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OpenTrials
Completed

NCT Number: NCT02371915

Interprofessional Care Models Using Videoconferencing for Patients With Inflammatory Arthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Videoconference follow-up

Other

Rheumatology visits to take place video videoconference with a physiotherapist present

Primary outcomes

  1. Change in Disease Activity Score-28 (DAS-28)

    Time frame: at 3 month intervals over nine months

Secondary outcomes

  1. Change in European Quality of Life - 5 Dimensions(EQ-5D)

    Time frame: at 3 month intervals over nine months

  2. Change in Epworth Sleepiness Scale

    Time frame: at 3 month intervals over nine months

  3. Change in Healthcare Use

    Time frame: at 3 month intervals over nine months

  4. Change in Modified Health Assessment Questionnaire (MHAQ)

    Time frame: at 3 month intervals over nine months

  5. Change in Work Productivity and Activity Impairment Questionnaire (WPAI)

    Time frame: at 3 month intervals over nine months

  6. Change in International Physical Activity Questionnaire (IPAQ)

    Time frame: at 3 month intervals over nine months

  7. Change in Rheumatoid Arthritis Disease Activity Index (RADAI)

    Time frame: at 3 month intervals over nine months

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Canadian Initiative for Outcomes in Rheumatology Care

Registry information

Official study title

Addressing Rural and Remote Access Disparities for Patients With Inflammatory Arthritis Through Telehealth/Videoconferencing and Innovative Inter-professional Care Models

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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