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Digital-technology Based Interventions on Treatment of Migraine. (Migrevention)

Primary Purpose

Migraine, Primary Headache Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
digital platform
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. diagnosed migraine, frequent episodic, headache days a month 8-14 days;
  2. patient age 18-64 years;
  3. very good command of the Estonian language both orally and in writing.

Exclusion Criteria:

  1. headaches lasting less than 8 days and more than 14 days per month;
  2. all other primary and/or secondary diagnoses of headache;
  3. under the age of 18 or over 64;
  4. currently severe depression;
  5. psychotic disorders;
  6. pregnancy and lactation;
  7. severe somatic disease;
  8. severe organic mental disorders;
  9. other chronic pain;
  10. addictive disorders.

Sites / Locations

  • Tartu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1. Digital diary

2. Paper diary

3. Digital: diary and headache nurse

4. Paper diary and conventional headache nurse

5. Digital: diary, headache nurse and clinal psychologist

6. Paper diary, conventional headache nurse and conventional clinical psychologist

7. Digital: diary, headache nurse, clinal psychologist and physiotherapist

8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist

Arm Description

75 participants in the group

75 participants in the group

75 participants in the group

75 participants in the group

75 participants in the group

75 participants in the group

75 participants in the group

75 participants in the group

Outcomes

Primary Outcome Measures

headache frequency
headache diary: number of headache days per month
headache frequency
headache diary: number of headache days per month
headache frequency
headache diary: number of headache days per month

Secondary Outcome Measures

medication use
headache diary: number of headache days per month
medication use
headache diary: number of headache days per month
medication use
headache diary: number of headache days per month
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Health related quality of life
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Health related quality of life
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Health related quality of life
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Patient satisfaction with treatment 1
Headache Attributed Lost Time (HALT)
Patient satisfaction with treatment 2
Headache Under-Response to Treatment (HURT)
Patient satisfaction with treatment 3
Headache Attributed Lost Time (HALT)
Patient satisfaction with treatment 4
Headache Under-Response to Treatment (HURT)
Patient satisfaction with treatment 5
Headache Attributed Lost Time (HALT)
Patient satisfaction with treatment 6
Headache Under-Response to Treatment (HURT)
Cost-effectiveness 1
databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - sick leaves compensation)
Cost-effectiveness 2
databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - medications reimbursement)
Patient's willingness to pay for headache treatment
Willingness to pay bidding game

Full Information

First Posted
January 21, 2022
Last Updated
January 16, 2023
Sponsor
Tartu University Hospital
Collaborators
University of Tartu
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1. Study Identification

Unique Protocol Identification Number
NCT05458817
Brief Title
Digital-technology Based Interventions on Treatment of Migraine.
Acronym
Migrevention
Official Title
Digital-technology Based Interventions on Treatment of Migraine.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tartu University Hospital
Collaborators
University of Tartu

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 main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy).
Detailed Description
Aims and purpose: The main aim of the research: To develop an interdisciplinary treatment platform based on digital technology and test the operation and effectiveness of digital interventions in comparison with conventional multidisciplinary treatment or treatment standards (incl. Paper diary, nurse counseling, physiotherapy, cognitive-behavioral therapy). Sub-aims: To evaluate the effectiveness of interventions based on digital technology and their impact on the quality of life, comparing them with the interventions or treatment standards performed by ordinary specialists. Assess the applicability and accessibility of digital technology-based interventions in the healthcare system against a treatment standard. Determine the profile of patients (demographic and clinical indicators). Identify restrictions on the use of digital interventions. Evaluate patient compliance, non-specific treatment factors such as therapeutic relationship, and treatment credibility against the treatment standard. Evaluate patient satisfaction with treatment methods and impact on treatment outcomes. Assess the satisfaction of professionals with the implementation of a digital multidisciplinary treatment platform in patients. Assess the use and generalization of digitally acquired skills in everyday practice. Determine if and how much clinical contact is needed for digital-based interventions to be effective. Evaluate cost-effectiveness against the standard of treatment. Assess the willingness to pay for the use of an effective headache treatment platform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Primary Headache Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. Digital diary
Arm Type
Experimental
Arm Description
75 participants in the group
Arm Title
2. Paper diary
Arm Type
Active Comparator
Arm Description
75 participants in the group
Arm Title
3. Digital: diary and headache nurse
Arm Type
Experimental
Arm Description
75 participants in the group
Arm Title
4. Paper diary and conventional headache nurse
Arm Type
Active Comparator
Arm Description
75 participants in the group
Arm Title
5. Digital: diary, headache nurse and clinal psychologist
Arm Type
Experimental
Arm Description
75 participants in the group
Arm Title
6. Paper diary, conventional headache nurse and conventional clinical psychologist
Arm Type
Active Comparator
Arm Description
75 participants in the group
Arm Title
7. Digital: diary, headache nurse, clinal psychologist and physiotherapist
Arm Type
Experimental
Arm Description
75 participants in the group
Arm Title
8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist
Arm Type
Active Comparator
Arm Description
75 participants in the group
Intervention Type
Other
Intervention Name(s)
digital platform
Intervention Description
Patients in the digital group complete the tests in the patient's mobile application and/or in the Internet-based research environment of the Institute of Psychology of the University of Tartu kaemus.psych.ut.ee. Patients and specialists of the control group fill in the tests and the satisfaction questionnaire in the kaemus.psych.ut.ee environment.
Primary Outcome Measure Information:
Title
headache frequency
Description
headache diary: number of headache days per month
Time Frame
3 months
Title
headache frequency
Description
headache diary: number of headache days per month
Time Frame
6 months
Title
headache frequency
Description
headache diary: number of headache days per month
Time Frame
9 months
Secondary Outcome Measure Information:
Title
medication use
Description
headache diary: number of headache days per month
Time Frame
3 months
Title
medication use
Description
headache diary: number of headache days per month
Time Frame
6 months
Title
medication use
Description
headache diary: number of headache days per month
Time Frame
9 months
Title
The effect of headaches on everyday life
Description
Headache Impact Test (HIT-6)
Time Frame
3 months
Title
The effect of headaches on everyday life
Description
Headache Impact Test (HIT-6)
Time Frame
6 months
Title
The effect of headaches on everyday life
Description
Headache Impact Test (HIT-6)
Time Frame
9 months
Title
Pain acceptance Pain acceptance Pain acceptance
Description
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Time Frame
3 months
Title
Pain acceptance Pain acceptance Pain acceptance
Description
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Time Frame
6 months
Title
Pain acceptance Pain acceptance Pain acceptance
Description
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Time Frame
9 months
Title
Pain-related anxiety
Description
Pain Anxiety Symptoms Scale (PASS)
Time Frame
3 months
Title
Pain-related anxiety
Description
Pain Anxiety Symptoms Scale (PASS)
Time Frame
6 months
Title
Pain-related anxiety
Description
Pain Anxiety Symptoms Scale (PASS)
Time Frame
9 months
Title
Health related quality of life
Description
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Time Frame
3 months
Title
Health related quality of life
Description
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Time Frame
6 months
Title
Health related quality of life
Description
EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Time Frame
9 months
Title
Patient satisfaction with treatment 1
Description
Headache Attributed Lost Time (HALT)
Time Frame
3 months
Title
Patient satisfaction with treatment 2
Description
Headache Under-Response to Treatment (HURT)
Time Frame
3 months
Title
Patient satisfaction with treatment 3
Description
Headache Attributed Lost Time (HALT)
Time Frame
6 months
Title
Patient satisfaction with treatment 4
Description
Headache Under-Response to Treatment (HURT)
Time Frame
6 months
Title
Patient satisfaction with treatment 5
Description
Headache Attributed Lost Time (HALT)
Time Frame
9 months
Title
Patient satisfaction with treatment 6
Description
Headache Under-Response to Treatment (HURT)
Time Frame
9 months
Title
Cost-effectiveness 1
Description
databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - sick leaves compensation)
Time Frame
9 months
Title
Cost-effectiveness 2
Description
databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - medications reimbursement)
Time Frame
9 months
Title
Patient's willingness to pay for headache treatment
Description
Willingness to pay bidding game
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed migraine, frequent episodic, headache days a month 8-14 days; patient age 18-64 years; very good command of the Estonian language both orally and in writing. Exclusion Criteria: headaches lasting less than 8 days and more than 14 days per month; all other primary and/or secondary diagnoses of headache; under the age of 18 or over 64; currently severe depression; psychotic disorders; pregnancy and lactation; severe somatic disease; severe organic mental disorders; other chronic pain; addictive disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Braschinsky, MD, PhD
Phone
+3727318501
Email
mark.braschinsky@kliinikum.ee
First Name & Middle Initial & Last Name or Official Title & Degree
Katrin Kaarna, MD
Phone
+3727374119
Email
Katrin.Kaarna@kliinikum.ee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Braschinsky, MD, PhD
Organizational Affiliation
Tartu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riina Janno, MSc
Phone
+3725298508
Email
Riina.Janno@kliinikum.ee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Digital-technology Based Interventions on Treatment of Migraine.

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