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CompletedNCT03324971Updated Sep 5, 2018

Medication Regimen Complexity and Glycemic Control in Patients With Diabetes

An interventional study of Medications review in Diabetes Mellitus, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

  1. HGBA1c ≥7 mg/dl.
    1. Poly-pharmacy: defined as the use of five or more medications.
  2. Non- compliance: patients were surveyed with both direct and indirect methods to identify non adherence.

Exclusion criteria

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Diabetic patients with non-adherence and poly-pharmacy

    Medications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number.

    Other: Medications review

Interventions

  • OtherMedications 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.

05

What researchers measure

Primary outcomes

  1. Change in Hemoglobin A1c

    measurement of hemoglobin A1c to determine glycemic control.

    Time frame: 3 months

06

Study locations

1 site
  • Cairo university hospitals
    Cairo, Egypt
07

Registry details

Key details

Study ID
NCT03324971
Lead sponsor
Kasr El Aini Hospital
Responsible party
Tarek Samy Abdelziz (Senior lecturer, Kasr El Aini Hospital) — Principal investigator
First posted
Oct 30, 2017
Start date
Jun 2, 2017
Primary completion
Oct 2, 2017
Completion
Dec 7, 2017
Last update
Sep 5, 2018

Study contacts

Tarek S Abdealziz
principal investigator · Cairo University Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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