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

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).

Study Overview

• Status: Recruiting
• Conditions: Migraine; Primary Headache Disorders
• Intervention / Treatment: Other: digital platform

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Braschinsky, MD, PhD; Phone Number: +3727318501; Email: mark.braschinsky@kliinikum.ee
• Study Contact Backup: Name: Katrin Kaarna, MD; Phone Number: +3727374119; Email: Katrin.Kaarna@kliinikum.ee

Study Locations

• Estonia
  • Tartu, Estonia, 50406
    • Recruiting
    • Tartu University Hospital
    • Contact: Riina Janno, MSc; Phone Number: +3725298508; Email: Riina.Janno@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1. Digital diary; 75 participants in the group	Other: digital platform; 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.
Active Comparator: 2. Paper diary; 75 participants in the group	Other: digital platform; 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.
Experimental: 3. Digital: diary and headache nurse; 75 participants in the group	Other: digital platform; 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.
Active Comparator: 4. Paper diary and conventional headache nurse; 75 participants in the group	Other: digital platform; 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.
Experimental: 5. Digital: diary, headache nurse and clinal psychologist; 75 participants in the group	Other: digital platform; 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.
Active Comparator: 6. Paper diary, conventional headache nurse and conventional clinical psychologist; 75 participants in the group	Other: digital platform; 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.
Experimental: 7. Digital: diary, headache nurse, clinal psychologist and physiotherapist; 75 participants in the group	Other: digital platform; 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.
Active Comparator: 8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist; 75 participants in the group	Other: digital platform; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
headache frequency	headache diary: number of headache days per month	3 months
headache frequency	headache diary: number of headache days per month	6 months
headache frequency	headache diary: number of headache days per month	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
medication use	headache diary: number of headache days per month	3 months
medication use	headache diary: number of headache days per month	6 months
medication use	headache diary: number of headache days per month	9 months
The effect of headaches on everyday life	Headache Impact Test (HIT-6)	3 months
The effect of headaches on everyday life	Headache Impact Test (HIT-6)	6 months
The effect of headaches on everyday life	Headache Impact Test (HIT-6)	9 months
Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	3 months
Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	6 months
Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	9 months
Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	3 months
Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	6 months
Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	9 months
Health related quality of life	EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)	3 months
Health related quality of life	EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)	6 months
Health related quality of life	EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)	9 months
Patient satisfaction with treatment 1	Headache Attributed Lost Time (HALT)	3 months
Patient satisfaction with treatment 2	Headache Under-Response to Treatment (HURT)	3 months
Patient satisfaction with treatment 3	Headache Attributed Lost Time (HALT)	6 months
Patient satisfaction with treatment 4	Headache Under-Response to Treatment (HURT)	6 months
Patient satisfaction with treatment 5	Headache Attributed Lost Time (HALT)	9 months
Patient satisfaction with treatment 6	Headache Under-Response to Treatment (HURT)	9 months
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)	9 months
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)	9 months
Patient's willingness to pay for headache treatment	Willingness to pay bidding game	9 months

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Collaborators: University of Tartu
• Investigators: Principal Investigator: Mark Braschinsky, MD, PhD, Tartu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 31, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Migraine Disorders; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: 20148 (Other Identifier: City of Hope Medical Center)

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