Developing Anticoagulation Self-Report Measure in Adults

NCT05973240 | Withdrawn

• 1 other identifier: 52/INT/2023
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adults Undergoing Oral Anticoagulation Therapy

Keywords

Anticoagulation; Multiphase; Self-monitoring; Self-management

Outcome Measures

Primary Outcomes (1)

• Development and validation of the first self-report measure assessing the preparedness for self-monitoring and self-management of oral anticoagulation in adults (the PERSONAE scale)

  The PERSONAE scale will be developed and validated initially among Italian adult patients; however, it will be designed to potentially meet the needs for a scaling-up in diverse age groups and internationally.

  October 2023 - August 2024

Secondary Outcomes (1)

• Description of preliminary levels of preparedness for self-monitoring and self-management of oral anticoagulation in Italian adults.

  September 2024 - February 2025

Study Arms (2)

Sample derived from the first data collection round (MSA)

Patients have to be aged 18 years and older, cross in an anticoagulation clinic for at least three months, have appropriate cognitive functioning as determined by the six-item screener, and have the ability to give informed consent will be the inclusion criteria. Patients will be excluded if their Charlson Comorbidity Index (CCI) is high (CCI \> 4) to account for any comorbidity-related variability and assure the homogeneity of the study sample.

Other: Participation in an web-based survey

Sample derived from the second data collection round (CFA)

Patients have to be aged 18 years and older, cross in an anticoagulation clinic for at least three months, have appropriate cognitive functioning as determined by the six-item screener, and have the ability to give informed consent will be the inclusion criteria. Patients will be excluded if their Charlson Comorbidity Index (CCI) is high (CCI \> 4) to account for any comorbidity-related variability and assure the homogeneity of the study sample.

Other: Participation in an web-based survey

Interventions

Participation in an web-based survey OTHER

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.

Sample derived from the first data collection round (MSA); Sample derived from the second data collection round (CFA)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients have to be aged 18 years and older, cross in an anticoagulation clinic for at least three months, have appropriate cognitive functioning as determined by the six-item screener, and have the ability to give informed consent will be the inclusion criteria. Patients will be excluded if their Charlson Comorbidity Index (CCI) is high (CCI \> 4) to account for any comorbidity-related variability and assure the homogeneity of the study sample.

You may qualify if:

• Adults (aged over 18 year old)
• In an anticoagulation clinic for at least three months
• Ability to give informed consent
• CCI ≤ 4
• Age \< 18 years
• Not in an anticoagulation clinic for at least three months
• Inability to give informed consent
• CCI \> 4

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

Related Publications (26)

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  PMID: 40009845 DERIVED

Study Officials

• Rosario Caruso

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 2, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

IT (1)