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Digital Application-Based Nursing Intervention

8 de julio de 2026 actualizado por: Martha, Assiut University

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

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Martha Helal Roshdy, PhD Cand
  • Número de teléfono: +20102446650
  • Correo electrónico: Marthah@aun.edu.eg

Ubicaciones de estudio

      • Asyut, Egipto, 71515
        • Assiut University Urology Hospital
        • Contacto:
          • Martha Helal Roshdy, PhD Cand
          • Número de teléfono: +201024465650
          • Correo electrónico: Marthah@aun.edu.eg

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental group
Kidney transplant recipients in this single group receive a digital nursing intervention consisting of the MyTherapy mobile application for medication reminders and symptom tracking, accompanied by an illustrated educational booklet in simple Arabic covering essential post-transplant self-care and lifestyle guidelines.
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 signs self-monitoring, and necessary lifestyle modifications.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Medication Adherence
Periodo de tiempo: Baseline, 1 month, and 3 months post-intervention
Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). Total scores range from 0 to 8, where higher scores indicate better adherence levels (high adherence = 8, medium adherence = 6 to <8, low adherence = <6).
Baseline, 1 month, and 3 months post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Patient Self-Management Behaviors
Periodo de tiempo: Baseline, 1 month, and 3 months post-intervention
Self-management will be evaluated using the Self-Management Scale for Kidney Transplant Recipients (KTR-SMS). Total scores range from 24 to 96, with higher scores reflecting greater patient self-management capabilities (high = 71-96, moderate = 55-70, low = 24-54).
Baseline, 1 month, and 3 months post-intervention
Change in Self-Perceived Burden
Periodo de tiempo: Baseline, 1 month, and 3 months post-intervention
The extent to which patients feel their care places a strain on caregivers will be measured using the Self-Perceived Burden Scale. Total scores range from 10 to 50, with higher scores indicating a greater self-perceived burden (high burden = 21-50, low burden = 10-20).
Baseline, 1 month, and 3 months post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Magda Ahmed Mohamed, PhD, Faculty of Nursing, Assiut University
  • Silla de estudio: Rabea Ahmed Gadelkareem, MD, Assiut University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de julio de 2026

Finalización primaria (Estimado)

15 de julio de 2027

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1120261453

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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