RecruitingNCT05458817MigreventionUpdated Jan 19, 2023

Digital-technology Based Interventions on Treatment of Migraine.

An interventional study of digital platform in Migraine and Primary Headache Disorders, sponsored by Tartu University Hospital. Recruiting at 1 site in Estonia. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-01-19.

Sponsored by Tartu University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
Started Jan 2022; still recruiting 4 years 10 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 600
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study 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).

Read the detailed description

Aims and purpose:

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.

Conditions studied

Migraine
Primary Headache Disorders

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In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 600 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Tartu University Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

diagnosed migraine, frequent episodic, headache days a month 8-14 days;
patient age 18-64 years;
very good command of the Estonian language both orally and in writing.

Exclusion criteria

Exclusion Criteria:

headaches lasting less than 8 days and more than 14 days per month;
all other primary and/or secondary diagnoses of headache;
under the age of 18 or over 64;
currently severe depression;
psychotic disorders;
pregnancy and lactation;
severe somatic disease;
severe organic mental disorders;
other chronic pain;
addictive disorders.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 600 participants (estimated)

Study arms

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

Interventions

Otherdigital 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 researchers measure

Primary outcomes

headache frequency
headache diary: number of headache days per month
Time frame: 3 months
headache frequency
headache diary: number of headache days per month
Time frame: 6 months
headache frequency
headache diary: number of headache days per month
Time frame: 9 months

Secondary outcomes

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

Study locations

1 of 1 sites recruiting

Tartu University Hospital
Tartu, 50406, Estonia
35 other open studies at this site →
Recruiting
- Riina Janno, MSc · Contact · Riina.Janno@kliinikum.ee · +3725298508
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Jan 2025, 36 months after the start.

Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 36 months is above that.

Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 21, 2022
First posted: Jul 14, 2022
StartActual: Jan 1, 2022
Primary completionEst.: Jan 31, 2025
CompletionEst.: May 31, 2025
Last update: Jan 19, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05458817
Lead sponsor: Tartu University Hospital
Collaborators: University of Tartu
Responsible party: Sponsor
First posted: Jul 14, 2022
Start date: Jan 1, 2022
Primary completion: Jan 31, 2025 (estimated)
Completion: May 31, 2025 (estimated)
Last update: Jan 19, 2023

Study contacts

Mark Braschinsky, MD, PhD

Contact

mark.braschinsky@kliinikum.ee

+3727318501

Katrin Kaarna, MD

Contact

Katrin.Kaarna@kliinikum.ee

+3727374119

Mark Braschinsky, MD, PhD

principal investigator · Tartu University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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