Clinical trial NCT05458817: Digital-technology Based Interventions on Treatment of Migraine.
Official title: Digital-technology Based Interventions on Treatment of Migraine.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Primary Headache Disorders
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Tartu
First posted: 2022-07-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: headache frequency
timeFrame: 3 months
measure: headache frequency
timeFrame: 6 months
measure: headache frequency
timeFrame: 9 months
Secondary outcomes:
measure: medication use
timeFrame: 3 months
measure: medication use
timeFrame: 6 months
measure: medication use
timeFrame: 9 months
measure: The effect of headaches on everyday life
timeFrame: 3 months
measure: The effect of headaches on everyday life
timeFrame: 6 months
measure: The effect of headaches on everyday life
timeFrame: 9 months
measure: Pain acceptance Pain acceptance Pain acceptance
timeFrame: 3 months
measure: Pain acceptance Pain acceptance Pain acceptance
timeFrame: 6 months
measure: Pain acceptance Pain acceptance Pain acceptance
timeFrame: 9 months
measure: Pain-related anxiety
timeFrame: 3 months
measure: Pain-related anxiety
timeFrame: 6 months
measure: Pain-related anxiety
timeFrame: 9 months
measure: Health related quality of life
timeFrame: 3 months
measure: Health related quality of life
timeFrame: 6 months
measure: Health related quality of life
timeFrame: 9 months
measure: Patient satisfaction with treatment 1
timeFrame: 3 months
measure: Patient satisfaction with treatment 2
timeFrame: 3 months
measure: Patient satisfaction with treatment 3
timeFrame: 6 months
measure: Patient satisfaction with treatment 4
timeFrame: 6 months
measure: Patient satisfaction with treatment 5
timeFrame: 9 months
measure: Patient satisfaction with treatment 6
timeFrame: 9 months
measure: Cost-effectiveness 1
timeFrame: 9 months
measure: Cost-effectiveness 2
timeFrame: 9 months
measure: Patient's willingness to pay for headache treatment
timeFrame: 9 months
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: Tartu University Hospital
name: Mark Braschinsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: