Diabetes MellitusNCT03324971
Medication Regimen Complexity and Glycemic Control in Patients With Diabetes
A study testing Medications review in people with Diabetes Mellitus, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Medications review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2017to 7 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion after recruitment Any patient whose diabetic medications regimen changed after recruitment due to hospitalisation, illness, stress or patients preference, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Reducing Medication Regimen Complexity on Glycemic Control in Patients With Diabetes.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Medications review
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medications reviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medications review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
measurement of hemoglobin A1c to determine glycemic control.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start2 Jun 2017
- Primary completion2 Oct 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Samy Abdelziz, Kasr El Aini Hospital
- Investigators
- Tarek S Abdealziz, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324971
- Sponsor's protocol ID
- KA-13071
- Status last verified
- Aug 2018
- First submitted
- 20 Oct 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing Medication Regimen Complexity on Glycemic Control in Patients With Diabetes.
- ClinicalTrials.gov ID
- NCT03324971
- Acronym / sponsor ID
- KA-13071
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients with non-adherence and poly-pharmacy | Experimental | Other: Medications reviewMedications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Exclusion after recruitment Any patient whose diabetic medications regimen changed after recruitment due to hospitalisation, illness, stress or patients preference, will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medications reviewMedications 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. | Other | Diabetic patients with non-adherence and poly-pharmacy |
Primary outcome
Change in Hemoglobin A1c
Time frame: 3 months
measurement of hemoglobin A1c to determine glycemic control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek S Abdealziz principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medications review in people with Diabetes Mellitus, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.