NCT05458817

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

January 21, 2022

Last Update Submit

January 16, 2023

Conditions

MigrainePrimary Headache Disorders

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (24)

  • medication use

    3 months

  • medication use

    6 months

  • medication use

    9 months

  • The effect of headaches on everyday life

    3 months

  • The effect of headaches on everyday life

    6 months

  • +19 more secondary outcomes

Study Arms (8)

1. Digital diary

EXPERIMENTAL

75 participants in the group

Other: digital platform

2. Paper diary

ACTIVE COMPARATOR

75 participants in the group

Other: digital platform

3. Digital: diary and headache nurse

EXPERIMENTAL

75 participants in the group

Other: digital platform

4. Paper diary and conventional headache nurse

ACTIVE COMPARATOR

75 participants in the group

Other: digital platform

5. Digital: diary, headache nurse and clinal psychologist

EXPERIMENTAL

75 participants in the group

Other: digital platform

6. Paper diary, conventional headache nurse and conventional clinical psychologist

ACTIVE COMPARATOR

75 participants in the group

Other: digital platform

7. Digital: diary, headache nurse, clinal psychologist and physiotherapist

EXPERIMENTAL

75 participants in the group

Other: digital platform

8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist

ACTIVE COMPARATOR

75 participants in the group

Other: digital platform

Interventions

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.

1. Digital diary2. Paper diary3. Digital: diary and headache nurse4. Paper diary and conventional headache nurse5. Digital: diary, headache nurse and clinal psychologist6. Paper diary, conventional headache nurse and conventional clinical psychologist7. Digital: diary, headache nurse, clinal psychologist and physiotherapist8. Paper diary, conventional: headache nurse, clinal psychologist and physiotherapist

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

MeSH Terms

Conditions

Migraine DisordersHeadache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mark Braschinsky, MD, PhD

    Tartu University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Braschinsky, MD, PhD

CONTACT

+3727318501mark.braschinsky@kliinikum.ee

Katrin Kaarna, MD

CONTACT

+3727374119Katrin.Kaarna@kliinikum.ee

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2022

First Posted

July 14, 2022

Study Start

January 1, 2022

Primary Completion

January 31, 2025

Study Completion

May 31, 2025

Last Updated

January 19, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)