NCT01078012

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

March 1, 2010

Last Update Submit

December 29, 2015

Conditions

Medication Overuse Headache

Outcome Measures

Primary Outcomes (1)

  • Qualitative comments of participants on acceptability and utility

    2 months

Secondary Outcomes (2)

  • Qualitative comments of participants on acceptability and utility.

    2 months

  • Number of medication days per month

    2 months

Study Arms (1)

Trained counselling

ACTIVE COMPARATOR

Comparison of outcomes before intervention vs. 2 months after

Behavioral: Trained counselling

Interventions

Trained counsellingBEHAVIORAL
Trained counselling

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with medication overuse headache

You may not qualify if:

  • Other complicating pain condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Practice and Community Medicine

Oslo, Oslo County, 0318, Norway

Location

Related Publications (1)

  • 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.

    PMID: 24646429DERIVED

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

NO(1)