DIABETES MELLITUS, TYPE 2pcpNCT02435693
Pharmaceutical Care Program for Type 2 Diabetes Mellitus
A study testing PHARMACEUTICAL CARE programe and Without PHARMACEUTICAL CARE programe in people with DIABETES MELLITUS, TYPE 2, run by TABREJ MUJAWAR at 1 site in India.
Trial summary
Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule Objectives:- 1. To evaluate Pharmaceutical care program in Type2 diabetics. 2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus. 3. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- DIABETES MELLITUS, TYPE 2
- What is being tested?
- PHARMACEUTICAL CARE programe and Without PHARMACEUTICAL CARE programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2012to Nov 2015
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus of either
- Patients with HbA1c more than 7% and
- Patients with blood sugar level more than 140 mg / dl
Who cannot join
- Patient with end stage kidney disease.
- Patient with heart failure.
- Patient with chronic Diabetes problem and orthopedic problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmaceutical Care Program for Type 2 Diabetes Mellitus in Dhule
Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule
Objectives:-
- To evaluate Pharmaceutical care program in Type2 diabetics.
- To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
- To study the prevalence of Type2 diabetics cases in Dhule.
- To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
- To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
- To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus.
- To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule.
- To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus.
- To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.
- To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.
Read the detailed description
To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
To study the prevalence of Type2 diabetics cases in Dhule. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
- Conditions
- DIABETES MELLITUS, TYPE 2
- Being tested
- PHARMACEUTICAL CARE programe, Without PHARMACEUTICAL CARE programe
- Keywords
- pharmaceutical care
- 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.
PHARMACEUTICAL CARE programeOther
The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.
Without PHARMACEUTICAL CARE programeOther
| Study group | Role | What they receive |
|---|---|---|
| PHARMACEUTICAL CARE programe | Experimental | The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems. Receives: Other: PHARMACEUTICAL CARE programe |
| control | Other | without pharmaceutical care programe (control) Receives: Other: Without PHARMACEUTICAL CARE programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded fasting blood glucose
Measured: 24 weeks
Secondary outcomes (1)
Quality of Life score
Quality of Life score
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionNov 2015
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TABREJ MUJAWAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, TABREJ MUJAWAR, R. C. Patel Institute of Pharmaceutical Education & Research
- Investigators
- tabrej aj mujawar, mpharm, Principal investigator, muhs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435693
- Sponsor's protocol ID
- pc
- Acronym
- pcp
- Status last verified
- Nov 2015
- First submitted
- 7 Feb 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmaceutical Care Program for Type 2 Diabetes Mellitus in Dhule
- ClinicalTrials.gov ID
- NCT02435693
- Acronym / sponsor ID
- pcp / pc
- Conditions
- DIABETES MELLITUS, TYPE 2
- Keywords
- pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- TABREJ MUJAWARUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 May 2015 (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.
Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule
Objectives:-
- To evaluate Pharmaceutical care program in Type2 diabetics.
- To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
- To study the prevalence of Type2 diabetics cases in Dhule.
- To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
- To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
- To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus.
- To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule.
- To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus.
- To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.
- To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.
Detailed description
To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
To study the prevalence of Type2 diabetics cases in Dhule. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHARMACEUTICAL CARE programe | Experimental | Other: PHARMACEUTICAL CARE programeThe pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems. |
| control | Other | Other: Without PHARMACEUTICAL CARE programewithout pharmaceutical care programe (control) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus of either
- Patients with HbA1c more than 7% and
- Patients with blood sugar level more than 140 mg / dl
Key exclusion criteria (3 listed)
- Patient with end stage kidney disease.
- Patient with heart failure.
- Patient with chronic Diabetes problem and orthopedic problem
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 |
|---|---|---|
| PHARMACEUTICAL CARE programeThe pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems. | Other | PHARMACEUTICAL CARE programe |
| Without PHARMACEUTICAL CARE programe | Other | control |
Primary outcome
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded
Time frame: 24 weeks
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded fasting blood glucose
1 secondary outcome
Quality of Life score
Time frame: 24 weeks
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 4 Nov 2015.
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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.
tabrej aj mujawar, mpharm principal investigator
muhs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PHARMACEUTICAL CARE programe and Without PHARMACEUTICAL CARE programe in people with DIABETES MELLITUS, TYPE 2, run by TABREJ MUJAWAR at 1 site in India.
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 4 Nov 2015. 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 India. 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?
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded (time frame: 24 weeks). 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 4 Nov 2015.