NCT07701057

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026May 2028

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 8, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Digital ApplicationNursing Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Medication Adherence

    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

Secondary Outcomes (2)

  • Change in Patient Self-Management Behaviors

    Baseline, 1 month, and 3 months post-intervention

  • Change in Self-Perceived Burden

    Baseline, 1 month, and 3 months post-intervention

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Behavioral: Digital Application-Based Nursing Intervention

Interventions

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.

Experimental group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Urology Hospital

Asyut, 71515, Egypt

Location

Study Officials

  • Magda Ahmed Mohamed, PhD

    Faculty of Nursing, Assiut University

    STUDY CHAIR
  • Rabea Ahmed Gadelkareem, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Martha Helal Roshdy, PhD Cand

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of medical surgical nursing

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations