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Digital Application-Based Nursing Intervention

8. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Martha Helal Roshdy, PhD Cand
  • Telefonnummer: +20102446650
  • E-post: Marthah@aun.edu.eg

Studiesteder

      • Asyut, Egypt, 71515
        • Assiut University Urology Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Medication Adherence
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Patient Self-Management Behaviors
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Magda Ahmed Mohamed, PhD, Faculty of Nursing, Assiut University
  • Studiestol: Rabea Ahmed Gadelkareem, MD, Assiut University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juli 2026

Primær fullføring (Antatt)

15. juli 2027

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1120261453

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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