NCT03324971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2017

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

October 20, 2017

Last Update Submit

August 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Hemoglobin A1c

    measurement of hemoglobin A1c to determine glycemic control.

    3 months

Study Arms (1)

Diabetic patients with non-adherence and poly-pharmacy

EXPERIMENTAL

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

Other: Medications review

Interventions

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.

Diabetic patients with non-adherence and poly-pharmacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All diabetic patients who are eligible by fulfilling all of the following criteria:
  • HGBA1c ≥7 mg/dl.
  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tarek S Abdealziz

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

October 20, 2017

First Posted

October 30, 2017

Study Start

June 2, 2017

Primary Completion

October 2, 2017

Study Completion

December 7, 2017

Last Updated

September 5, 2018

Record last verified: 2018-08

Locations