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

Study Overview
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Brief Summary
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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.

Official Title
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Improved Treatment Course for Patients With Migraine and Tension-type Headache

Conditions
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Migraine, Tension-Type Headache

Intervention / Treatment
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* Other: Telephone intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telephone Intervention<br>Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment | Other: Telephone intervention<br>* Two planned phone call between clinical controls<br>|
| No Intervention: Business as usual<br>No planned phone calls | |

What is the study measuring?
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Primary Outcome Measures

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