Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828941
Status:
UNKNOWN
Last Update Posted:
2021-04-02
First Post:
2021-03-27
Brief Title:
My Healthy Diary - An Electronic Diary for Remote Migraine Monitoring
Sponsor:
Unidade Local de Saúde de Matosinhos EPE
Organization:
Unidade Local de Saúde de Matosinhos EPE
Study Overview
Official Title:
A 26-week Randomized Clinical Trial of an Electronic Headache Diary in Migraine Patients
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-Migra
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
Detailed Description:
Headache is one of the main reasons for seeking primary health care and an important cause of absenteeism at work and decreased quality of life in the population being the major neurological cause of disability in young adults and middle-aged adults Although the subjectivity of the complaints and the great intra and inter-individual variability of clinical presentations hinder its epidemiological study it is estimated that the overall prevalence of headache throughout life is 66 46-78 in tension-type headache 14-16 for migraine and 01-03 for cluster headache Migraine in particular is a primary headache with an estimated prevalence of 11 to 14 in adult women and 4 to 9 in adult men In addition it is assumed that up to 20 of absences from work can be attributed to headaches with the inherent socio-economic impacts
Headache is a very frequent complaint in the primary care setting However the differential diagnosis can be complicated at this level Primary headache diagnosis is made almost exclusively through clinical history taking for this purpose clinicians use the criteria in the International Classification of Headache Disorders currently on its 3rd version However its application is often challenging and time-consuming especially in a primary care setting where physicians are very limited on time Nonetheless a correct diagnosis is essential as treatment varies among the primary headaches and also within the same headache type according to its frequency
The episodic nature of headaches increases the risk of memory bias towards more severe or more recent crises To avoid this patients nowadays use a paper calendar This calendar makes it possible to monitor more reliably the response to therapy and to identify the need for any adjustments
However the paper calendar has many limitations such as the possibility of filling in immediately before consultations instead of non-biased daily records In addition the paper or card used can be lost is more easily forgotten and cannot be consulted remotely by the attending physician In the current digital landscape we have seen a transition in registration methods for semi-automated electronic platforms considered more practical and appealing to users However most in-app headache diaries are not validated and are mainly written in English
Having these ideas in mind the investigators decided to develop an app-based electronic headache diary that would not only permit a better adhesion to follow-up but also remote monitoring of headache patients To study the applicability and the usefulness of this idea the investigators designed a randomized clinical trial with a crossover design where episodic migraine patients would be randomized to the use of the app or of a paper headache diary Each patient would use the app and the paper diary for a period of 13 weeks
In the paper and electronic diary patients will record headache days headache type migraine or tension-type headache headache intensity with a scale from 0 to 10 intake of acute headache medication missing work days due to headache and recurrence to the emergency department due to headache
The investigators will also measure headache burden with the portuguese versions of HIT-6 MSQ v21 and MiDAS scales and quality of life with the WHOQOL-BREF at the beginning at the crossover point and at the end of the study Also the study will evaluate prophylactic medication compliance at the beginning at the crossover point and at the end of the study through a questionnaire User preference will be measured through a questionnaire using a Likert type scale at the end of the study
Headache is a very frequent complaint in the primary care setting However the differential diagnosis can be complicated at this level Primary headache diagnosis is made almost exclusively through clinical history taking for this purpose clinicians use the criteria in the International Classification of Headache Disorders currently on its 3rd version However its application is often challenging and time-consuming especially in a primary care setting where physicians are very limited on time Nonetheless a correct diagnosis is essential as treatment varies among the primary headaches and also within the same headache type according to its frequency
The episodic nature of headaches increases the risk of memory bias towards more severe or more recent crises To avoid this patients nowadays use a paper calendar This calendar makes it possible to monitor more reliably the response to therapy and to identify the need for any adjustments
However the paper calendar has many limitations such as the possibility of filling in immediately before consultations instead of non-biased daily records In addition the paper or card used can be lost is more easily forgotten and cannot be consulted remotely by the attending physician In the current digital landscape we have seen a transition in registration methods for semi-automated electronic platforms considered more practical and appealing to users However most in-app headache diaries are not validated and are mainly written in English
Having these ideas in mind the investigators decided to develop an app-based electronic headache diary that would not only permit a better adhesion to follow-up but also remote monitoring of headache patients To study the applicability and the usefulness of this idea the investigators designed a randomized clinical trial with a crossover design where episodic migraine patients would be randomized to the use of the app or of a paper headache diary Each patient would use the app and the paper diary for a period of 13 weeks
In the paper and electronic diary patients will record headache days headache type migraine or tension-type headache headache intensity with a scale from 0 to 10 intake of acute headache medication missing work days due to headache and recurrence to the emergency department due to headache
The investigators will also measure headache burden with the portuguese versions of HIT-6 MSQ v21 and MiDAS scales and quality of life with the WHOQOL-BREF at the beginning at the crossover point and at the end of the study Also the study will evaluate prophylactic medication compliance at the beginning at the crossover point and at the end of the study through a questionnaire User preference will be measured through a questionnaire using a Likert type scale at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None