Short Intervention for Medication Overuse Headache (MOH)... | NCT01078012

Studies
Short Intervention for Medication Overuse Headache (MOH) - Pilot

NCT01078012

Sponsor

University Hospital, Akershus

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

5Actual

Phase

Not Applicable

Conditions

Medication Overuse Headache

Interventions

Trained counselling

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Mar 1, 2010

First Submission Date that Met QC Criteria

Mar 1, 2010

First Posted Date

Mar 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christofer Lundqvist, Principal Investigator, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

University Hospital, AkershusOTHER

Collaborators

Name	Class
Department of General Practice and Community Medicine, Oslo	UNKNOWN
Head and Neck Research Group, Lørenskog	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate whether training of GPs in the detection and treatment of medication overuse headache leads to improved care for these patients as compared to "business as usual".

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trained counselling	Active Comparator	Comparison of outcomes before intervention vs. 2 months after	Behavioral: Trained counselling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trained counselling	Behavioral		Trained counselling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative comments of participants on acceptability and utility		2 months

Secondary Outcomes

Measure	Description	Time Frame
Qualitative comments of participants on acceptability and utility.		2 months
Number of medication days per month		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with medication overuse headache

Exclusion Criteria:

Other complicating pain condition

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of General Practice and Community Medicine		Oslo	Oslo	0318	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24646429	Derived	Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Feasibility of a brief intervention for medication-overuse headache in primary care--a pilot study. BMC Res Notes. 2014 Mar 20;7:165. doi: 10.1186/1756-0500-7-165.

ID	Term
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases