Digital-technology Based Interventions on Treatment of Migraine.

Migraine Clinical Trial

— Migrevention  

Official title:

Digital-technology Based Interventions on Treatment of Migraine.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05458817
• Other study ID #: 20148
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2023
• Source: Tartu University Hospital
• Contact: Mark Braschinsky, MD, PhD
• Phone: +3727318501
• Email: mark.braschinsky[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Migraine
• Migraine Disorders
• Primary Headache Disorders

Intervention

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.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	headache frequency	headache diary: number of headache days per month	3 months
Primary	headache frequency	headache diary: number of headache days per month	6 months
Primary	headache frequency	headache diary: number of headache days per month	9 months
Secondary	medication use	headache diary: number of headache days per month	3 months
Secondary	medication use	headache diary: number of headache days per month	6 months
Secondary	medication use	headache diary: number of headache days per month	9 months
Secondary	The effect of headaches on everyday life	Headache Impact Test (HIT-6)	3 months
Secondary	The effect of headaches on everyday life	Headache Impact Test (HIT-6)	6 months
Secondary	The effect of headaches on everyday life	Headache Impact Test (HIT-6)	9 months
Secondary	Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	3 months
Secondary	Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	6 months
Secondary	Pain acceptance Pain acceptance Pain acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	9 months
Secondary	Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	3 months
Secondary	Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	6 months
Secondary	Pain-related anxiety	Pain Anxiety Symptoms Scale (PASS)	9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction with treatment 1	Headache Attributed Lost Time (HALT)	3 months
Secondary	Patient satisfaction with treatment 2	Headache Under-Response to Treatment (HURT)	3 months
Secondary	Patient satisfaction with treatment 3	Headache Attributed Lost Time (HALT)	6 months
Secondary	Patient satisfaction with treatment 4	Headache Under-Response to Treatment (HURT)	6 months
Secondary	Patient satisfaction with treatment 5	Headache Attributed Lost Time (HALT)	9 months
Secondary	Patient satisfaction with treatment 6	Headache Under-Response to Treatment (HURT)	9 months
Secondary	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
Secondary	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
Secondary	Patient's willingness to pay for headache treatment	Willingness to pay bidding game	9 months