MigraineMigreventionNCT05458817
Digital-technology Based Interventions on Treatment of Migraine.
A study testing digital platform in people with Migraine and Primary Headache Disorders, run by Tartu University Hospital at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Migraine, Primary Headache Disorders
- What is being tested?
- digital platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Jan 2022to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- severe somatic disease;
- severe organic mental disorders;
- other chronic pain;
- addictive disorders.
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, 50406
Riina Janno, MSc, +3725298508, Riina.Janno@kliinikum.ee
About this study
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:
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.
- Conditions
- Migraine, Primary Headache Disorders
- Being tested
- digital platform
- Medical subject headings
- Migraine Disorders, Headache Disorders, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. Digital diary | Experimental | 75 participants in the group Receives: Other: digital platform |
| 2. Paper diary | Active comparator | 75 participants in the group Receives: Other: digital platform |
| 3. Digital: diary and headache nurse | Experimental | 75 participants in the group Receives: Other: digital platform |
| 4. Paper diary and conventional headache nurse | Active comparator | 75 participants in the group Receives: Other: digital platform |
| 5. Digital: diary, headache nurse and clinal psychologist | Experimental | 75 participants in the group Receives: Other: digital platform |
| 6. Paper diary, conventional headache nurse and conventional clinical psychologist | Active comparator | 75 participants in the group Receives: Other: digital platform |
| 7. Digital: diary, headache nurse, clinal psychologist and physiotherapist | Experimental | 75 participants in the group Receives: Other: digital platform |
| 8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist | Active comparator | 75 participants in the group Receives: Other: digital platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache frequency
headache diary: number of headache days per month
Measured: 3 months
headache frequency
headache diary: number of headache days per month
Measured: 6 months
headache frequency
headache diary: number of headache days per month
Measured: 9 months
Secondary outcomes (24)
medication use
headache diary: number of headache days per month
Measured: 3 months
medication use
headache diary: number of headache days per month
Measured: 6 months
medication use
headache diary: number of headache days per month
Measured: 9 months
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
Measured: 3 months
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
Measured: 6 months
The effect of headaches on everyday life
Headache Impact Test (HIT-6)
Measured: 9 months
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Measured: 3 months
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Measured: 6 months
Pain acceptance Pain acceptance Pain acceptance
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Measured: 9 months
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Measured: 3 months
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Measured: 6 months
Pain-related anxiety
Pain Anxiety Symptoms Scale (PASS)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 9 months
Patient satisfaction with treatment 1
Headache Attributed Lost Time (HALT)
Measured: 3 months
Patient satisfaction with treatment 2
Headache Under-Response to Treatment (HURT)
Measured: 3 months
Patient satisfaction with treatment 3
Headache Attributed Lost Time (HALT)
Measured: 6 months
Patient satisfaction with treatment 4
Headache Under-Response to Treatment (HURT)
Measured: 6 months
Patient satisfaction with treatment 5
Headache Attributed Lost Time (HALT)
Measured: 9 months
Patient satisfaction with treatment 6
Headache Under-Response to Treatment (HURT)
Measured: 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)
Measured: 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)
Measured: 9 months
Patient's willingness to pay for headache treatment
Willingness to pay bidding game
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Sponsor
- Investigators
- Mark Braschinsky, MD, PhD, Principal investigator, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458817
- Sponsor's protocol ID
- 20148
- Acronym
- Migrevention
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital-technology Based Interventions on Treatment of Migraine.
- ClinicalTrials.gov ID
- NCT05458817
- Acronym / sponsor ID
- Migrevention / 20148
- Conditions
- Migraine, Primary Headache Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1. Digital diary | Experimental | Other: digital platform75 participants in the group |
| 2. Paper diary | Active comparator | Other: digital platform75 participants in the group |
| 3. Digital: diary and headache nurse | Experimental | Other: digital platform75 participants in the group |
| 4. Paper diary and conventional headache nurse | Active comparator | Other: digital platform75 participants in the group |
| 5. Digital: diary, headache nurse and clinal psychologist | Experimental | Other: digital platform75 participants in the group |
| 6. Paper diary, conventional headache nurse and conventional clinical psychologist | Active comparator | Other: digital platform75 participants in the group |
| 7. Digital: diary, headache nurse, clinal psychologist and physiotherapist | Experimental | Other: digital platform75 participants in the group |
| 8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist | Active comparator | Other: digital platform75 participants in the group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital platformPatients 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. | Other | 1. Digital diary, 2. Paper diary, 3. Digital: diary and headache nurse, 4. Paper diary and conventional headache nurse, 5. Digital: diary, headache nurse and clinal psychologist, 6. Paper diary, conventional headache nurse and conventional clinical psychologist, 7. Digital: diary, headache nurse, clinal psychologist and physiotherapist, 8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist |
Primary outcome
headache frequency
Time frame: 3 months
headache diary: number of headache days per month
headache frequency
Time frame: 6 months
headache diary: number of headache days per month
headache frequency
Time frame: 9 months
headache diary: number of headache days per month
24 secondary outcomes
medication use
Time frame: 3 months
medication use
Time frame: 6 months
medication use
Time frame: 9 months
The effect of headaches on everyday life
Time frame: 3 months
The effect of headaches on everyday life
Time frame: 6 months
The effect of headaches on everyday life
Time frame: 9 months
Pain acceptance Pain acceptance Pain acceptance
Time frame: 3 months
Pain acceptance Pain acceptance Pain acceptance
Time frame: 6 months
Pain acceptance Pain acceptance Pain acceptance
Time frame: 9 months
Pain-related anxiety
Time frame: 3 months
Pain-related anxiety
Time frame: 6 months
Pain-related anxiety
Time frame: 9 months
Health related quality of life
Time frame: 3 months
Health related quality of life
Time frame: 6 months
Health related quality of life
Time frame: 9 months
Patient satisfaction with treatment 1
Time frame: 3 months
Patient satisfaction with treatment 2
Time frame: 3 months
Patient satisfaction with treatment 3
Time frame: 6 months
Patient satisfaction with treatment 4
Time frame: 6 months
Patient satisfaction with treatment 5
Time frame: 9 months
Patient satisfaction with treatment 6
Time frame: 9 months
Cost-effectiveness 1
Time frame: 9 months
Cost-effectiveness 2
Time frame: 9 months
Patient's willingness to pay for headache treatment
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Braschinsky, MD, PhD principal investigator
Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital platform in people with Migraine and Primary Headache Disorders, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Braschinsky, MD, PhD (+3727318501, mark.braschinsky@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache frequency (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.