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

Primary Purpose

Migraine, Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telephone intervention
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone Intervention

Business as usual

Arm Description

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

No planned phone calls

Outcomes

Primary Outcome Measures

Change in preventive headache medication
Difference in number of patients with change in preventive headache medication in the two groups
Change in acute headache medication
Difference in number of patients with change in acute headache medication in the two groups

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2022
Last Updated
March 3, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT05278325
Brief Title
Improved Treatment Course for Patients With Migraine and Tension-type Headache
Acronym
TeII
Official Title
Improved Treatment Course for Patients With Migraine and Tension-type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Tension-Type Headache

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone Intervention
Arm Type
Experimental
Arm Description
Two planned phone call by health care professionals after 8 and 16 weeks adjusting acute and preventive treatment
Arm Title
Business as usual
Arm Type
No Intervention
Arm Description
No planned phone calls
Intervention Type
Other
Intervention Name(s)
Telephone intervention
Intervention Description
Two planned phone call between clinical controls
Primary Outcome Measure Information:
Title
Change in preventive headache medication
Description
Difference in number of patients with change in preventive headache medication in the two groups
Time Frame
From baseline to six months
Title
Change in acute headache medication
Description
Difference in number of patients with change in acute headache medication in the two groups
Time Frame
From baseline to six months
Secondary Outcome Measure Information:
Title
Change in headache frequency
Description
Difference in change of headache days per month between the two groups
Time Frame
From baseline to six months
Title
Change in migraine frequency
Description
Difference in change of migraine days per month between the two groups
Time Frame
From baseline to six months
Title
Change in Headache Under response to Treatment (HURT-8) score
Description
Difference in change in HURT-8 scale between the two groups
Time Frame
From baseline to six months
Title
Change in Insomnia Severity Index (ISI) score
Description
Difference in change in ISI score between the two groups
Time Frame
From baseline to six months
Title
Change in Hospitality Anxiety Depression Scale (HADS) score
Description
Difference in change in HADS between the two groups
Time Frame
From baseline to six months
Title
Change in patient satisfaction score
Description
Difference in change in patient satisfaction score (five questions focusing on treatment course) between the two groups
Time Frame
At six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik W Schytz, Ass Prof
Organizational Affiliation
Rigshospitalet-Glostrup, Afdeling for Hjerne- og Nervesygdomme
Official's Role
Study Chair
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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