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

NCT05278325 | Completed

• 1 other identifier: H18008942
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Tension-Type Headache

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change in headache frequency

  From baseline to six months

• Change in migraine frequency

  From baseline to six months

• Change in Headache Under response to Treatment (HURT-8) score

  From baseline to six months

• Change in Insomnia Severity Index (ISI) score

  From baseline to six months

• Change in Hospitality Anxiety Depression Scale (HADS) score

  From baseline to six months

Study Arms (2)

Telephone Intervention

EXPERIMENTAL

Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment

Other: Telephone intervention

Business as usual

NO INTERVENTION

No planned phone calls

Interventions

Telephone intervention OTHER

Two planned phone call between clinical controls

Telephone Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine and/or tension-type headache

You may not qualify if:

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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders; Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Henrik W Schytz, Ass Prof

  Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 14, 2022
• Study Start: May 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 5, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)