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| Name | Class |
|---|---|
| University of Tartu | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Digital diary | Experimental | 75 participants in the group |
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| 2. Paper diary | Active Comparator | 75 participants in the group |
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| 3. Digital: diary and headache nurse | Experimental | 75 participants in the group |
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| 4. Paper diary and conventional headache nurse | Active Comparator | 75 participants in the group |
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| 5. Digital: diary, headache nurse and clinal psychologist | Experimental | 75 participants in the group |
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| 6. Paper diary, conventional headache nurse and conventional clinical psychologist | Active Comparator | 75 participants in the group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| digital platform | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| headache frequency | headache diary: number of headache days per month | 3 months |
| headache frequency | headache diary: number of headache days per month | 6 months |
| headache frequency | headache diary: number of headache days per month | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| medication use | headache diary: number of headache days per month | 3 months |
| medication use | headache diary: number of headache days per month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Braschinsky, MD, PhD | Contact | +3727318501 | mark.braschinsky@kliinikum.ee | |
| Katrin Kaarna, MD | Contact | +3727374119 | Katrin.Kaarna@kliinikum.ee |
| Name | Affiliation | Role |
|---|---|---|
| Mark Braschinsky, MD, PhD | Tartu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Recruiting | Tartu | 50406 | Estonia |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 7. Digital: diary, headache nurse, clinal psychologist and physiotherapist | Experimental | 75 participants in the group |
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| 8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist | Active Comparator | 75 participants in the group |
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| 6 months |
| medication use | headache diary: number of headache days per month | 9 months |
| The effect of headaches on everyday life | Headache Impact Test (HIT-6) | 3 months |
| The effect of headaches on everyday life | Headache Impact Test (HIT-6) | 6 months |
| The effect of headaches on everyday life | Headache Impact Test (HIT-6) | 9 months |
| Pain acceptance Pain acceptance Pain acceptance | Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) | 3 months |
| Pain acceptance Pain acceptance Pain acceptance | Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) | 6 months |
| Pain acceptance Pain acceptance Pain acceptance | Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) | 9 months |
| Pain-related anxiety | Pain Anxiety Symptoms Scale (PASS) | 3 months |
| Pain-related anxiety | Pain Anxiety Symptoms Scale (PASS) | 6 months |
| Pain-related anxiety | Pain Anxiety Symptoms Scale (PASS) | 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) | 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) | 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) | 9 months |
| Patient satisfaction with treatment 1 | Headache Attributed Lost Time (HALT) | 3 months |
| Patient satisfaction with treatment 2 | Headache Under-Response to Treatment (HURT) | 3 months |
| Patient satisfaction with treatment 3 | Headache Attributed Lost Time (HALT) | 6 months |
| Patient satisfaction with treatment 4 | Headache Under-Response to Treatment (HURT) | 6 months |
| Patient satisfaction with treatment 5 | Headache Attributed Lost Time (HALT) | 9 months |
| Patient satisfaction with treatment 6 | Headache Under-Response to Treatment (HURT) | 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) | 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) | 9 months |
| Patient's willingness to pay for headache treatment | Willingness to pay bidding game | 9 months |