- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- University of Saskatchewan
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Rheumatology visits to take place video videoconference with a physiotherapist present
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in Disease Activity Score-28 (DAS-28)
Tidsramme: at 3 month intervals over nine months
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at 3 month intervals over nine months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in European Quality of Life - 5 Dimensions(EQ-5D)
Tidsramme: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Epworth Sleepiness Scale
Tidsramme: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Healthcare Use
Tidsramme: 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)
Tidsramme: at 3 month intervals over nine months
|
at 3 month intervals over nine months
|
|
Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
Tidsramme: at 3 month intervals over nine months
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at 3 month intervals over nine months
|
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Change in International Physical Activity Questionnaire (IPAQ)
Tidsramme: at 3 month intervals over nine months
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at 3 month intervals over nine months
|
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Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Tidsramme: at 3 month intervals over nine months
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at 3 month intervals over nine months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 14-176
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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