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A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery
Sponsor: Ottawa Heart Institute Research Corporation
Summary
The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery. Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices. Instructions within both arms of this study are considered within reasonable practice in Canada. All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions. All patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24/7 on call nursing program.
Official title: A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
6300
Start Date
2021-08-19
Completion Date
2030-08-01
Last Updated
2025-12-15
Healthy Volunteers
Yes
Conditions
Interventions
Lenient Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Strict Arm Restriction
The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
Locations (1)
University of Ottawa Heart Institute
Ottawa, Ontario, Canada