Back to resultsThe Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
Primary Purpose
Chronic Kidney Diseases, Adherence, Medication
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mobile Application
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- Private ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
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 will be provided in addition to the usual care, with an access to the mobile application
Outcomes
Primary Outcome Measures
Change in medication adherence
Using a medication adherence questionnaire.
Secondary Outcome Measures
Change in estimated glomerular filtration rate/ creatinine clearance
Calculated using serum creatinine lab results obtained from clinic.
Change in systolic and diastolic blood pressure
To be measured in clinic.
Change in HbA1c
Lab results obtained from clinic.
Change in mobile application usability and acceptability by patients
Using System Usability Scale (SUS) questionnaire. (scale 0-100 with higher score meaning better usability)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05168449
Brief Title
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
Official Title
The Impact of Pharmacist - Led Mobile Application on Medication Adherence and Efficacy in Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Adherence, Medication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group will be provided in addition to the usual care, with an access to the mobile application
Intervention Type
Other
Intervention Name(s)
Mobile Application
Intervention Description
mobile phone applications directed to chronic kidney disease patients to improve their medication.
Primary Outcome Measure Information:
Title
Change in medication adherence
Description
Using a medication adherence questionnaire.
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Change in estimated glomerular filtration rate/ creatinine clearance
Description
Calculated using serum creatinine lab results obtained from clinic.
Time Frame
Change from baseline at 3 months
Title
Change in systolic and diastolic blood pressure
Description
To be measured in clinic.
Time Frame
Change from baseline at 3 months
Title
Change in HbA1c
Description
Lab results obtained from clinic.
Time Frame
Change from baseline at 3 months
Title
Change in mobile application usability and acceptability by patients
Description
Using System Usability Scale (SUS) questionnaire. (scale 0-100 with higher score meaning better usability)
Time Frame
Change from baseline at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaza Gamal, Bsc
Phone
01111011233
Email
shaza.gamal@pharma.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaza Gamal, Bsc
Organizational Affiliation
Teaching Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Clinic
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients
We'll reach out to this number within 24 hrs