- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078012
Short Intervention for Medication Overuse Headache (MOH) - Pilot (SIMOHpilot)
Pilot Study of Short Intervention for Medication Overuse Headache in General Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The present pilot study focuses on testing the logistics and the methodology of short intervention on a pilot group of GPs and their patients.
Due to low recruitment and the pilot study focus on logistics and methodology, the study was changed to not include a control (business as usual) arm. The outcomes were evaluated as "before - after" data and qualitative comments on acceptability and utility of the method. Primary outcomes were changed to be the acceptability and utility (previously listed as secondary outcomes) while secondary outcomes were headache days and medication days (previously listed as primary).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oslo, Norway, 0318
- Department of General Practice and Community Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with medication overuse headache
Exclusion Criteria:
- Other complicating pain condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Trained counselling
Comparison of outcomes before intervention vs. 2 months after
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative comments of participants on acceptability and utility
Time Frame: 2 months
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative comments of participants on acceptability and utility.
Time Frame: 2 months
|
2 months
|
Number of medication days per month
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIMOH pilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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