- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01991782
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
December 26, 2014 updated by: Manish Sethi, Vanderbilt University
The purpose of this study is to determine whether telemedicine video calls for follow-up visits between patients and their orthopaedic trauma surgeons has an impact on patient satisfaction, quality of life, and treatment adherence.
This study will also assess the feasibility of telemedicine as a medium for follow-up visits.
Study Overview
Detailed Description
Patients who are over the age of 18 years with closed fractures treated at Vanderbilt University Medical Center by the Orthopaedic Trauma Department will be recruited into the study into one of two arms: a telemedicine arm in which the patient will have some of his or her visits conducted through video calls, and a control arm in which all of the visits for the patient will be in-person at the Vanderbilt University Orthopaedic Trauma Clinic.
Comparisons between the two groups will be made through surveys administered to the patients half-way through the study and at the conclusion of the study, and comparisons will be made using standard statistical tests.
The feasibility of telemedicine as a medium for follow-up visits in lieu of in-person visits will be assessed in this study.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37212
- Vanderbilt University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home
Exclusion Criteria:
- patients as part of vulnerable populations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Control patients with all follow-up visits in person at the Vanderbilt Orthopaedic Trauma clinic (2 weeks, 6 weeks, 3 months, and 6 months post-operative).
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Experimental: Telemedicine
Experimental cohort with two follow-up visits (6 weeks and 6 months) occurring via telemedicine video calls and two follow-up visits (2 weeks and 3 months) occurring in person.
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Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction and Clinical Outcomes at Conclusion
Time Frame: 6 month
|
Surveys will be administered to all patients in both arms of the study at the conclusion of the study to assess patient satisfaction with their treatment arms.
Furthermore, all clinical outcomes for patients with be addressed at this point to note fracture healing status, any development of complications, and any redefinition of goals of care.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Manish K Sethi, MD, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 11, 2012
First Submitted That Met QC Criteria
November 17, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
December 30, 2014
Last Update Submitted That Met QC Criteria
December 26, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120725
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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