Diabetes Mellitus Type 2IPCDNCT01580904
Impact of Pharmaceutical Care in Diabetics Patients
A study testing Intervention: Pharmaceutical Care in people with Diabetes Mellitus Type 2, run by Universidade Estadual da Paraiba at 1 site in Brazil.
Trial summary
The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Intervention: Pharmaceutical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 30 years,
- diagnosed with type 2 diabetes,
- to make use of oral antidiabetic agents with or without insulin
Who cannot join
- those who had infectious diseases during the research
- missed three consecutive interviews,
- suspended the hypoglycemic drug and medical order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients
The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p <0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Intervention: Pharmaceutical Care
- Keywords
- Pharmaceutical Care, Diabetics patients, Clinical trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Pharmaceutical CareBehavioural
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients will not be followed by the pharmacist. |
| Intervention group | Experimental | Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.
Intervention: Pharmaceutical Care Receives: Behavioral: Intervention: Pharmaceutical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
average glycated hemoglobin over 24 weeks
Measured: Up to 24 weeks
Fasting Glycemia
average fasting glycemia over 24 weeks
Measured: Up to 24 weeks
Secondary outcomes (2)
Total Cholesterol
average total cholesterol over 24 weeks
Measured: Up to 24 weeks
LDL Cholesterol
average LDL cholesterol over 24 weeks
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual da Paraiba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Responsible party
- Principal investigator, Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba
- Investigators
- Ivonete A. Doutorado, Study director, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580904
- Sponsor's protocol ID
- UEParaiba
- Acronym
- IPCD
- Status last verified
- Dec 2016
- First submitted
- 11 Apr 2012
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26.
PubMed 21616627
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients
- ClinicalTrials.gov ID
- NCT01580904
- Acronym / sponsor ID
- IPCD / UEParaiba
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Pharmaceutical Care, Diabetics patients, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidade Estadual da ParaibaUniversity, hospital or other
- Collaborators
- Universidade Federal do Rio Grande do Norte
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Apr 2012 (estimated)
- Results
- Posted 10 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p <0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients will not be followed by the pharmacist. |
| Intervention group | Experimental | Behavioral: Intervention: Pharmaceutical CarePatients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin. Intervention: Pharmaceutical Care |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged 30 years,
- diagnosed with type 2 diabetes,
- to make use of oral antidiabetic agents with or without insulin
Key exclusion criteria (3 listed)
- those who had infectious diseases during the research
- missed three consecutive interviews,
- suspended the hypoglycemic drug and medical order
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 |
|---|---|---|
| Intervention: Pharmaceutical CarePatients will be followed by the pharmacist by the Pharmaceutical Care Practice | Behavioural | Intervention group |
Primary outcome
Glycated Hemoglobin
Time frame: Up to 24 weeks
average glycated hemoglobin over 24 weeks
Fasting Glycemia
Time frame: Up to 24 weeks
average fasting glycemia over 24 weeks
2 secondary outcomes
Total Cholesterol
Time frame: Up to 24 weeks
LDL Cholesterol
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21616627Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26.
- A journal that has a lot of research on this topicLink provided by the sponsor.
- An interesting article on this topicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ivonete A. Doutorado study director
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention: Pharmaceutical Care in people with Diabetes Mellitus Type 2, run by Universidade Estadual da Paraiba at 1 site in Brazil.
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 3 inclusion and 3 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 10 Feb 2017. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glycated Hemoglobin (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01580904, which also lists 1 linked publication.
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 10 Feb 2017.