跳至主要内容
临床试验/NCT06935526
NCT06935526Enrolling By Invitation不适用

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

Akdeniz University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2024年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
88
试验地点
1
主要终点
Shock anxiety level

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: The mobile training program and telephone follow-ups (Other)

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.

干预措施: Only a two-page summary section of M-ICDEP (Other)

结局指标

主要结局

Shock anxiety level

时间窗: 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.

Self-efficacy and outcome expectation levels

时间窗: 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.

The device acceptance levels

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mediha SERT

Principal Investigator, research assistant

Akdeniz University

研究点 (1)

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