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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05168449
Other study ID # CL (2871)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2022
Est. completion date December 5, 2023

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 5, 2023
Est. primary completion date December 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stages 2-5 of chronic kidney disease - Literate - Ownership of android smart phone compatible with the application - Poly-pharmacy Exclusion Criteria: - On dialysis due to loss of kidney function - Pregnancy due to altered physiology

Study Design


Intervention

Other:
Mobile Application
mobile phone applications directed to chronic kidney disease patients to improve their medication.

Locations

Country Name City State
Egypt Private Clinic Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in medication adherence Using a medication adherence questionnaire. Change from baseline at 3 months
Secondary Change in estimated glomerular filtration rate/ creatinine clearance Calculated using serum creatinine lab results obtained from clinic. Change from baseline at 3 months
Secondary Change in systolic and diastolic blood pressure To be measured in clinic. Change from baseline at 3 months
Secondary Change in HbA1c Lab results obtained from clinic. Change from baseline at 3 months
Secondary Change in mobile application usability and acceptability by patients Using System Usability Scale (SUS) questionnaire. (scale 0-100 with higher score meaning better usability) Change from baseline at 3 months
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