- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07701057
Digital Application-Based Nursing Intervention
Health Outcomes of Digital Application-Based Nursing Intervention in Kidney Transplant Recipients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Martha Helal Roshdy, PhD Cand
- Telefonnummer: +20102446650
- E-post: Marthah@aun.edu.eg
Studieorter
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Asyut, Egypten, 71515
- Assiut University Urology Hospital
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Kontakt:
- Martha Helal Roshdy, PhD Cand
- Telefonnummer: +201024465650
- E-post: Marthah@aun.edu.eg
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Medication Adherence
Tidsram: Baseline, 1 month, and 3 months post-intervention
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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).
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Baseline, 1 month, and 3 months post-intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Patient Self-Management Behaviors
Tidsram: Baseline, 1 month, and 3 months post-intervention
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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).
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Baseline, 1 month, and 3 months post-intervention
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Change in Self-Perceived Burden
Tidsram: Baseline, 1 month, and 3 months post-intervention
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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).
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Baseline, 1 month, and 3 months post-intervention
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Magda Ahmed Mohamed, PhD, Faculty of Nursing, Assiut University
- Studiestol: Rabea Ahmed Gadelkareem, MD, Assiut University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 1120261453
Plan för individuella deltagardata (IPD)
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