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

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: Migraine; Tension-Type Headache
• Intervention / Treatment: Other: Telephone intervention

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Study Chair: Henrik W Schytz, Ass Prof, Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme

Study record dates

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: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Tension-Type Headache
• 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