Remote Orthopedic Outpatient Consultation by Help of Telemedicine

December 16, 2015 updated by: University Hospital of North Norway
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

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

  • Norway
      • Tromso, Norway, N-9038
        • Orthopaedic department, Tromso University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent given
  • New referred patients to orthopaedic department (outpatient), UNN, for conditions suitable for telemedicine consultation
  • Follow up consultation of trauma patients (operated/not operated)
  • Follow up consultation after elective orthopaedic surgery (e.g hip prothesis)
  • Follow up of other orthopaedic patients

Exclusion Criteria:

  • Senile dementia
  • Soldiers, prisoners
  • Patients not talking Norwegian, dependent on translator
  • If specialized procedures are required during follow up (e.g. cat-scan, ultrasound etc)
  • Patients requiring a specific doctor

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard consultation
Standard care in orthopaedic outpatient clinic
Other: Standard care in orthopaedic outpatient clinic
Standard care in orthopedic outpatient clinic (usual care)
Experimental: Telemedicine consultation
Orthopaedic care in outpatient clinic by use of telemedicine.
Other: Telemedicine consultation
Outpatient consultation by help of telemedicine (video conference)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and quality of health care
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: up to 1 year after last consultation
Patient satisfaction will be measured based on a total score calculated on the basis of responses to satisfaction questionnaire. Questionnaires will be filled out at each visit/consultation and at 3 months or one year after last consultation.
up to 1 year after last consultation
Cost value
Time Frame: up to 1 year
Travel expenses, escort expenses, equipment and other costs related to patient consultation
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

Helse Nord

Investigators

  • Principal Investigator: Astrid S Buvik, MD, University Hospital North Norway
  • Study Chair: Arvid Smaabrekke, MD, University Hospital North Norway
  • Study Chair: Jan Abel Olsen, PhD, University of Tromso
  • Study Director: Tom Wilsgaard, PhD, University of Tromso, Norway
  • Study Chair: Gunnar Knutsen, MD, PhD, University Hospital NorthNorway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-REK-N-134/2006
  • Personvernombudet,UNN 05.12.06 (Other Identifier: University Hospital North Norway)
  • P-REK-N-134/2006 (REK) (Registry Identifier: Regional ethic comittee, Region North)

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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