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)
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Groningen, 네덜란드, 9700 RB
- University Medical Center Groningen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 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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간섭 없음: control
This arm will receive usual care only
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Subjective general health Status on the Clinical Global Improvement scale
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Quality of life on domains of RAND-36
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 3 months
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3 months
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Symptom severity on the change in presenting symptoms scale
기간: 6 months
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6 months
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Work and social adjustment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 6 months
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6 months
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Fatigue on CIS-fatigue scale
기간: 6 months
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6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse events
기간: 6 months
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Death and hospitalization during the trial
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marina Tijssen, MD, PhD, University Medical Center Groningen, University of Groningen
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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기능적 운동 장애에 대한 임상 시험
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Thammasat UniversityNational Research Council of Thailand완전한2세에서 10세 사이의 경련성 마비가 있는 어린이 | GMFCS(Gross Motor Function Classification System) 레벨 I, II 및 III태국
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