- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Kanada
- University of Saskatchewan
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
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Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in Disease Activity Score-28 (DAS-28)
Tidsram: at 3 month intervals over nine months
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at 3 month intervals over nine months
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Epworth Sleepiness Scale
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Healthcare Use
Tidsram: at 3 month intervals over nine months
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at 3 month intervals over nine months
|
Change in Modified Health Assessment Questionnaire (MHAQ)
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in International Physical Activity Questionnaire (IPAQ)
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Tidsram: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 14-176
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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