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NCT03324971 Clinical Trial

Medication Regimen Complexity and Glycemic Control in Patients With Diabetes

Diabetes Mellitus Clinical Trial

Official title:
Effect of Reducing Medication Regimen Complexity on Glycemic Control in Patients With Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03324971
Other study ID # KA-13071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2017
Est. completion date December 7, 2017

Study information
Verified date August 2018
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date December 7, 2017
Est. primary completion date October 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

All diabetic patients who are eligible by fulfilling all of the following criteria:

1. HGBA1c =7 mg/dl.

2. 2) Poly-pharmacy: defined as the use of five or more medications.

3. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Medications review
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.

Locations
Country Name City State
Egypt Cairo university hospitals Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Hemoglobin A1c measurement of hemoglobin A1c to determine glycemic control. 3 months
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