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

April 11, 2025 updated by: Mediha SERT, Akdeniz University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

  1. Definition and Importance of the Problem

    Implantable cardioverter defibrillators (ICDs) are devices developed to prevent sudden cardiac death resulting from ventricular arrhythmias. According to the 2017 guidelines of the European Heart Rhythm Association, the annual number of ICD implantations per million people is reported to be 107 worldwide and 115 in Turkey. Furthermore, over the past decade, implantation rates have increased by 44% globally and 804.1% in Turkey. Although ICD therapy has been proven to reduce mortality by 28-40% and is more effective than antiarrhythmic drugs, living with an ICD can lead to various psychosocial problems in patients. In particular, anxiety and device adaptation problems are frequently encountered after implantation.

    The foreign nature of the ICD, concerns about living dependently on the device, its activation during potentially fatal arrhythmias, and its capability to deliver shocks contribute to increased anxiety. Studies indicate that 44-55% of patients experience shock-related anxiety, with uncertainty regarding the sensation, location, and timing of shocks exacerbating this distress. Additionally, 95% of individuals who have experienced a shock develop anxiety. Anxiety and shock experiences can hinder device acceptance, adversely affecting patients' daily lives. It has been reported that individuals struggling with device acceptance exhibit lower levels of self-efficacy and that self-efficacy plays a crucial psychological role in disease adaptation. Consequently, assessing patients' self-efficacy is of significant importance.

    Adequate patient education, telephone follow-ups, and continuous care have been shown to enhance device acceptance and self-efficacy. Despite the recognized importance of patient education and follow-up, 97% of ICD patients report needing further education and monitoring, suggesting a gap in the provision of necessary training.

    Currently, innovative and interactive educational methods, such as mobile health applications and simulation techniques, are widely used for patient education. Mobile applications facilitate easy access to information, while simulation methods provide a realistic learning environment by allowing patients to experience real-life scenarios. While international literature includes studies on the use of mobile health applications for ICD patient monitoring, no studies have been identified that apply a mobile education program. Therefore, this study is expected to contribute innovatively to the literature by providing a realistic learning environment through a mobile education program incorporating different algorithms and a shock management simulation. Additionally, it is hypothesized that mobile education programs and telephone monitoring may improve patients' shock anxiety, device acceptance, and self-efficacy levels.

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  2. Aim of the Study

This study aims to determine the effect of a mobile education program and telephone monitoring developed for ICD patients on shock anxiety, device acceptance, and self-efficacy. It has been designed as a single-blind, randomized controlled trial consisting of two phases. The first phase involves the development of the mobile education program, while the second phase aims to evaluate the impact of the program on patients' shock anxiety, device acceptance, and self-efficacy.

  • Research Hypotheses

The research hypotheses are formulated as follows:

Compared to the control group, ICD patients in the intervention group who receive the mobile education program and telephone monitoring will experience:

  1. H1: A decrease in shock anxiety levels.
  2. H1: An increase in device acceptance levels.
  3. H1: An increase in self-efficacy and outcome expectations levels.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07070
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The group of mobile education programe

The intervention group consists of 44 patients attending routine ICD follow-ups. Patients completed a pre-test before the intervention and a post-test at 12 weeks via M-ICDEP. Data were collected using FSAS, FPAS, OE-ICD, and SB-ICD scales on M-ICDEP. A shock management simulation was conducted at both pre-and post-tests, evaluated with the Shock Management Control Form, and added to shock anxiety data.

The intervention group used M-ICDEP anytime during the 3-month follow-up, which includes three sections: education, summary information, and shock management simulation. The program aimed to reduce shock-related anxiety, increase device acceptance, and enhance self-efficacy. Telephone follow-ups were conducted in the 2nd, 5th, and 8th weeks, evaluating patients using the Telephone Calls Monitoring Form. The information shared during these calls was continued within the training program's scope, ensuring consistent reinforcement of the content.
Other: The mobile training program and telephone follow-ups
The study had three phases: pre-test, implementation, and post-test. Data were collected twice, before the intervention and in the third month, using validated scales and a shock management simulation via the mobile training program (M-ICDEP). M-ICDEP included three sections: an educational section, a two-page summary, and a shock management simulation. All sections were shared with the intervention group. After the pre-test, intervention group patients could log in to M-ICDEP anytime using their email and password, accessing content repeatedly during the three-month follow-up. The researcher conducted telephone follow-ups in the second, fifth, and eighth weeks, evaluating patients using the Telephone Calls Monitoring Form. The information given to the patients during the telephone conversation was continued within the limited of the training program prepared within the scope of M-ICDEP.
Active Comparator: Standard Treatment Group
The control group consists of 44 patients attending routine ICD follow-ups. Patients completed a pre-test before the intervention and a post-test at 12 weeks via M-ICDEP. Data were collected using FSAS, FPAS, OE-ICD, and SB-ICD scales on M-ICDEP. A shock management simulation was conducted at both pre-and post-tests, evaluated with the Shock Management Control Form, and added to shock anxiety data. The control group used M-ICDEP, which includes only one section: summary information, anytime during the 3-month follow-up. The program aimed to reduce shock-related anxiety, increase device acceptance, and enhance self-efficacy. Routine outpatient follow-up was continued for the control group without any other intervention.
Other: Only a two-page summary section of M-ICDEP
The study had three phases: pre-test, implementation, and post-test. Data were collected twice, before the intervention and in the third month, using validated scales and a shock management simulation via the mobile training program (M-ICDEP). M-ICDEP included three sections: an educational section, a two-page summary, and a shock management simulation. Only a two-page summary section were shared with the control group. After the pre-test, control group patients could log in to M-ICDEP anytime using their email and password, accessing the summary section repeatedly during the three-month follow-up. Routine outpatient follow-up was continued for the control group without any other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shock anxiety level
Time Frame: three month
Shock anxiety is measured using the Florida Shock Anxiety Scale (FSAS), which includes 10 items. Scores range from 5 to 50. Higher scores indicate higher levels of shock-related anxiety.
three month
The device acceptance levels
Time Frame: three month
Device acceptance is evaluated with the Florida Patient Acceptance Scale (FPAS), which contains 18 items. The total score ranges from 15 to 75. Higher scores reflect greater acceptance of the implanted cardioverter defibrillator.
three month
Self-efficacy and outcome expectation levels
Time Frame: three month
Self-efficacy and outcome expectations are assessed using the Self-Efficacy and Outcome Expectations Scale, based on the ICD Internet Intervention model. It has two subscales: self-efficacy (16 items) and outcome expectations (7 items). The total score ranges from 7 to 195. Higher scores in both subscales indicate higher self-efficacy and more positive outcome expectations.
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Collaborators

Koç University

Investigators

  • Study Director: Mediha SERT GÖKÇEBEL, Researcher, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2024

Primary Completion (Actual)

December 26, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527
  • 2024.7 (Other Grant/Funding Number: VEHBİ KOÇ FOUNDATION NURSING FUND)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared; however, summary statistics (mean, standard deviation, frequencies, etc.) will be included in the thesis and relevant publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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