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My Healthy Diary - An Electronic Diary for Remote Migraine Monitoring

NCT04828941 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-02

No results posted yet for this study

Summary

This study aims to evaluate the usefulness of an app-based headache diary in episodic migraine patients. For this the investigators will conduct a randomized clinical trial with a crossover design, using the app-based diary and a traditional paper-based headache diary. The patients will use each diary for 13 weeks. The investigators will evaluate diary adhesion after each 13-week period, and also evaluate headache burden and prophylactic medication compliance at the beginning, at the crossover point, and at the end of the study, and acute headache medication use through diary records. The investigators will also evaluate user preference through a questionnaire at the end of the study.

Conditions

  • Episodic Migraine
  • Migraine Disorders

Interventions

DEVICE

Electronic Headache Diary

The electronic headache diary is an app-based diary that permits the registration of headaches, their acute treatment and their associated work incapacity. It also permits real-time monitoring of these data.

DEVICE

Paper Diary

The paper diary permits the registration of the same variables as the electronic diary in paper format.

Sponsors & Collaborators

  • Unidade Local de Saúde de Matosinhos, EPE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-28
Primary Completion
2021-10-02
Completion
2021-11-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828941 on ClinicalTrials.gov