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临床试验/NCT02371915
NCT02371915已完成不适用

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

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Change in Disease Activity Score-28 (DAS-28)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •Exclusion criteria will include participation in the earlier validation study (Part A).

研究组 & 干预措施

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.

干预措施: Videoconference follow-up (Other)

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.

结局指标

主要结局

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

时间窗: at 3 month intervals over nine months

次要结局

  • Change in Work Productivity and Activity Impairment Questionnaire (WPAI)(at 3 month intervals over nine months)
  • Change in International Physical Activity Questionnaire (IPAQ)(at 3 month intervals over nine months)
  • Change in European Quality of Life - 5 Dimensions(EQ-5D)(at 3 month intervals over nine months)
  • Change in Epworth Sleepiness Scale(at 3 month intervals over nine months)
  • Change in Healthcare Use(at 3 month intervals over nine months)
  • Change in Modified Health Assessment Questionnaire (MHAQ)(at 3 month intervals over nine months)
  • Change in Rheumatoid Arthritis Disease Activity Index (RADAI)(at 3 month intervals over nine months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Regina M. Taylor-Gjevre

Professor of Medicine

University of Saskatchewan

研究点 (1)

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