Mobile Education and Telephone Monitoring for ICD Patients: Effects on Anxiety, Acceptance, and Self-Efficacy
NCT ID: NCT06935526
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
88 participants
INTERVENTIONAL
2024-09-26
2025-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Not using the mobile application regularly (frequency of use monitored by the application)
18 Years
ALL
No
Sponsors
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Koç University
OTHER
Akdeniz University
OTHER
Responsible Party
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Mediha SERT
Principal Investigator, research assistant
Principal Investigators
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Mediha SERT GÖKÇEBEL, Researcher
Role: STUDY_DIRECTOR
Akdeniz University
Locations
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Akdeniz University
Antalya, Konyaaltı, Turkey (Türkiye)
Countries
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References
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Related Links
Access external resources that provide additional context or updates about the study.
American Heart Association (AHA). (2022a). Devices that may ınterfere with ICDs and pacemakers
American Heart Association. (AHA) (2022b). Implantable cardioverter defibrillator (ICD)
American Heart Association. (AHA) (2022c). Living with your ımplantable cardioverter defibrillator (ICD)
NHLBI- National Heart, Lung, and Blood Institute, Defibrillators
WHO, We Are Social \& Hootsuite. Digital 2022 global overwiev report. 2022
Other Identifiers
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2024.7
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
527
Identifier Type: -
Identifier Source: org_study_id
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