Self-help and Education on the Internet for Functional Motor Disorders (SHIFT)
Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
調査の概要
詳細な説明
Patients will be referred to the study from all neurology centers in the Netherlands that are found willing to participate. After informed consent is acquired, patients will be randomised into one of these two groups: usual care only or the education and self help intervention added to usual care. At baseline, after 3 months and after 6 months patients will fill out questionnaires at home online or on paper.
Patients will not be blinded for the intervention. The researcher is blinded during analysis of the data. During the study contact between the researcher and the participants will be restricted to research related topics. All contact between participants and the researcher will be documented.
To increase generalisability and applicability in clinical practice after the trial the investigators have chosen to add the intervention to usual care and to keep exclusion criteria to a minimum.
Our education and self help internet intervention is an especially designed website with an educational approach. The content of the intervention is written by a team of international experts and consists of education about the mechanism of functional motor disorders and it's treatment and of self help advice and exercises. During the trial the website will only be accessible with a log-in. The education and self help internet intervention is self-explanatory and unguided.
The medical ethical committee of the University Medical Center Groningen has taken our research under review and has decided this study does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO-Wet Mensgebonden Onderzoek).
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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Groningen、オランダ、9700 RB
- University Medical Center Groningen
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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:
- Diagnosis of functional motor symptom from a neurologist
- The motor symptom(s) cause(s) distress or impairment in social, occupational or other important areas of functioning.
- Able to read Dutch
- Access to a computer with internet connection on a regular basis
Exclusion Criteria:
- Incapacitated (Not able to provide informed consent)
- Accidental finding of a motor symptom in a patient with other (functional) complaints.
- Known existing visitor of the (previously available, but currently offline) translated version of a website by Dr. Jon Stone
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：intervention
This arm will receive the education and self-help internet intervention added to usual care
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The intervention is a newly developed website which consists of information about the mechanism and treatment of functional motor disorders.
Furthermore self-help elements like exercises to perform at home and rehabilitation advice are added.
The intervention is unguided.
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介入なし：control
This arm will receive usual care only
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Subjective general health Status on the Clinical Global Improvement scale
時間枠：3 months
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CGI, self-rated, 7-point scale of general health status
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3 months
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Subjective general health Status on the Clinical Global Improvement scale
時間枠：6 months
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CGI self-rated, 7-point scale of general health status
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life on domains of RAND-36
時間枠：3 months
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extra question added to RAND-36 from WHOQuality Of Life scale
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3 months
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Quality of life on domains of RAND-36
時間枠：6 months
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extra question added to RAND-36 from WHO-Quality Of Life scale
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6 months
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Illness beliefs on the Illness Perception Questionnaire
時間枠：3 months
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Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
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3 months
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Illness beliefs on the Illness Perception Questionnaire
時間枠：6 months
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Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
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6 months
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Referral and other treatments on a questionnaire about referral and other treatments
時間枠：6 months
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Questions about future and past referrals to treatment
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6 months
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Symptom severity on the change in presenting symptoms scale
時間枠：3 months
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3 months
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Symptom severity on the change in presenting symptoms scale
時間枠：6 months
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6 months
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Work and social adjustment
時間枠：6 months
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Work and Social Adjustment scale
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6 months
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Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
時間枠：6 months
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Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
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6 months
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Patient satisfaction with general care and the study intervention
時間枠：3 months
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Questions on satisfaction with general care and with the education and selfhelp intervention in particular
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3 months
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Patient satisfaction with general care and the study intervention
時間枠：6 months
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Questions on satisfaction with general care and with the education and selfhelp intervention in particular
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6 months
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Psychiatric outcome on the Patient Health Questionnaire
時間枠：6 months
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6 months
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Fatigue on CIS-fatigue scale
時間枠：6 months
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6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Adverse events
時間枠：6 months
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Death and hospitalization during the trial
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6 months
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協力者と研究者
捜査官
- 主任研究者：Marina Tijssen, MD, PhD、University Medical Center Groningen, University of Groningen
出版物と役立つリンク
一般刊行物
- Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A. Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial. Neurology. 2011 Aug 9;77(6):564-72. doi: 10.1212/WNL.0b013e318228c0c7. Epub 2011 Jul 27.
- Lehn A, Gelauff J, Hoeritzauer I, Ludwig L, McWhirter L, Williams S, Gardiner P, Carson A, Stone J. Functional neurological disorders: mechanisms and treatment. J Neurol. 2016 Mar;263(3):611-20. doi: 10.1007/s00415-015-7893-2. Epub 2015 Sep 26.
- Stone J, Carson A. Functional neurologic disorders. Continuum (Minneap Minn). 2015 Jun;21(3 Behavioral Neurology and Neuropsychiatry):818-37. doi: 10.1212/01.CON.0000466669.02477.45.
- Gelauff JM, Dreissen YE, Tijssen MA, Stone J. Treatment of functional motor disorders. Curr Treat Options Neurol. 2014 Apr;16(4):286. doi: 10.1007/s11940-014-0286-5.
- Gelauff JM, Rosmalen JGM, Carson A, Dijk JM, Ekkel M, Nielsen G, Stone J, Tijssen MAJ. Internet-based self-help randomized trial for motor functional neurologic disorder (SHIFT). Neurology. 2020 Sep 29;95(13):e1883-e1896. doi: 10.1212/WNL.0000000000010381. Epub 2020 Jul 20.
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 (実際)
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
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