San Francisco VA Medical Center
San Francisco, California, 94121, United States
NCT Number: NCT07477964
The investigators tested the effect of mailing informational postcards to patients with cardiovascular implantable electronic devices (CIED) who have lost continuous RM connectivity because their home monitor had become disconnected from their CIED.
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Interventional
Not applicable
San Francisco, California, 94121, United States
Objective: To determine the effect on remote monitoring (RM) connectivity of mailing informational postcards to patients with CIEDs who have lost continuous RM connectivity because their home monitor had become disconnected from their CIED. Design: Parallel prospective randomized controlled trial (RCT). Setting: Veterans Health Administration. Participants: Randomized selection of all patients with CIEDs that had become disconnected from their home monitor for ≥16 but ≤40 days from the manufacturer's RM service. Exposure: The investigators developed postcards that notified patients about RM disconnection, described RM's clinical benefits, and provided the customer service number of their CIED manufacturer. Twice monthly, the investigators randomized patients to either receive or not receive the postcard. Main Outcomes and Measures: Primary outcome was median time to reconnection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants received a postcard with a tailored notice that their CIED was disconnected from remote monitoring with tips to reconnect and prompts to follow up with their CIED manufacturer or local VA clinic.
Time frame: From intervention (mailing) to at least 100 days after intervention.
Time to reconnection using median survival time and assessing differences in each group through log-rank test. Assess relative difference across two groups through Cox proportional hazards regression.
Time frame: From intervention (mailing) to at least 100 days after intervention.
Assesses whether a transmission received within 10 days of scheduled transmission assessed using logistic regression.
San Francisco VA Health Care System
Fed
Postcards to Improve Remote Monitoring Connectivity Among Patients With Disconnected Cardiovascular Implantable Electronic Devices: A Randomized, Controlled Trial
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