TelemedicineNCT01991782
The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
A study testing Telemedicine in people with Telemedicine and Fracture, run by Vanderbilt University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Fracture
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2014
- 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
- adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home
Who cannot join
- patients as part of vulnerable populations
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Telemedicine, Fracture
- Being tested
- Telemedicine
- Keywords
- Telemedicine, Fracture, Orthopaedics
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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). |
| Telemedicine | Experimental | 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. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction and Clinical Outcomes at Conclusion
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Sethi, Vanderbilt University
- Investigators
- Manish K Sethi, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991782
- Sponsor's protocol ID
- 120725
- Status last verified
- Dec 2014
- First submitted
- 11 Jul 2012
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
- ClinicalTrials.gov ID
- NCT01991782
- Acronym / sponsor ID
- 120725
- Conditions
- Telemedicine, Fracture
- Keywords
- Telemedicine, Fracture, Orthopaedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Nov 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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). |
| Telemedicine | Experimental | Other: TelemedicineExperimental 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home
Key exclusion criteria (1 listed)
- patients as part of vulnerable populations
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 |
|---|---|---|
| TelemedicinePatients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls. | Other | Telemedicine |
Primary outcome
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.
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 30 Dec 2014.
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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.
Manish K Sethi, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Telemedicine and Fracture, run by Vanderbilt University at 1 site in United States.
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: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Patient Satisfaction and Clinical Outcomes at Conclusion (time frame: 6 month). 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 30 Dec 2014.