Digital-technology Based Interventions on Treatment of Migraine.
NCT ID: NCT05458817
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2022-01-01
2025-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1. Digital diary
75 participants in the group
digital 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.
2. Paper diary
75 participants in the group
digital 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.
3. Digital: diary and headache nurse
75 participants in the group
digital 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.
4. Paper diary and conventional headache nurse
75 participants in the group
digital 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.
5. Digital: diary, headache nurse and clinal psychologist
75 participants in the group
digital 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.
6. Paper diary, conventional headache nurse and conventional clinical psychologist
75 participants in the group
digital 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.
7. Digital: diary, headache nurse, clinal psychologist and physiotherapist
75 participants in the group
digital 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.
8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist
75 participants in the group
digital 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.
Interventions
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digital 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.
Eligibility Criteria
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Inclusion Criteria
2. patient age 18-64 years;
3. very good command of the Estonian language both orally and in writing.
Exclusion Criteria
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.
18 Years
64 Years
ALL
No
Sponsors
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University of Tartu
OTHER
Tartu University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mark Braschinsky, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tartu University Hospital
Locations
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Tartu University Hospital
Tartu, , Estonia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20148
Identifier Type: -
Identifier Source: org_study_id
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