Diabetes Mellitus, Type 2NCT01525992
A Community Pharmacy-based Program to Improve Management of Diabetes
A study testing Community pharmacist-led diabetes education program in people with Diabetes Mellitus, Type 2, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
In this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Community pharmacist-led diabetes education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIran
- Study dates
- Mar 2012to Sep 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetic patients using oral anti diabetic medications.
- Hemoglobin A1c > 7 within the previous month before recruitment
- Adequate literacy and ability to use the glucometer.
- Signing the informed consent
Who cannot join
- Patients requiring adjunct insulin therapy.
- Patients with concurrent heart failure (stage 4).
- Patients who fast in Ramadan.
- Patients receiving diabetes education in other programs.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran, Tehran Province
About this study
Official title: A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.
In this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care.
Read the detailed description
Diabetes mellitus type 2 is a progressive metabolic disorder that leads to several morbidities and increased mortality and costs. Studies showed that strict control of blood glucose in diabetic patients reduces patients' risk of microvascular complications. Community pharmacies are a well-placed healthcare facility located at the heart of the community with convenient access to pharmacists as health care professionals. Some studies have shown effective interventions led by community and clinical pharmacist in developed countries. In developing countries, little evidence exists about feasibility of implementing community pharmacy-based services to promote medications adherence, self glucose monitoring and self-care in diabetic patients.
This study is a 2 arm randomized controlled trial. Eligible patients are referred to the community pharmacy from an endocrinologist's office. Of 135 type-2 diabetic patients who will be recruited in the study,68 will be randomly allocated to the intervention arm using telephone balanced blocked randomization method.
A community pharmacy-based program will provide training about medications, life style and self-care to the intervention arm. The control arm (67 patients) will receive usual care during the study period.
The primary outcome of this study is measured as change in hemoglobin A1C pre and post intervention. As the secondary outcome, medications adherence, diabetes self-care activity, body mass index and blood pressure are measured.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Community pharmacist-led diabetes education program, Usual care
- Keywords
- Community Pharmacy Services, Pharmacists, Diabetes Mellitus, Diabetes Mellitus, Type 2, Self Care, Randomized Controlled Trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community pharmacist-led diabetes education programBehavioural
A trained pharmacist will counsel each patient based on his/her individual needs about medications, life style and self-care. The pharmacist will use a checklist to document the type of education delivered to each patient. A glucometer is provided for each patient in this arm to monitor blood glucose daily. Three to six visits to the community pharmacy are set during the 6-months study period. At each visit, medication related problems and self-care issues are discussed with the patient and the glucometer test strips are provided for the following month. A telephone call will be made to each patient between visits to ensure adherence to drug therapy and resolve any problems .
Usual careOther
The baseline and 6-month follow-up visits to the community pharmacy will be required. If the physician prefers more visits to his office during the study period, it will be granted. The glucometer and a training session about diabetes self-care will be provide at the end of study for control group patients.
| Study group | Role | What they receive |
|---|---|---|
| Community Pharmacy-based Program | Experimental | Not described Receives: Behavioral: Community pharmacist-led diabetes education program |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Hemoglobin A1c is measured in all patients prior to participating in the study. All patients will be required to take the test again at the end of the study (6 months) .
Measured: Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.
Secondary outcomes (4)
Medication adherence
Medication adherence will be measured using "Morisky Medication Adherence Questionnaire" which will be translated into Farsi.The validity and reliability of the translated questionnaire will be investigated primarily.
Measured: Change from baseline (at the point of recruiting) medication adherence at 6 months.
Self-care activity
Self-care activity will be measured using "Diabetes Self-care Activity Measure" questionnaire which will be translated into Farsi. We will investigate the validity and reliability of the translated questionnaire.
Measured: Change from baseline (at the point of recruiting) Self-care activity at 6 months.
Body Mass Index
Weight (measured in kilograms) divided by square of height (measured in Meters).
Measured: Change from baseline (at the point of recruiting) Body Mass Index at 6 months.
Blood pressure
Measured: Change from baseline (at the point of recruiting) Blood pressure at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Center for Rational Use of Drugs
- Responsible party
- Sponsor
- Investigators
- Kheirollah Gholami, M.Sc, PharmD, Study chair, Tehran University of Medical SciencesZahra Jahangard-Rafsanjani, PharmD, Study director, Tehran University of Medical SciencesArash Rashidian, MD, Ph.D, Principal investigator, Tehran University of Medical SciencesNavid Saadat, MD, Principal investigator, Shahid Beheshti University of Medical SciencesAmir Sarayani, PharmD, MPH, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525992
- Sponsor's protocol ID
- 90-04-156-16161
- Status last verified
- Apr 2014
- First submitted
- 31 Jan 2012
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01525992
- Acronym / sponsor ID
- 90-04-156-16161
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Community Pharmacy Services, Pharmacists, Diabetes Mellitus, Diabetes Mellitus, Type 2, Self Care, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Research Center for Rational Use of Drugs
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Feb 2012 (estimated)
- 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.
In this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care.
Detailed description
Diabetes mellitus type 2 is a progressive metabolic disorder that leads to several morbidities and increased mortality and costs. Studies showed that strict control of blood glucose in diabetic patients reduces patients' risk of microvascular complications. Community pharmacies are a well-placed healthcare facility located at the heart of the community with convenient access to pharmacists as health care professionals. Some studies have shown effective interventions led by community and clinical pharmacist in developed countries. In developing countries, little evidence exists about feasibility of implementing community pharmacy-based services to promote medications adherence, self glucose monitoring and self-care in diabetic patients.
This study is a 2 arm randomized controlled trial. Eligible patients are referred to the community pharmacy from an endocrinologist's office. Of 135 type-2 diabetic patients who will be recruited in the study,68 will be randomly allocated to the intervention arm using telephone balanced blocked randomization method.
A community pharmacy-based program will provide training about medications, life style and self-care to the intervention arm. The control arm (67 patients) will receive usual care during the study period.
The primary outcome of this study is measured as change in hemoglobin A1C pre and post intervention. As the secondary outcome, medications adherence, diabetes self-care activity, body mass index and blood pressure are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Pharmacy-based Program | Experimental | Behavioral: Community pharmacist-led diabetes education program |
| Usual care | Active comparator | Other: Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetic patients using oral anti diabetic medications.
- Hemoglobin A1c > 7 within the previous month before recruitment
- Adequate literacy and ability to use the glucometer.
- Signing the informed consent
Key exclusion criteria (4 listed)
- Patients requiring adjunct insulin therapy.
- Patients with concurrent heart failure (stage 4).
- Patients who fast in Ramadan.
- Patients receiving diabetes education in other programs.
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 |
|---|---|---|
| Community pharmacist-led diabetes education programA trained pharmacist will counsel each patient based on his/her individual needs about medications, life style and self-care. The pharmacist will use a checklist to document the type of education delivered to each patient. A glucometer is provided for each patient in this arm to monitor blood glucose daily. Three to six visits to the community pharmacy are set during the 6-months study period. At each visit, medication related problems and self-care issues are discussed with the patient and the glucometer test strips are provided for the following month. A telephone call will be made to each patient between visits to ensure adherence to drug therapy and resolve any problems . | Behavioural | Community Pharmacy-based Program |
| Usual careThe baseline and 6-month follow-up visits to the community pharmacy will be required. If the physician prefers more visits to his office during the study period, it will be granted. The glucometer and a training session about diabetes self-care will be provide at the end of study for control group patients. | Other | Usual care |
Primary outcome
Hemoglobin A1c
Time frame: Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.
Hemoglobin A1c is measured in all patients prior to participating in the study. All patients will be required to take the test again at the end of the study (6 months) .
4 secondary outcomes
Medication adherence
Time frame: Change from baseline (at the point of recruiting) medication adherence at 6 months.
Self-care activity
Time frame: Change from baseline (at the point of recruiting) Self-care activity at 6 months.
Body Mass Index
Time frame: Change from baseline (at the point of recruiting) Body Mass Index at 6 months.
Blood pressure
Time frame: Change from baseline (at the point of recruiting) Blood pressure at 6 months.
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 17 Apr 2014.
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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.
Kheirollah Gholami, M.Sc, PharmD study chair
Tehran University of Medical Sciences
Zahra Jahangard-Rafsanjani, PharmD study director
Tehran University of Medical Sciences
Arash Rashidian, MD, Ph.D principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community pharmacist-led diabetes education program in people with Diabetes Mellitus, Type 2, run by Tehran University of Medical Sciences at 1 site in Iran.
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 4 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 17 Apr 2014. 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 Iran. 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?
Hemoglobin A1c (time frame: Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 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 17 Apr 2014.