Inflammatory ArthritisNCT02371915
Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis
A study testing Videoconference follow-up in people with Inflammatory Arthritis, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This project will be conducted in two phases. Phase 1: RA patients will be recruited to participate in five repeated examinations occurring in one day to compare between and within specialties, ensuring reasonable equivalency of examination findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- Videoconference follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will include participation in the earlier validation study (Part A).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models
This project will be conducted in two phases. Phase 1: RA patients will be recruited to participate in five repeated examinations occurring in one day to compare between and within specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients living > 100 km from Saskatoon will be randomized to the intervention or control group, with both groups having three follow-up appointments in 3-month intervals. The intervention group will be evaluated by a physiotherapist supported by a rheumatologist through videoconferencing, while the control group will continue to travel to Saskatoon for follow-up care.
Read the 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.
- Conditions
- Inflammatory Arthritis
- Being tested
- Videoconference follow-up
- Keywords
- Rural access, Telehealth
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoconference follow-upOther
Rheumatology visits to take place video videoconference with a physiotherapist present
| Study group | Role | What they receive |
|---|---|---|
| Videoconference follow-up | Experimental | 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. Receives: Other: Videoconference follow-up |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score-28 (DAS-28)
Measured: at 3 month intervals over nine months
Secondary outcomes (7)
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Measured: at 3 month intervals over nine months
Change in Epworth Sleepiness Scale
Measured: at 3 month intervals over nine months
Change in Healthcare Use
Measured: at 3 month intervals over nine months
Change in Modified Health Assessment Questionnaire (MHAQ)
Measured: at 3 month intervals over nine months
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: at 3 month intervals over nine months
Change in International Physical Activity Questionnaire (IPAQ)
Measured: at 3 month intervals over nine months
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Measured: at 3 month intervals over nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Responsible party
- Principal investigator, Regina M. Taylor-Gjevre, University of Saskatchewan
- Investigators
- Regina Taylor-Gjevre, MD, Principal investigator, Univsersity of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371915
- Sponsor's protocol ID
- 14-176
- Status last verified
- Oct 2016
- First submitted
- 8 Dec 2014
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models
- ClinicalTrials.gov ID
- NCT02371915
- Acronym / sponsor ID
- 14-176
- Conditions
- Inflammatory Arthritis
- Keywords
- Rural access, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Initiative for Outcomes in Rheumatology Care
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2015 (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.
This project will be conducted in two phases. Phase 1: RA patients will be recruited to participate in five repeated examinations occurring in one day to compare between and within specialties, ensuring reasonable equivalency of examination findings. Phase 2: RA patients living > 100 km from Saskatoon will be randomized to the intervention or control group, with both groups having three follow-up appointments in 3-month intervals. The intervention group will be evaluated by a physiotherapist supported by a rheumatologist through videoconferencing, while the control group will continue to travel to Saskatoon for follow-up care.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoconference follow-up | Experimental | Other: Videoconference follow-upThese 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. |
| Control | No intervention | –These subjects will continue to travel into Saskatoon for the rheumatology visits, as they normally would for routine follow-up visits with their rheumatologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion criteria will include participation in the earlier validation study (Part A).
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 |
|---|---|---|
| Videoconference follow-upRheumatology visits to take place video videoconference with a physiotherapist present | Other | Videoconference follow-up |
Primary outcome
Change in Disease Activity Score-28 (DAS-28)
Time frame: at 3 month intervals over nine months
7 secondary outcomes
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Time frame: at 3 month intervals over nine months
Change in Epworth Sleepiness Scale
Time frame: at 3 month intervals over nine months
Change in Healthcare Use
Time frame: at 3 month intervals over nine months
Change in Modified Health Assessment Questionnaire (MHAQ)
Time frame: 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
Change in International Physical Activity Questionnaire (IPAQ)
Time frame: at 3 month intervals over nine months
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Time frame: at 3 month intervals over nine months
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 26 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Regina Taylor-Gjevre, MD principal investigator
Univsersity of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoconference follow-up in people with Inflammatory Arthritis, run by University of Saskatchewan at 1 site in Canada.
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 2 inclusion and 1 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 26 Oct 2016. 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 Canada. 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?
Change in Disease Activity Score-28 (DAS-28) (time frame: at 3 month intervals over nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.