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

NCT06935526 | Enrolling By Invitation

• 2 other identifiers: 5272024.7
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Acceptance of Health Care; Nursing; Implantable Cardioverter Defibrillator (ICD); Self-Efficacy; Shock, Cardiogenic

Keywords

Device acceptance; shock anxiety; implantable cardioverter defibrillator; self-efficacy; nursing

Outcome Measures

Primary Outcomes (3)

• Shock anxiety level

  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

  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

  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

Study Arms (2)

The group of mobile education programe

EXPERIMENTAL

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

Standard Treatment Group

ACTIVE COMPARATOR

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

Interventions

The mobile training program and telephone follow-ups OTHER

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.

The group of mobile education programe

Only a two-page summary section of M-ICDEP OTHER

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.

Standard Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Akdeniz University: lead
• Koç University: collaborator

Study Sites (1)

Akdeniz University

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

Related Publications (32)

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Related Links

• 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

MeSH Terms

Conditions

Patient Acceptance of Health Care; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Mediha SERT GÖKÇEBEL, Researcher

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All patients were administered a mobile education program, and the groups to which the patients belonged were not disclosed, ensuring that the patients were blinded. The aim was to achieve single blinding by ensuring that participants were unaware of which group they were assigned to. Additionally, it was planned to minimize bias by not providing information to the person conducting the statistical analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, research assistant

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 20, 2025
• Study Start: September 26, 2024
• Primary Completion: December 26, 2024
• Study Completion: June 30, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)