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Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis

25. oktober 2016 oppdatert av: Regina M. Taylor-Gjevre, University of Saskatchewan

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.

Studieoversikt

Status

Fullført

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:

  1. Rheumatologist A. to Rheumatologist B.
  2. Physiotherapist A. to Physiotherapist B.
  3. 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

Intervensjonell

Registrering (Faktiske)

85

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • University of Saskatchewan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
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.
Rheumatology visits to take place video videoconference with a physiotherapist present
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change in Disease Activity Score-28 (DAS-28)
Tidsramme: at 3 month intervals over nine months
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
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
at 3 month intervals over nine months
Change in International Physical Activity Questionnaire (IPAQ)
Tidsramme: at 3 month intervals over nine months
at 3 month intervals over nine months
Change in Rheumatoid Arthritis Disease Activity Index (RADAI)
Tidsramme: at 3 month intervals over nine months
at 3 month intervals over nine months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Regina Taylor-Gjevre, MD, Univsersity of Saskatchewan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2014

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. august 2016

Datoer for studieregistrering

Først innsendt

8. desember 2014

Først innsendt som oppfylte QC-kriteriene

19. februar 2015

Først lagt ut (Anslag)

26. februar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. oktober 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. oktober 2016

Sist bekreftet

1. oktober 2016

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)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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