- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02960269
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
October 10, 2018 updated by: Brenna Bath, University of Saskatchewan
This pilot study will evaluate the impact and overall experience of an interprofessional chronic low back pain patient care approach for people in rural and remote areas using Telehealth technology compared to secure laptop based videoconferencing (Vidyo).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
People with chronic low back pain will be recruited to participate in a team assessment with a local rural nurse practitioner and an-urban based physiotherapist linking through telehealth.
The assessment will include a detailed history, physical examination and jointly-delivered education and recommendations for further community-based management.
Pre and post measures of self-reported pain, back-specific function, quality of life, and satisfaction will be completed 2-4 weeks after the assessment.
Comparison of short-term outcomes will be made with a group of participants from another study using the a different telehealth technology (secure laptop based videoconferencing) same inclusion criteria, measures and health care providers (Clin Trials.gov
NCT02225535).
The health care providers will be interviewed to get feedback on their preference and experience using the different type of telehealth technology.
Study Type
Interventional
Enrollment (Actual)
12
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
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 0W3
- University of Saskatchewan
-
-
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
chronic low back pain localized below costal margins and above gluteal folds and/or related leg pain, which is bad enough to limit their usual activities or daily routine and has been present for at least 3 months
Exclusion Criteria:
- People with: third party payer insurance (i.e.worker's compensation board) for their back related complaints, with primarily neck or thoracic pain, and/ or with language, reading or comprehension barriers that would limit their ability to adequately complete the required study paperwork will be excluded from participating in the study.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telehealth team assessment
Team assessment for back pain with nurse practitioner and physical therapist via telehealth
|
team assessment and education with urban physical therapist and rural nurse practitioner via telehealth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient experience with telehealth
Time Frame: 2-4 weeks after assessment
|
2-4 weeks after assessment
|
|
Pain
Time Frame: 2-4 weeks after assessment
|
Numeric Pain Rating Scale
|
2-4 weeks after assessment
|
Back-specific function
Time Frame: 2-4 weeks after assessment
|
Modified Oswestry Disability Index
|
2-4 weeks after assessment
|
Participant satisfaction
Time Frame: 2-4 weeks after assessment
|
Modified VSQ-9
|
2-4 weeks after assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care provider experience
Time Frame: within 2 weeks of completion of all assessments
|
experience with telehealth technology
|
within 2 weeks of completion of all assessments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
November 7, 2016
First Submitted That Met QC Criteria
November 7, 2016
First Posted (Estimate)
November 9, 2016
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bio16-49
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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