NCT06935526Enrolling by invitation
Mobile Education and Telephone Monitoring for ICD Patients: Effects on Anxiety, Acceptance, and Self-Efficacy
The Effect of a Mobile Education Program and Telephone Monitoring Developed for Patients With Implantable Cardioverter Defibrillators on Shock Anxiety, Device Acceptance, and Self-Efficacy
Source: ClinicalTrials.gov · Last updated 20 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 26 Sept 2024
- Primary completion date
- 26 Dec 2024
- Lead sponsor
- Akdeniz University
- NCT number
- NCT06935526
What you commit to
- Study type: Interventional
- Planned participants: 88
- From 26 Sept 2024 to the primary completion date, 26 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akdeniz University Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.