measured by socio-Economic Questionnaire
A short socio-economic questionnaire will be provided to all enrolled patients
Measured: approximately 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic InjuryStudies of the same condition, open and under way.
- More trials run by Duke 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Richadson, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971697
- Sponsor's protocol ID
- Pro00046624
- Status last verified
- May 2015
- First submitted
- 15 Jul 2013
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Socio-economic Impact Due to Blunt Orthopedics Trauma on the Victims in Uganda
- ClinicalTrials.gov ID
- NCT01971697
- Acronym / sponsor ID
- Pro00046624
- Conditions
- Orthopaedic Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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.
This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed.
Detailed description
All patients will be recruited from the orthopedics inpatient wards and emergency department at Mulago National Referral Hospital. Only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. No Protected Health Information (PHI) will be collected throughout the study.
Steps
- Identify patients from Mulago Teaching Hospital
- Enrollment of patients into survey study
- Administer survey to patients at 1st meet up
- Administer survey to doctor-in-charge?
- Compilations of survey results into excel spreadsheet. Participants will be assigned an ID. The study team does not intend to collect any PHI.
- Statistical Analysis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urgent care patients. Patients coming to the ER with a orthopaedic injury.
Key inclusion criteria (2 listed)
- Subject is a male or female 18 years old or older.
- all patients presented at Mulago National Referral Hospital with orthopedics trauma injuries regardless of age and gender.
Key exclusion criteria (1 listed)
- patients presented with all other conditions other than orthopedics related injuries that may require long term care. Some examples are head injuries leading to long term damage, loss of sights, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate social-economic impact of orthopedics trauma as measured by socio-Economic Questionnaire
Time frame: approximately 20 minutes
A short socio-economic questionnaire will be provided to all enrolled patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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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.
William Richadson, MD principal investigator
Duke University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopaedic Injury, run by Duke University at 2 sites in 2 countries.
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 2 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: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immediate social-economic impact of orthopedics trauma as measured by socio-Economic Questionnaire (time frame: approximately 20 minutes). 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 Oct 2015.