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NCT Number: NCT07701057

Digital Application-Based Nursing Intervention

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.

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Key information

Conditions

Kidney Transplantation

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Preparatory Phase: Includes initial tool design, expert validation, administrative permissions, and a pilot study on 10% of the sample.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Application-Based Nursing Intervention

Behavioral

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.

Primary outcomes

  1. Change in Medication Adherence

    Time frame: 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).

Secondary outcomes

  1. Change in Patient Self-Management Behaviors

    Time frame: 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).

  2. Change in Self-Perceived Burden

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Martha Helal Roshdy, PhD Cand

CONTACT

[email protected]

+20102446650

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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