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

Tartu University Hospital

Status: Enrolling

Conditions: Migraine; Primary Headache Disorders

Treatments: Other: digital platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05458817

20148 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 8 patient groups

1. Digital diary

Experimental group

Description:

75 participants in the group

Treatment:

Other: digital platform

2. Paper diary

Active Comparator group

Description:

75 participants in the group

Treatment:

Other: digital platform

3. Digital: diary and headache nurse

Experimental group

Description:

75 participants in the group

Treatment:

Other: digital platform

4. Paper diary and conventional headache nurse

Active Comparator group

Description:

75 participants in the group

Treatment:

Other: digital platform

5. Digital: diary, headache nurse and clinal psychologist

Experimental group

Description:

75 participants in the group

Treatment:

Other: digital platform

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

Active Comparator group

Description:

75 participants in the group

Treatment:

Other: digital platform

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

Experimental group

Description:

75 participants in the group

Treatment:

Other: digital platform

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

Active Comparator group

Description:

75 participants in the group

Treatment:

Other: digital platform