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Набор скоро начнётся NCT07701057

Digital Application-Based Nursing Intervention

Без фазы С лечением Kidney Transplantation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Digital Application-Based Nursing Intervention.
Кому может быть актуально
Состояния в реестре: Kidney Transplantation. Базовые параметры: 20 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Health Outcomes of Digital Application-Based Nursing Intervention in Kidney Transplant Recipients

Обзор

The purpose of this study is to evaluate the effect of a digital application-based nursing intervention on improving health outcomes among kidney transplant recipients. Following kidney transplantation, patients face critical, lifelong challenges that require strict adherence to immunosuppressive therapy and rigorous self-management behaviors to prevent graft rejection and mortality. This study introduces a dual-component nursing intervention comprising an illustrated educational booklet and the implementation of the "MyTherapy" mobile health application. The study aims to determine whether combining tailored patient education with real-time digital medication reminders and symptom tracking can successfully enhance medication adherence, improve daily self-management behaviors, and reduce the self-perceived burden among transplant recipients during their post-operative recovery phase.

Подробное описание

This study utilizes a pre-experimental, one-group pretest-posttest design to evaluate how a digital application-based nursing intervention affects operational health outcomes in kidney transplant recipients. The study is conducted at the outpatient clinic of the Assiut Kidney Transplantation Unit, Assiut University Urology Hospital, Egypt. A purposive sample of 50 adult kidney transplant recipients (aged 20-65 years) who underwent transplantation between June 2024 and June 2026 is recruited. The intervention is systematically carried out across three distinct phases:

1. Preparatory Phase: Includes initial tool design, expert validation, administrative permissions, and a pilot study on 10% of the sample. 2. Implementation Phase: Baseline assessments are conducted using translated standardized tools. Patients and their relatives are then trained on utilizing the "MyTherapy" smartphone application for medication prompts, symptom tracking, and daily logging. Concurrently, patients receive an illustrated educational booklet in simple Arabic covering essential post-transplant care, dietary guidelines, and stress management. 3. Evaluation Phase: The longitudinal effects of the digital nursing intervention are evaluated 1 month and 3 months post-intervention.

The operationalized health outcomes and changes from baseline are measured using four validated instruments: a Patient Assessment Questionnaire (assessing patient demographics, preoperative and intraoperative clinical data, and post-operative complications); the Morisky Medication Adherence Scale (MMAS-8) to measure treatment compliance; the Self-Management Scale for Kidney Transplant Recipients (KTR-SMS) to track vital signs monitoring and daily coping; and the Self-Perceived Burden Scale to assess the psychological strain on caregivers. Statistical analysis of the collected data will be performed using IBM SPSS Statistics software.

Вмешательства

  • Поведенческое Digital Application-Based Nursing Intervention
    A multi-component, digital application-based nursing intervention designed to improve post-transplant health outcomes. The intervention consists of two main components: 1) The MyTherapy smartphone application, utilized by patients to receive tailored medication reminders, track post-operative symptoms, and maintain daily health logs. 2) A comprehensive, illustrated educational booklet written in simple Arabic to guide patients on essential post-transplant self-care, medication compliance, vital

Первичные конечные точки

  • Change in Medication Adherence [Срок оценки: Baseline, 1 month, and 3 months post-intervention]
Вторичные конечные точки (2)
  • Change in Patient Self-Management Behaviors [Срок оценки: Baseline, 1 month, and 3 months post-intervention]
  • Change in Self-Perceived Burden [Срок оценки: Baseline, 1 month, and 3 months post-intervention]

Критерии участия

Критерии включения

  • Adult kidney transplant recipients (aged 20-65 years).
  • Patients transplanted between June 2024 and June 2026 who are currently maintained on regular outpatient follow-up.
  • Patients who have access to a smartphone compatible with the mobile application.

Критерии исключения

  • Patients and family members who are illiterate or unable to use the mobile application effectively due to literacy limitations.
  • Patients with severe cognitive impairment or psychiatric conditions
  • Patients with auditory and visual disorders.
  • Patients with failed graft.
  • Patients who are lost to follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Египет · 1 центр
  • Assiut University Urology Hospital — Asyut

Идентификаторы

NCT: NCT07701057 · 1120261453

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗