The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients

February 7, 2024 updated by: Shaza Gamal Abdel Fattah Ali Mohamed, Cairo University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Private Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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
Experimental: Intervention Group
Intervention group will be provided in addition to the usual care, with an access to the mobile application
Other: Mobile Application
mobile phone applications directed to chronic kidney disease patients to improve their medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication adherence
Time Frame: Change from baseline at 3 months
Using a medication adherence questionnaire.
Change from baseline at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Shaza Gamal, Bsc, Teaching Assistant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2022

Primary Completion (Actual)

December 5, 2023

Study Completion (Actual)

December 5, 2023

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 23, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL (2871)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Mobile Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe