Orthopedic DisordersNCT00616837
Remote Orthopedic Outpatient Consultation by Help of Telemedicine
A study testing Telemedicine consultation in people with Orthopedic Disorders, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthopedic Disorders
- What is being tested?
- Telemedicine consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2007to Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Orthopedic Disorders
- Being tested
- Telemedicine consultation, Standard care in orthopaedic outpatient clinic
- Keywords
- Remote consultation/*methods, Orthopaedics methods, Telemedicine, Follow-up study, Ambulatory care
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine consultationOther
Outpatient consultation by help of telemedicine (video conference)
Standard care in orthopaedic outpatient clinicOther
Standard care in orthopedic outpatient clinic (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Standard consultation | Active comparator | Standard care in orthopaedic outpatient clinic Receives: Other: Standard care in orthopaedic outpatient clinic |
| Telemedicine consultation | Experimental | Orthopaedic care in outpatient clinic by use of telemedicine. Receives: Other: Telemedicine consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and quality of health care
Measured: 1 year
Secondary outcomes (2)
Patient satisfaction
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.
Measured: up to 1 year after last consultation
Cost value
Travel expenses, escort expenses, equipment and other costs related to patient consultation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord
- Responsible party
- Sponsor
- Investigators
- Astrid S Buvik, MD, Principal investigator, University Hospital North NorwayArvid Smaabrekke, MD, Study chair, University Hospital North NorwayJan Abel Olsen, PhD, Study chair, University of TromsoTom Wilsgaard, PhD, Study director, University of Tromso, NorwayGunnar Knutsen, MD, PhD, Study chair, University Hospital NorthNorway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616837
- Sponsor's protocol ID
- P-REK-N-134/2006
- Other IDs
- Personvernombudet,UNN 05.12.06, P-REK-N-134/2006 (REK)
- Status last verified
- Dec 2015
- First submitted
- 22 Jan 2008
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Buvik A, Bergmo TS, Bugge E, Smaabrekke A, Wilsgaard T, Olsen JA. Cost-Effectiveness of Telemedicine in Remote Orthopedic Consultations: Randomized Controlled Trial. J Med Internet Res. 2019 Feb 19;21(2):e11330. doi: 10.2196/11330.
PubMed 30777845Buvik A, Bugge E, Knutsen G, Smabrekke A, Wilsgaard T. Quality of care for remote orthopaedic consultations using telemedicine: a randomised controlled trial. BMC Health Serv Res. 2016 Sep 8;16(1):483. doi: 10.1186/s12913-016-1717-7.
PubMed 27608768
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Orthopedic Outpatient Consultation by Help of Telemedicine
- ClinicalTrials.gov ID
- NCT00616837
- Acronym / sponsor ID
- P-REK-N-134/2006
- Conditions
- Orthopedic Disorders
- Keywords
- Remote consultation/*methods, Orthopaedics methods, Telemedicine, Follow-up study, Ambulatory care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord
- Study start
- Nov 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Feb 2008 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard consultation | Active comparator | Other: Standard care in orthopaedic outpatient clinicStandard care in orthopaedic outpatient clinic |
| Telemedicine consultation | Experimental | Other: Telemedicine consultationOrthopaedic care in outpatient clinic by use of telemedicine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Telemedicine consultationOutpatient consultation by help of telemedicine (video conference) | Other | Telemedicine consultation |
| Standard care in orthopaedic outpatient clinicStandard care in orthopedic outpatient clinic (usual care) | Other | Standard consultation |
Primary outcome
Safety and quality of health care
Time frame: 1 year
2 secondary outcomes
Patient satisfaction
Time frame: up to 1 year after last consultation
Cost value
Time frame: up to 1 year
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 17 Dec 2015.
- Derived from this study: PubMed 30777845Buvik A, Bergmo TS, Bugge E, Smaabrekke A, Wilsgaard T, Olsen JA. Cost-Effectiveness of Telemedicine in Remote Orthopedic Consultations: Randomized Controlled Trial. J Med Internet Res. 2019 Feb 19;21(2):e11330. doi: 10.2196/11330.
- Derived from this study: PubMed 27608768Buvik A, Bugge E, Knutsen G, Smabrekke A, Wilsgaard T. Quality of care for remote orthopaedic consultations using telemedicine: a randomised controlled trial. BMC Health Serv Res. 2016 Sep 8;16(1):483. doi: 10.1186/s12913-016-1717-7.
Related trials for Orthopedic Disorders
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
Astrid S Buvik, MD principal investigator
University Hospital North Norway
Arvid Smaabrekke, MD study chair
University Hospital North Norway
Jan Abel Olsen, PhD study chair
University of Tromso
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 consultation in people with Orthopedic Disorders, run by University Hospital of North Norway at 1 site in Norway.
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 5 inclusion and 5 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 17 Dec 2015. 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 Norway. 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?
Safety and quality of health care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00616837, which also lists 2 linked publications.
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 17 Dec 2015.