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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Shock anxiety level — 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.
• The device acceptance levels — 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.
• Self-efficacy and outcome expectation levels — 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.

Trial sites (1)

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