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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ
- University of Saskatchewan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Change in Disease Activity Score-28 (DAS-28)
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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二次結果の測定
結果測定 |
時間枠 |
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Change in European Quality of Life - 5 Dimensions(EQ-5D)
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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Change in Epworth Sleepiness Scale
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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Change in Healthcare Use
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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Change in Modified Health Assessment Questionnaire (MHAQ)
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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Change in Work Productivity and Activity Impairment Questionnaire (WPAI)
時間枠: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)
時間枠: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)
時間枠:at 3 month intervals over nine months
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at 3 month intervals over nine months
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協力者と研究者
捜査官
- 主任研究者:Regina Taylor-Gjevre, MD、Univsersity of Saskatchewan
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Videoconference follow-upの臨床試験
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了
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Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)積極的、募集していない
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University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical Research Center; Oregon Research Institute と他の協力者募集
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Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)積極的、募集していない
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VA Puget Sound Health Care System募集
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Rigshospitalet, DenmarkKing's College London; Deakin University積極的、募集していない