- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02371915
Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis
Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Part A: Validation Study This study involves inter-professional care with rural-based physical therapists and urban-based rheumatologists, it will be a valuable first step to validate comparability of the physical examination. We shall compare physical examination accuracy between and within examiner disciplines. Examiners will include the three rheumatologist study investigators and three participating physical therapists with additional training in inflammatory rheumatic diseases and experienced in musculoskeletal assessment.
Procedures: All examiners will undergo a standardized review of examination techniques and documentation prior to participating.
Comparison groups will be:
- Rheumatologist A. to Rheumatologist B.
- Physiotherapist A. to Physiotherapist B.
- Rheumatologist A/B to Physiotherapist C/teleconferenced Rheumatologist C. We will use web-based videoconferencing software. This desktop-based solution is currently being piloted by Telehealth Saskatchewan and is used extensively in Ontario. This technology satisfies Health Information Protection Act (HIPA) as well as the Saskatchewan privacy and security concerns. An examining room with telehealth/videoconference equipment will be available for patient distance examination for comparison group C as listed above. The rheumatologist will be in a physically separate room with viewing equipment in a mock distance evaluation. The proposed study will be conducted in cooperation with the Canadian Centre for Health and Safety in Agriculture (CCHSA) within the ≈1350 m2 National Agricultural-Industrial Hygiene Laboratory. Clinical visits will be conducted at the CCHSA.
Part B: Randomized Controlled Rheumatoid Arthritis Care Delivery Model Trial Randomization: Participating patients will be randomly allocated to two arms, either to be followed by telehealth/videoconferencing in or near their home community or to continue traveling to their Saskatoon rheumatology clinic.
Intervention: One study arm will be followed in traditional rheumatology clinic (in-person examining rheumatologist). The second study arm will be followed by telehealth/videoconferencing. Patients in the telehealth/videoconferencing arm will be examined by a rural-based physical therapist who will report exam findings during telehealth review with the urban-based rheumatologist. Follow-up visits will be every three months in both arms. All patients will complete standardized history/data-collection forms. Patients will be followed in their respective study arms for nine months, and then will be evaluated in-person in rheumatology clinic for final face-to-face disease activity evaluation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada
- University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Part A: Patients with established rheumatologist diagnosed RA attending rheumatology clinic at Royal University Hospital, (Saskatoon) and providing informed consent, will be recruited.
Part B: As the target population for future telehealth/VC utilization will be patients living outside the urban centers, participants will be similarly selected. Inclusion criteria will be: age over 18 years, ability to provide informed consent, place of residence 100 kilometers or more outside of Saskatoon, and rheumatologist established diagnosis of rheumatoid arthritis.
Exclusion Criteria:
Exclusion criteria will include participation in the earlier validation study (Part A).
Study Plan
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 |
|---|---|
|
Experimental: Videoconference follow-up
These subjects will remain in or near their home communities for rheumatology follow-up visits.
Follow-up visits will occur via telehealth/videoconferencing, with a physiotherapist present, performing the in-person assessment, supported by the rheumatologist via videoconference.
|
Rheumatology visits to take place video videoconference with a physiotherapist present
|
|
No Intervention: Control
These subjects will continue to travel into Saskatoon for the rheumatology visits, as they normally would for routine follow-up visits with their rheumatologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Disease Activity Score-28 (DAS-28)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Epworth Sleepiness Scale
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Healthcare Use
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Modified Health Assessment Questionnaire (MHAQ)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in International Physical Activity Questionnaire (IPAQ)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Time Frame: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Inflammatory Arthritis
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Assiut UniversityNot yet recruitingSubtalar Osteoarthritis Secondary to Inflammatory Arthritis
-
Mayo ClinicGE HealthcareRecruitingInflammatory ArthritisUnited States
-
Sunnybrook Health Sciences CentreUniversity of British ColumbiaActive, not recruiting
-
McMaster UniversityUnknown
-
Dorothy House HospiceUniversity Hospitals Bristol and Weston NHS Foundation Trust; University of... and other collaboratorsRecruitingInflammatory Arthritis | Palliative CareUnited Kingdom
-
Guy's and St Thomas' NHS Foundation TrustNot yet recruitingInflammatory Arthritis
-
University of LeedsTerminatedInflammatory ArthritisUnited Kingdom
-
University of LorraineWithdrawn
Clinical Trials on Videoconference follow-up
-
Istanbul University - Cerrahpasa (IUC)CompletedInfertility | Psychological Distress | Infertility, Female | Depression, Anxiety | Nurse's RoleTurkey
-
M.D. Anderson Cancer CenterCompletedRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Connolly Hospital BlanchardstownCompletedGeneral Surgery | Outpatients | Virtual Clinic | Text MessagingIreland
-
Centre Hospitalier Universitaire DijonRecruiting
-
Sport Injury Prevention Research CentreGeneral Electric; National Basketball AssociationCompletedTendinopathy | Sports Injuries in Children | Injury, Knee | Injury, AnkleCanada
-
Poitiers University HospitalNot yet recruiting
-
Rennes University HospitalUnknown
-
Fondation Ophtalmologique Adolphe de RothschildRecruiting
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Trialbureau... and other collaboratorsRecruitingAdolescent Idiopathic ScoliosisNetherlands
-
Centre Hospitalier Universitaire, AmiensActive, not recruitingQuality of Life | Pain | Lumbar Spine SurgeryFrance