Back to resultsMedication Regimen Complexity and Glycemic Control in Patients With Diabetes
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Medications review
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
All diabetic patients who are eligible by fulfilling all of the following criteria:
- HGBA1c ≥7 mg/dl.
- 2) Poly-pharmacy: defined as the use of five or more medications.
- Non- compliance: patients were surveyed with both direct and indirect methods to identify non adherence.
Exclusion Criteria:
Exclusion after recruitment Any patient whose diabetic medications regimen changed after recruitment due to hospitalisation, illness, stress or patients preference, will be excluded.
Sites / Locations
- Cairo university hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diabetic patients with non-adherence and poly-pharmacy
Arm Description
Medications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number.
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1c
measurement of hemoglobin A1c to determine glycemic control.
Secondary Outcome Measures
Full Information
NCT ID
NCT03324971
First Posted
October 20, 2017
Last Updated
August 31, 2018
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03324971
Brief Title
Medication Regimen Complexity and Glycemic Control in Patients With Diabetes
Official Title
Effect of Reducing Medication Regimen Complexity on Glycemic Control in Patients With Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
December 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
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
Polypharmacy is an alarming health issue that is defined as prescription of multiple medications, of which some are redundant or unnecessary. Due to comorbidities, diabetic patients are often prescribed multiple medications. Over prescribing occurs either due to, prescribing medications that are not indicated, continuation of certain medications beyond the time of indication, or prescribing more than one medication with the same effect. Improving glycaemic control is the cornerstone for the prevention and treatment of the diabetic complications.
Detailed Description
Hypothesis In addition to the side effects and cost of the unnecessary medications, the investigators hypothesis is that poly-pharmacy will adversely affect patients' compliance with the necessary medications.The investigators propose that elimination of unnecessary medications might improve patients' compliance and consequently improve glycemic control diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective cohort study .The aim of this study to recruit a cohort of diabetic patients,eliminate unnecessary medications,aiming at improving adherence to anti-diabetic medications.
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetic patients with non-adherence and poly-pharmacy
Arm Type
Experimental
Arm Description
Medications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number.
Intervention Type
Other
Intervention Name(s)
Medications review
Intervention Description
Medications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number.
This is in line with the best practice guidelines.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
measurement of hemoglobin A1c to determine glycemic control.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All diabetic patients who are eligible by fulfilling all of the following criteria:
HGBA1c ≥7 mg/dl.
2) Poly-pharmacy: defined as the use of five or more medications.
Non- compliance: patients were surveyed with both direct and indirect methods to identify non adherence.
Exclusion Criteria:
Exclusion after recruitment Any patient whose diabetic medications regimen changed after recruitment due to hospitalisation, illness, stress or patients preference, will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek S Abdealziz
Organizational Affiliation
Cairo University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Medication Regimen Complexity and Glycemic Control in Patients With Diabetes
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