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A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

Study acronym: LENIENT
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Enrollment target: 2500 to 6300v6 Show 5 more changesShow less
    • Primary completion date: Sep 1, 2025 to Aug 1, 2029
    • Primary endpoint revised
    • Study completion date: Sep 1, 2026 to Aug 1, 2030
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 4 to 3
  3. Primary completion date: Jun 1, 2024 to Sep 1, 2025
    • Study completion date: Jun 1, 2025 to Sep 1, 2026
    v5
  4. 2 versions Re-verified since Dec 8, 2022, no change to tracked fieldsv3-v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2021 to Aug 19, 2021
    • Study description expanded, about 2 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04915261
Lead Sponsor Ottawa Heart Institute Research Corporation
Conditions
(from sponsor)		 Post-Op Complication
Related terms Hematoma, Infections, Postoperative Complications
Enrollment 6,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov