Improved Treatment Course for Patients With Migraine and Tension-type Headache (TeII)

March 3, 2022 updated by: Louise Carlsen, Danish Headache Center

The purpose of the study is to improve treatment for newly referred patients with migraine and tension-type headache to the Danish Headache Center.

All patients will recieve an electronic questionnaire just before the first visit concerning their current and previous history of headache and headache treatment.

Half of them will enter a special telephone-intervention (TeII) program with two planned phone-calls after 8 and 16 weeks from first visit. The other half of patients will follow the normal follow-up program.

All patients will be seen by a headache specialist after 6 months and will be asked to fill in a follow-up electronic questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

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

  • Denmark
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, 2600
        • Danish Headache Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Migraine and/or tension-type headache

Exclusion Criteria:

  • Other headache diagnoses, including cluster headache, medication overuse-headache, other secondary headaches, trigeminal neuralgia.
  • Included in clinical trials at the DHC.

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telephone Intervention
Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment
Other: Telephone intervention
Two planned phone call between clinical controls
NO_INTERVENTION: Business as usual
No planned phone calls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in preventive headache medication
Time Frame: From baseline to six months
Difference in number of patients with change in preventive headache medication in the two groups
From baseline to six months
Change in acute headache medication
Time Frame: From baseline to six months
Difference in number of patients with change in acute headache medication in the two groups
From baseline to six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in headache frequency
Time Frame: From baseline to six months
Difference in change of headache days per month between the two groups
From baseline to six months
Change in migraine frequency
Time Frame: From baseline to six months
Difference in change of migraine days per month between the two groups
From baseline to six months
Change in Headache Under response to Treatment (HURT-8) score
Time Frame: From baseline to six months
Difference in change in HURT-8 scale between the two groups
From baseline to six months
Change in Insomnia Severity Index (ISI) score
Time Frame: From baseline to six months
Difference in change in ISI score between the two groups
From baseline to six months
Change in Hospitality Anxiety Depression Scale (HADS) score
Time Frame: From baseline to six months
Difference in change in HADS between the two groups
From baseline to six months
Change in patient satisfaction score
Time Frame: At six months
Difference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups
At six months

Collaborators and Investigators

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

Sponsor

Danish Headache Center

Investigators

  • Study Chair: Henrik W Schytz, Ass Prof, Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme

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 (ACTUAL)

May 1, 2020

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

October 5, 2021

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 3, 2022

First Posted (ACTUAL)

March 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18008942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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