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Clinical Trials/NCT05458817
NCT05458817
Recruiting
N/A

Digital-technology Based Interventions on Treatment of Migraine.

Tartu University Hospital1 site in 1 country600 target enrollmentJanuary 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Migraine
Sponsor
Tartu University Hospital
Enrollment
600
Locations
1
Primary Endpoint
headache frequency
Status
Recruiting
Last Updated
3 years ago

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. 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
May 31, 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

headache frequency

Time Frame: 9 months

headache diary: number of headache days per month

Secondary Outcomes

  • 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)
  • Cost-effectiveness 2(9 months)
  • The effect of headaches on everyday life(9 months)
  • Health related quality of life(9 months)
  • Cost-effectiveness 1(9 months)
  • Pain acceptance Pain acceptance Pain acceptance(9 months)
  • Patient satisfaction with treatment 6(9 months)

Study Sites (1)

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