Digital-technology Based Interventions on Treatment of Migraine.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tartu University Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- headache frequency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
1. Digital diary
75 participants in the group
Intervention: digital platform (Other)
2. Paper diary
75 participants in the group
Intervention: digital platform (Other)
3. Digital: diary and headache nurse
75 participants in the group
Intervention: digital platform (Other)
4. Paper diary and conventional headache nurse
75 participants in the group
Intervention: digital platform (Other)
5. Digital: diary, headache nurse and clinal psychologist
75 participants in the group
Intervention: digital platform (Other)
6. Paper diary, conventional headache nurse and conventional clinical psychologist
75 participants in the group
Intervention: digital platform (Other)
7. Digital: diary, headache nurse, clinal psychologist and physiotherapist
75 participants in the group
Intervention: digital platform (Other)
8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist
75 participants in the group
Intervention: digital platform (Other)
Outcomes
Primary Outcomes
headache frequency
Time Frame: 9 months
headache diary: number of headache days per month
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
Secondary Outcomes
- Cost-effectiveness 2(9 months)
- Pain acceptance Pain acceptance Pain acceptance(9 months)
- Patient's willingness to pay for headache treatment(9 months)
- medication use(9 months)
- Patient satisfaction with treatment 1(3 months)
- Pain-related anxiety(9 months)
- Patient satisfaction with treatment 2(3 months)
- Patient satisfaction with treatment 3(6 months)
- Patient satisfaction with treatment 4(6 months)
- Patient satisfaction with treatment 5(9 months)
- The effect of headaches on everyday life(9 months)
- Health related quality of life(9 months)
- Cost-effectiveness 1(9 months)
- Patient satisfaction with treatment 6(9 months)
- medication use(3 months)
- medication use(6 months)
- The effect of headaches on everyday life(3 months)
- The effect of headaches on everyday life(6 months)
- Pain acceptance Pain acceptance Pain acceptance(3 months)
- Pain acceptance Pain acceptance Pain acceptance(6 months)
- Pain-related anxiety(3 months)
- Pain-related anxiety(6 months)
- Health related quality of life(3 months)
- Health related quality of life(6 months)