SAGE-AF Study Fibrillation (SAGE-AF) Study — SAGE-AF  

Atrial Fibrillation Clinical Trial

Official title: Systematic Assessment Of Geriatric Elements In Atrial Fibrillation Study

Status Recruiting

Clinical Trial Summary

The goal of this research is to enhance anti-coagulant (AC) decision-making in older patients with atrial fibrillation using a geriatric assessment and identifying important factors that affect their use and important anticoagulant use outcomes (e.g., bleeding, time in therapeutic range).

Clinical Trial Description

Prospective participants (≥65 years) with AF will be enrolled over a 30-month recruitment period. In person assessments will be performed at baseline, 12, and 24 months. Investigators will also collect data about sources and use of regular medical care, pharmacy services, AC status, repeat hospitalizations, outpatient visits, use of AC clinic services and cardiovascular procedures over the 30-month follow-up period. Investigators will review the medical records for all hospitalizations related to CVD or bleeding over 30-months and validate all major bleeding and cardiovascular disease (CVD) events; investigators will also review records of outpatient encounters for changes in AC status or dosing.

Data that will be collected at baseline via in-person interview which will include a geriatric assessment (frailty, cognitive function, social support, depressive symptoms, fall history, vision, hearing) as well as socioeconomic information, health related behaviors, AF-specific quality of life, medication adherence, use of medications and services, and satisfaction with AC. Follow-up assessments will include all elements of the baseline interview, excluding data constant over time (e.g., race/ethnicity), as well as a scripted interview intended to solicit development of any key primary endpoints (e.g., bleeding) or secondary endpoints (e.g., stroke/TIA, systemic embolism, myocardial infarction).

Baseline Patient Interview: Participants will undergo a 45-60 minute interviewer-administered, computer assisted interview with standardized measures.

Follow-up Interviews: All patients will undergo two in-clinic follow-up assessments at 12, and 24 months. These time points were selected to coincide with typical follow-up and over a time-period in which the components of the geriatric assessment and patient reported outcomes related to AC use would show change (Follow-Up Assessment). In-person follow-up interviews will be conducted in the same manner as the baseline assessments. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT03479281
• Study type: Observational
• Source: University of Massachusetts, Worcester
• Contact: Michelle Maynard
• Phone: 508-856-6915
• Email: SAGE-AF@umassmed.edu
• Status: Recruiting
• Start date: June 27, 2016
• Completion date: January 31, 2020