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

Migraine Clinical Trial

— TeII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05278325
• Other study ID #: H18008942
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: October 5, 2021

Study information

• Verified date: March 2022
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: October 5, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Tension-Type Headache

Intervention

Other:
• Telephone intervention
Two planned phone call between clinical controls

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in headache frequency	Difference in change of headache days per month between the two groups	From baseline to six months
Secondary	Change in migraine frequency	Difference in change of migraine days per month between the two groups	From baseline to six months
Secondary	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
Secondary	Change in Insomnia Severity Index (ISI) score	Difference in change in ISI score between the two groups	From baseline to six months
Secondary	Change in Hospitality Anxiety Depression Scale (HADS) score	Difference in change in HADS between the two groups	From baseline to six months
Secondary	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