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NOT YET RECRUITING
NCT05973240

Developing Anticoagulation Self-Report Measure in Adults

Sponsor: IRCCS Policlinico S. Donato

View on ClinicalTrials.gov

Summary

The use of oral anticoagulants has been increasing globally to prevent strokes associated with atrial fibrillation and heart valve replacements. Patients on long-term anticoagulation have the option to self-test their blood clotting time using point-of-care testing equipment (POCT). They can choose to self-manage their medication dosage or self-monitor and seek dose adjustments from a clinic. Studies have shown that self-testing approaches are effective and cost-effective. However, future research should focus on understanding the factors that influence people's preparedness for self-testing, such as health literacy, self-efficacy, and perceived support. Assessing preparedness is crucial for tailoring healthcare delivery and supporting patient education. Highlighting preparedness can also encourage the adoption of self-testing approaches in countries facing barriers to implementation.

Official title: Multiphase Research to Develop a Self-report Measure of the Preparedness for Self-Monitoring and Self-Management of Oral Anticoagulation in Adults (The PERSONAE Project)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

305

Start Date

2025-06

Completion Date

2026-10

Last Updated

2025-04-30

Healthy Volunteers

No

Interventions

OTHER

Participation in an web-based survey

Patients who agree to participate will access a web-based survey (SurveyMonkey) via social media, mobile messages, or emails. The invitation will provide study details, eligibility criteria, and tasks. Patients will confirm inclusion/exclusion criteria upon access, and those ineligible will opt out. Data collection will take approximately 10 minutes per patient. Collected data will be sent to an electronic data collector and saved as an eCRF file in REDCap. The study will conduct two cross-sectional data collection rounds using web surveys to ensure anonymity. Convenience sampling will target anticoagulated patient associations' webpages and social media (e.g., Feder-AIPA, AICCA). In the second round, participants will be informed not to resubmit if they have already completed the survey to avoid overlapping responses.

Locations (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy