My Healthy Diary - An Electronic Diary for Remote Migraine Monitoring

NCT04828941 | Unknown DMC

• 1 other identifier: 96/CE/JAS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Migraine Disorders; mHealth; Mobile Applications; Health Diaries

Outcome Measures

Primary Outcomes (1)

• Diary compliance

  To assess whether the compliance of migraine patients to the use of an electronic headache diary is superior to adherence to the paper diary. The quantification of adherence will be made in: 1.1.) % Of days per month of headache registration; and 1.2.) % of patients who abandon calendar registration at 13 weeks.

  6 months

Secondary Outcomes (9)

• Patient Preference

  6 months

• Quality of Life (HIT-6)

  6 months

• Quality of Life (MSQ v2.1)

  6 months

• Quality of Life (WHOQOL-BREF)

  6 months

• Incapacity Days

  6 months

Study Arms (2)

Electronic Headache Diary

EXPERIMENTAL

The electronic headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department.

Device: Electronic Headache Diary

Paper Diary

ACTIVE COMPARATOR

The paper headache diary registers: total number of days with headache per month, number of days with migraine per month, number of days with tension headache per month, number of days taking SOS medication per month, number of days with incapacity for work per month, number of days in which patient goes to the emergency department.

Device: Paper Diary

Interventions

Electronic Headache Diary DEVICE

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.

Electronic Headache Diary

Paper Diary DEVICE

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

Paper Diary

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with episodic migraine, diagnosed for more than 6 months.
• Patients with at least 4 headache days per month and a maximum of 15 headache days per month.

You may not qualify if:

• Patients with major psychiatric illness.
• Patients participating in another clinical trial.
• Patients who do not meet diagnostic criteria for episodic migraine according to ICHD-3.
• Illiterate patients or those who are unable to fill the records independently.
• Patients with a previous history of filling in a headache calendar, in the 3 months prior to randomization.
• Patients who do not use a cell phone with Android OS.
• Patients who cannot read or write in Portuguese.

Sponsors & Collaborators

• Unidade Local de Saúde de Matosinhos, EPE: lead

Study Sites (1)

Hospital Pedro Hispano, Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Porto District, 4464-513, Portugal

RECRUITING

Related Publications (11)

• Becker WJ, Findlay T, Moga C, Scott NA, Harstall C, Taenzer P. Guideline for primary care management of headache in adults. Can Fam Physician. 2015 Aug;61(8):670-9.

  PMID: 26273080 BACKGROUND

• Stovner Lj, Hagen K, Jensen R, Katsarava Z, Lipton R, Scher A, Steiner T, Zwart JA. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia. 2007 Mar;27(3):193-210. doi: 10.1111/j.1468-2982.2007.01288.x.

  PMID: 17381554 BACKGROUND

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.

  PMID: 30879893 BACKGROUND

• Nappi G, Jensen R, Nappi RE, Sances G, Torelli P, Olesen J. Diaries and calendars for migraine. A review. Cephalalgia. 2006 Aug;26(8):905-16. doi: 10.1111/j.1468-2982.2006.01155.x.

  PMID: 16886925 BACKGROUND

• Baos V, Ester F, Castellanos A, Nocea G, Caloto MT, Gerth WC; I-Max Study Group. Use of a structured migraine diary improves patient and physician communication about migraine disability and treatment outcomes. Int J Clin Pract. 2005 Mar;59(3):281-6. doi: 10.1111/j.1742-1241.2005.00469.x.

  PMID: 15857323 BACKGROUND

• Allena M, Cuzzoni MG, Tassorelli C, Nappi G, Antonaci F. An electronic diary on a palm device for headache monitoring: a preliminary experience. J Headache Pain. 2012 Oct;13(7):537-41. doi: 10.1007/s10194-012-0473-2. Epub 2012 Jul 28.

  PMID: 22842873 BACKGROUND

• Hundert AS, Huguet A, McGrath PJ, Stinson JN, Wheaton M. Commercially available mobile phone headache diary apps: a systematic review. JMIR Mhealth Uhealth. 2014 Aug 19;2(3):e36. doi: 10.2196/mhealth.3452.

  PMID: 25138438 BACKGROUND

• Kosinski M, Bayliss MS, Bjorner JB, Ware JE Jr, Garber WH, Batenhorst A, Cady R, Dahlof CG, Dowson A, Tepper S. A six-item short-form survey for measuring headache impact: the HIT-6. Qual Life Res. 2003 Dec;12(8):963-74. doi: 10.1023/a:1026119331193.

  PMID: 14651415 BACKGROUND

• Martin BC, Pathak DS, Sharfman MI, Adelman JU, Taylor F, Kwong WJ, Jhingran P. Validity and reliability of the migraine-specific quality of life questionnaire (MSQ Version 2.1). Headache. 2000 Mar;40(3):204-15. doi: 10.1046/j.1526-4610.2000.00030.x.

  PMID: 10759923 BACKGROUND

• Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.

  PMID: 11294956 BACKGROUND

• Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

  PMID: 15085902 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Axel Ferreira, MD

CONTACT

+351926491618; axelferr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhDs

Model Details: Each patient will use the electronic headache diary and the paper diary for a period of 13 weeks, the order of their use will be determined by randomisation.

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 2, 2021
• Study Start: March 28, 2021
• Primary Completion: October 2, 2021
• Study Completion: November 1, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

PT (1)