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

December 29, 2015 updated by: Christofer Lundqvist, University Hospital, Akershus

Pilot Study of Short Intervention for Medication Overuse Headache in General Practice

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".

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0318
        • Department of General Practice and Community Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with medication overuse headache

Exclusion Criteria:

  • Other complicating pain condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Trained counselling

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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

December 1, 2015

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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