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Search / Trial NCT06935526

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

Launched by AKDENIZ UNIVERSITY · Apr 11, 2025

Trial Information

Current as of September 11, 2025

Enrolling by invitation

Keywords

Device Acceptance Shock Anxiety Implantable Cardioverter Defibrillator Self Efficacy Nursing

ClinConnect Summary

This study is testing whether a mobile education program for people with an implanted cardioverter defibrillator (ICD) helps reduce anxiety about shocks, improves how people feel about their device, and increases confidence in managing their health. It’s a randomized, single-blind trial (patients don’t know which group they’re in) with two groups: one gets the full mobile education program plus phone check-ins, and the other gets a shorter, standard two-page summary. About 88 adults with ICDs are planned to join at Akdeniz University in Turkey, with data collected at the start and again after 12 weeks.

To be eligible, adults 18 or older must have an ICD, be able to read and write, own an Android smartphone with internet, and not have certain cognitive or psychiatric issues. Those who don’t complete the second phone follow-up or don’t use the mobile app regularly may be excluded. Researchers will measure shock anxiety (FSAS), device acceptance (FPAS), and self-efficacy/outcome expectations (OE-ICD and SB-ICD) before and after the 3-month program. Results aren’t available yet—the study is currently enrolling with completion expected in 2025.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Having an ICD implant
  • Being able to read and write
  • Being 18 years of age or older
  • Not having a cognitive or communication disability
  • Not having a diagnosed psychiatric disease
  • Not having a generalized anxiety disorder (GAD-7 test score \<8)\*
  • Not having a vision problem to the extent that it prevents the use of technological devices
  • Having the knowledge and skills to use technological devices
  • Having a smartphone that runs on the Android operating system and has internet access
  • Agreeing to participate in the study
  • Exclusion Criteria:
  • Patient not continuing after the second telephone follow-up phase of the study
  • Not using the mobile application regularly (frequency of use monitored by the application)

About Akdeniz University

Akdeniz University is a leading academic institution located in Antalya, Turkey, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Akdeniz University leverages its extensive expertise and state-of-the-art facilities to facilitate innovative research initiatives aimed at improving patient outcomes. The university collaborates with a diverse range of stakeholders, including healthcare professionals, researchers, and industry partners, to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. Through its dedication to excellence in research, Akdeniz University plays a pivotal role in contributing to the development of new therapies and enhancing the understanding of various medical conditions.

Locations

Antalya, Turkey

Antalya, Konyaaltı, Turkey

Patients applied

0 patients applied

Trial Officials

Mediha SERT GÖKÇEBEL, Researcher

Study Director

Akdeniz University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported