Kidney TransplantationNCT07701057
Digital Application-Based Nursing Intervention
A study testing Digital Application-Based Nursing Intervention in people with Kidney Transplantation, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Digital Application-Based Nursing Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Urology Hospital
Asyut, 71515
Martha Helal Roshdy, PhD Cand, +201024465650, Marthah@aun.edu.eg
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Kidney Transplantation
- Being tested
- Digital Application-Based Nursing Intervention
- Keywords
- Digital Application, Nursing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Application-Based Nursing InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Application-Based Nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1 month, and 3 months post-intervention
Secondary outcomes (2)
Change in Patient Self-Management Behaviors
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).
Measured: Baseline, 1 month, and 3 months post-intervention
Change in Self-Perceived Burden
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).
Measured: Baseline, 1 month, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha, Assiut University
- Investigators
- Magda Ahmed Mohamed, PhD, Study chair, Faculty of Nursing, Assiut UniversityRabea Ahmed Gadelkareem, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701057
- Sponsor's protocol ID
- 1120261453
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Digital Application-Based Nursing Intervention in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07701057
- Acronym / sponsor ID
- 1120261453
- Conditions
- Kidney Transplantation
- Keywords
- Digital Application, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Digital Application-Based Nursing InterventionKidney 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Application-Based Nursing InterventionA 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. | Behavioural | Experimental group |
Primary outcome
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).
2 secondary outcomes
Change in Patient Self-Management Behaviors
Time frame: Baseline, 1 month, and 3 months post-intervention
Change in Self-Perceived Burden
Time frame: Baseline, 1 month, and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magda Ahmed Mohamed, PhD study chair
Faculty of Nursing, Assiut University
Rabea Ahmed Gadelkareem, MD study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Application-Based Nursing Intervention in people with Kidney Transplantation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Helal Roshdy, PhD Cand (+20102446650, Marthah@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence (time frame: Baseline, 1 month, and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.