Chronic Kidney DiseasesNCT05168449
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
A study testing Mobile Application in people with Chronic Kidney Diseases and Adherence, Medication, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the impact of pharmacist led mobile application on adherence and efficacy of medication in chronic kidney disease patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Adherence, Medication
- What is being tested?
- Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2022to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stages 2-5 of chronic kidney disease
- Literate
- Ownership of android smart phone compatible with the application
- Poly-pharmacy
Who cannot join
- On dialysis due to loss of kidney function
- Pregnancy due to altered physiology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Pharmacist - Led Mobile Application on Medication Adherence and Efficacy in Chronic Kidney Disease Patients
The aim of the study is to assess the impact of pharmacist led mobile application on adherence and efficacy of medication in chronic kidney disease patients
Read the detailed description
This is a prospective randomized two group pharmacist-led interventional study that will be conducted in a private nephrology clinic. The study will involve introduction of the mobile phone applications to chronic kidney disease patients to improve their adherence to the prescribed medications.
Recruited patients will be randomly divided in two groups; intervention group and control group, with baseline evaluation of outcomes to be measured.
Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, with an access to the mobile application after a simple training for app usage. Both groups will be followed for a period of 3 months.
The study will include the development, validation and the testing for evaluating the specially designed mobile application.
- Conditions
- Chronic Kidney Diseases, Adherence, Medication
- Being tested
- Mobile Application
- Medical subject headings
- Renal Insufficiency, Chronic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile ApplicationOther
mobile phone applications directed to chronic kidney disease patients to improve their medication.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, with an access to the previously described mobile application |
| Intervention Group | Experimental | Intervention group will be provided in addition to the usual care, with an access to the mobile application Receives: Other: Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication adherence
Using a medication adherence questionnaire.
Measured: Change from baseline at 3 months
Secondary outcomes (4)
Change in estimated glomerular filtration rate/ creatinine clearance
Calculated using serum creatinine lab results obtained from clinic.
Measured: Change from baseline at 3 months
Change in systolic and diastolic blood pressure
To be measured in clinic.
Measured: Change from baseline at 3 months
Change in HbA1c
Lab results obtained from clinic.
Measured: Change from baseline at 3 months
Change in mobile application usability and acceptability by patients
Using System Usability Scale (SUS) questionnaire. (scale 0-100 with higher score meaning better usability)
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start17 Sep 2022
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaza Gamal Abdel Fattah Ali Mohamed, Cairo University
- Investigators
- Shaza Gamal, Bsc, Principal investigator, Teaching Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168449
- Sponsor's protocol ID
- CL (2871)
- Status last verified
- Feb 2024
- First submitted
- 24 Nov 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamal S, Elseasi AMA, Sabry NA, Farid SF. Impact of pharmacist led mobile application on medication adherence and efficacy in chronic kidney disease. NPJ Digit Med. 2025 May 30;8(1):325. doi: 10.1038/s41746-025-01742-8.
PubMed 40447835
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmacist - Led Mobile Application on Medication Adherence and Efficacy in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05168449
- Acronym / sponsor ID
- CL (2871)
- Conditions
- Chronic Kidney Diseases, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 23 Dec 2021 (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 aim of the study is to assess the impact of pharmacist led mobile application on adherence and efficacy of medication in chronic kidney disease patients
Detailed description
This is a prospective randomized two group pharmacist-led interventional study that will be conducted in a private nephrology clinic. The study will involve introduction of the mobile phone applications to chronic kidney disease patients to improve their adherence to the prescribed medications.
Recruited patients will be randomly divided in two groups; intervention group and control group, with baseline evaluation of outcomes to be measured.
Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, with an access to the mobile application after a simple training for app usage. Both groups will be followed for a period of 3 months.
The study will include the development, validation and the testing for evaluating the specially designed mobile application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, with an access to the previously described mobile application |
| Intervention Group | Experimental | Other: Mobile ApplicationIntervention group will be provided in addition to the usual care, with an access to the mobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stages 2-5 of chronic kidney disease
- Literate
- Ownership of android smart phone compatible with the application
- Poly-pharmacy
Key exclusion criteria (2 listed)
- On dialysis due to loss of kidney function
- Pregnancy due to altered physiology
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 |
|---|---|---|
| Mobile Applicationmobile phone applications directed to chronic kidney disease patients to improve their medication. | Other | Intervention Group |
Primary outcome
Change in medication adherence
Time frame: Change from baseline at 3 months
Using a medication adherence questionnaire.
4 secondary outcomes
Change in estimated glomerular filtration rate/ creatinine clearance
Time frame: Change from baseline at 3 months
Change in systolic and diastolic blood pressure
Time frame: Change from baseline at 3 months
Change in HbA1c
Time frame: Change from baseline at 3 months
Change in mobile application usability and acceptability by patients
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 40447835Gamal S, Elseasi AMA, Sabry NA, Farid SF. Impact of pharmacist led mobile application on medication adherence and efficacy in chronic kidney disease. NPJ Digit Med. 2025 May 30;8(1):325. doi: 10.1038/s41746-025-01742-8.
- 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. This study is not recruiting at the moment.
Shaza Gamal, Bsc principal investigator
Teaching Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application in people with Chronic Kidney Diseases and Adherence, Medication, run by Cairo 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in medication adherence (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168449, which also lists 1 linked publication.
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 9 Feb 2024.