The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study

NCT05556564 | Completed

• 1 other identifier: PROxy202201
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cross-sectional, real-world observational, community pharmacy-based study in which adults treated with a triptan for their migraine will self-report productivity and activity impairment using a web-based portal or paper-based questionnaire.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• The Migraine Disability Assessment (MIDAS) questionnaire

  Patient-reported outcome: The Migraine Disability Assessment (MIDAS) is a 5-item, self-administered questionnaire designed to quantify headache-related disability over the past 3 months. The MIDAS is scored as the sum of five questions, each measured as days in the last 3 months, and then categorized into four disability grades with higher scores indicating greater disability: ''Grade I - Little to no disability'' for 0 to 5 days, ''Grade II - Mild disability'' for 6 to 10 days, ''Grade III - Moderate disability'' for 11 to 20 days and ''Grade IV - Severe disability'' for 21 days and over.

  Baseline

Study Arms (1)

No group

Drug: observational study

Interventions

observational study DRUG

No intervention, observational study

No group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with migraine treated with triptans in Canada

You may qualify if:

• years of age or older;
• New or current prescription (renewal in the last 3 months) of any formulation of triptans medication (i.e., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan and frovatriptan);
• Working full or part-time or going to school full or part-time;
• Ability to read and understand English or French;
• Signature of informed consent form (ICF).

You may not qualify if:

• Patients participating in a clinical trial.
• Patients filling a one-time vacation/emergency prescription (i.e. without a complete pharmacy file).

Sponsors & Collaborators

• PeriPharm: lead

Study Sites (1)

PROxy Network, an initiative of PeriPharm inc.

Montreal, Quebec, H2Y 2H4, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Jean Lachaine

  PeriParm inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 27, 2022
• Study Start: October 31, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)