SAGE-AF Study Fibrillation (SAGE-AF) Study

Atrial Fibrillation Clinical Trial

— SAGE-AF  

Official title:

Systematic Assessment Of Geriatric Elements In Atrial Fibrillation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479281
• Other study ID #: H00009079
• Status: Recruiting
• First received: October 3, 2017
• Last updated: March 20, 2018
• Start date: June 27, 2016
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2018
• Source: University of Massachusetts, Worcester
• Contact: Michelle Maynard
• Phone: 508-856-6915
• Email: SAGE-AF[@]umassmed.edu
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age 65 and older,

2. Diagnosis of AF (12-lead electrocardiogram showing AF or previous note [within 12 months] documenting AF will be needed to confirm eligibility)

3. CHA2DS2VASc score =2.

4. Capacity to provide informed consent as assessed by a Capacity instrument that combines direct questions about their understanding of study participation with interviewer observations of the patient. If the patient fails the Capacity assessment, they will be excluded.

Exclusion Criteria:

1. Absolute or relative contraindication to AC, including:

2. Active major bleeding.

3. Large esophageal varices.

4. Recent major surgery (<72 hours).

5. Recent (<3 months) major bleeding.

6. Arteriovenous malformation or aneurysm.

7. Planned invasive procedure with high risk for uncontrollable bleeding (e.g., open surgical procedure).

8. Decompensated liver disease.

9. Significant thrombocytopenia (platelet count <50k).

10. Documented hypersensitivity/allergic reaction to oral AC.

11. Indication for AC other than AF, e.g. ventricular thrombus or mechanical mitral valve.

12. Do not speak English.

13. Plan to move from their current residence in the next 2 years.

14. Do not provide informed consent for all study measures.

15. Are Women who are pregnant.

16. Prisoners

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Baseline AF-specific QoL instruments (Atrial Fibrillation Effect on Quality of Life) at 1 Year Follow up and 3 Year Follow 2	This is a validated instrument and has been used to study a variety of cardiac conditions.	Baseline, 1 Year Follow-up, 2 Year Follow-up
Primary	Change from Baseline SAGE-AF Geriatric Frailty Assessment at 1 Year Follow up and 2 Year Follow up	•Frailty (Cardiovascular Health Survey frailty scale based on 5 components)	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline SAGE-AF Geriatric Cognitive Function Assessment at 1 Year Follow up and 2 Year Follow up	•Cognitive function (The Montreal Cognitive Assessment Battery)	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline SAGE-AF Geriatric Social Support Assessment at 1 Year Follow up and 2 Year Follow up	•Social Support (Social Support Scale from the Medical Outcomes Study)	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline SAGE-AF Geriatric Depressive Symptoms Assessment at 1 Year Follow up and 2 Year Follow up	•Depressive Symptoms (Patient Health Questionnaire [PHQ-9])	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline SAGE-AF Geriatric Fall History Assessment at 1 Year Follow up and 2 Year Follow up	•Fall History Patients will self-report number of falls in the last 6-months	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline SAGE-AF Geriatric Vision & Hearling Assessment at 1 Year Follow up and 2 Year Follow up	•Vision & Hearing: Patients will self-report vision and hearing status based on standardized questionnaires	Baseline, 1 Year Follow-up, 2 Year Follow-up
Secondary	Change from Baseline The Anti-Clot Treatment Scale (ACTS) at 1Yrear follow up and 2Year followup	This is a validated 15-item patient-reported instrument of satisfaction with AC that includes AC Burdens and AC Benefits.	Baseline, 1 Year Follow-up, 2 Year Follow-up