Clinical Trial

Mobile Education and Telephone Monitoring for ICD Patients: Effects on Anxiety, Acceptance, and Self-Efficacy

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Aim: This study was conducted to determine the effect of a mobile education program and telephone monitoring developed for patients with implantable cardioverter defibrillators (ICD) on shock anxiety, device acceptance, and self-efficacy. Method: The study was designed as a single-blind, randomized controlled trial consisting of two phases. In the first phase, the Mobile ICD Education Program (M-ICDEP) was developed. In the second phase, the effectiveness of M-ICDEP was evaluated through a randomized controlled design with 88 ICD patients who attended routine battery check-ups. Research data were collected through the mobile education program using the Personal Information Form, Florida Shock Anxiety Scale (FSAS), Florida Patient Acceptance Scale (FPAS), and the Self-Efficacy and Outcome Expectations Scales After ICD Implantation (OE-ICD and SB-ICD). Additionally, patients underwent a shock management simulation via M-ICDEP, and their data were assessed using the Shock Management Control Form, which was included in the evaluation of shock anxiety. Patients in both the intervention and control groups used M-ICDEP for three months. The control group had access only to the brief educational booklet section containing general information, while the intervention group had access to all sections. Patients in the intervention group also received telephone follow-ups during the second, fifth, and eighth weeks of the monitoring period. Data were collected twice: once before the intervention (pre-test) and once in the third month (post-test). Statistical analyses will conducted using the SAS 9.4 software package.
Trial Details
NCT Number NCT06935526
Lead Sponsor Akdeniz University
Collaborators: Koç University
Conditions Patient Acceptance of Health Care, Nursing, Implantable Cardioverter Defibrillator (ICD), Self-Efficacy, Shock, Cardiogenic
Enrollment 88 participants
Start Date 2024-09-26
Primary Completion 2024-12-26 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-20