Digital-technology Based Interventions on Treatment of Migraine.

Not Applicable

Recruiting

• Conditions: Primary Headache Disorders; Migraine
• Interventions: Other: digital platform

• Registration Number: NCT05458817
• Lead Sponsor: Tartu University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-07-10
• Study First Posted: 2022-07-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-19
• Primary Completion: 2025-01-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3. Digital: diary and headache nurse	digital platform	75 participants in the group
5. Digital: diary, headache nurse and clinal psychologist	digital platform	75 participants in the group
2. Paper diary	digital platform	75 participants in the group
7. Digital: diary, headache nurse, clinal psychologist and physiotherapist	digital platform	75 participants in the group
8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist	digital platform	75 participants in the group
1. Digital diary	digital platform	75 participants in the group
4. Paper diary and conventional headache nurse	digital platform	75 participants in the group
6. Paper diary, conventional headache nurse and conventional clinical psychologist	digital platform	75 participants in the group

Primary Outcome Measures

Name	Time	Method
headache frequency	9 months	headache diary: number of headache days per month

Secondary Outcome Measures

Name	Time	Method
Patient's willingness to pay for headache treatment	9 months	Willingness to pay bidding game
medication use	9 months	headache diary: number of headache days per month
Patient satisfaction with treatment 1	3 months	Headache Attributed Lost Time (HALT)
Pain-related anxiety	9 months	Pain Anxiety Symptoms Scale (PASS)
Patient satisfaction with treatment 2	3 months	Headache Under-Response to Treatment (HURT)
Patient satisfaction with treatment 3	6 months	Headache Attributed Lost Time (HALT)
Patient satisfaction with treatment 4	6 months	Headache Under-Response to Treatment (HURT)
Patient satisfaction with treatment 5	9 months	Headache Attributed Lost Time (HALT)
Cost-effectiveness 2	9 months	databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - medications reimbursement)
The effect of headaches on everyday life	9 months	Headache Impact Test (HIT-6)
Health related quality of life	9 months	EUROHIS-QOL 8-item index (shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version)
Cost-effectiveness 1	9 months	databases of the Estonian Health Insurance Fund, the Social Insurance Board and the Institute for Health Development (insurance costs per patient - sick leaves compensation)
Pain acceptance Pain acceptance Pain acceptance	9 months	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Patient satisfaction with treatment 6	9 months	Headache Under-Response to Treatment (HURT)

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia