Self-help and Education on the Internet for Functional Motor Disorders (SHIFT)
Primary Purpose
Functional Motor Disorder
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Education and self-help internet intervention
Sponsored by
About this trial
This is an interventional treatment trial for Functional Motor Disorder focused on measuring Self-help, Education, e-Health
Eligibility Criteria
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
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
intervention
control
Arm Description
This arm will receive the education and self-help internet intervention added to usual care
This arm will receive usual care only
Outcomes
Primary Outcome Measures
Subjective general health Status on the Clinical Global Improvement scale
CGI, self-rated, 7-point scale of general health status
Subjective general health Status on the Clinical Global Improvement scale
CGI self-rated, 7-point scale of general health status
Secondary Outcome Measures
Quality of life on domains of RAND-36
extra question added to RAND-36 from WHOQuality Of Life scale
Quality of life on domains of RAND-36
extra question added to RAND-36 from WHO-Quality Of Life scale
Illness beliefs on the Illness Perception Questionnaire
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Illness beliefs on the Illness Perception Questionnaire
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Referral and other treatments on a questionnaire about referral and other treatments
Questions about future and past referrals to treatment
Symptom severity on the change in presenting symptoms scale
Symptom severity on the change in presenting symptoms scale
Work and social adjustment
Work and Social Adjustment scale
Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
Patient satisfaction with general care and the study intervention
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Patient satisfaction with general care and the study intervention
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Psychiatric outcome on the Patient Health Questionnaire
Fatigue on CIS-fatigue scale
Full Information
NCT ID
NCT02589886
First Posted
October 2, 2015
Last Updated
January 28, 2019
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02589886
Brief Title
Self-help and Education on the Internet for Functional Motor Disorders
Acronym
SHIFT
Official Title
Self-Help and Education on the Internet for Functional Motor Disorders, a Randomised Controlled Trial (SHIFT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomised trial to the effect of a newly developed education and self help intervention for patients with a functional motor disorder on general health, quality of life, illness perception, symptom severity and other secondary outcome measures.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Motor Disorder
Keywords
Self-help, Education, e-Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
This arm will receive the education and self-help internet intervention added to usual care
Arm Title
control
Arm Type
No Intervention
Arm Description
This arm will receive usual care only
Intervention Type
Other
Intervention Name(s)
Education and self-help internet intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective general health Status on the Clinical Global Improvement scale
Description
CGI, self-rated, 7-point scale of general health status
Time Frame
3 months
Title
Subjective general health Status on the Clinical Global Improvement scale
Description
CGI self-rated, 7-point scale of general health status
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life on domains of RAND-36
Description
extra question added to RAND-36 from WHOQuality Of Life scale
Time Frame
3 months
Title
Quality of life on domains of RAND-36
Description
extra question added to RAND-36 from WHO-Quality Of Life scale
Time Frame
6 months
Title
Illness beliefs on the Illness Perception Questionnaire
Description
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Time Frame
3 months
Title
Illness beliefs on the Illness Perception Questionnaire
Description
Questions from the Illness Perception Questionnaire and newly devised questions about beliefs and understanding of functional motor disorders
Time Frame
6 months
Title
Referral and other treatments on a questionnaire about referral and other treatments
Description
Questions about future and past referrals to treatment
Time Frame
6 months
Title
Symptom severity on the change in presenting symptoms scale
Time Frame
3 months
Title
Symptom severity on the change in presenting symptoms scale
Time Frame
6 months
Title
Work and social adjustment
Description
Work and Social Adjustment scale
Time Frame
6 months
Title
Cost-effectivity in QALY's calculated by using the PCQ, MCQ and EQ5D
Description
Analysis using: Patient Costs Questionnaire, Medical Costs Questionnaire, and EQ5D
Time Frame
6 months
Title
Patient satisfaction with general care and the study intervention
Description
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Time Frame
3 months
Title
Patient satisfaction with general care and the study intervention
Description
Questions on satisfaction with general care and with the education and selfhelp intervention in particular
Time Frame
6 months
Title
Psychiatric outcome on the Patient Health Questionnaire
Time Frame
6 months
Title
Fatigue on CIS-fatigue scale
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Death and hospitalization during the trial
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Tijssen, MD, PhD
Organizational Affiliation
University Medical Center Groningen, University of Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21795652
Citation
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.
Results Reference
background
PubMed Identifier
26410744
Citation
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.
Results Reference
background
PubMed Identifier
26039857
Citation
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.
Results Reference
background
PubMed Identifier
24566832
Citation
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.
Results Reference
background
PubMed Identifier
32690783
Citation
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.
Results Reference
derived
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Self-help and Education on the Internet for Functional Motor Disorders
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