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| Sponsors and Collaborators: |
University Hospital of North Norway Helse Nord |
|---|---|
| Information provided by: | University Hospital of North Norway |
| ClinicalTrials.gov Identifier: | NCT00616837 |
Purpose
Patients from 4 local communities in northern Norway referred (either new or follow up) to orthopaedic department, University hospital of Northern Norway for outpatient consultation, are randomly assigned to either remote consultation by use of telemedicine (camera and screen), or standard consultation at the hospital. There are x-ray facilities also at the remote site. The patients randomized to telemedicine consultation meet special trained nurses at the remote site, but doctor only by video conference. The patients will be followed for up to one year. The primary endpoint is quality of care achieved with the telemedicine consultation as compared to standard outpatient consultation (assessed by questionnaires filled out by the doctor involved). Secondary end points are patient satisfaction assessed by questionnaires and economic analyses. The study hypothesis is non-inferiority of telemedicine consultation vs. conventional, outpatient consultation.
| Condition | Intervention |
|---|---|
|
Orthopedic Conditions |
Other: Telemedicine consultation |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Remote Orthopedic Outpatient Consultation by Help of Telemedicine |
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Standard orthopaedic outpatient clinic
|
Other: Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)
|
|
2: Experimental
Orthopaedic outpatient clinic by help of telemedicine
|
Other: Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Astrid S Buvik, MD | +47 77 62 60 00 | astrid.buvik@unn.no |
| Norway | |
| Orthopaedic department, Tromso University Hospital | Recruiting |
| Tromso, Norway, N-9038 | |
| Contact: Astrid Buvik, MD +47 77 62 60 00 astrid.buvik@unn.no | |
| Principal Investigator: Astrid Buvik, MD | |
| Principal Investigator: | Astrid S Buvik, MD | University Hospital North Norway |
| Study Chair: | Arvid Smaabrekke, MD | University Hospital North Norway |
| Study Director: | Jan Abel Olsen, PhD | University of Tromso |
More Information
| Responsible Party: | University Hospital of North Norway ( Astrid Buvik MD ) |
| Study ID Numbers: | P-REK-N-134/2006, Personvernombudet,UNN 05.12.06, P-REK-N-134/2006 (REK) |
| Study First Received: | January 22, 2008 |
| Last Updated: | February 14, 2008 |
| ClinicalTrials.gov Identifier: | NCT00616837 History of Changes |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
|
Remote consultation/*methods Orthopaedics methods Telemedicine Follow-up study Ambulatory care |
