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Pharmaceutical Care Program for Type 2 Diabetes Mellitus (pcp)

Primary Purpose

DIABETES MELLITUS, TYPE 2

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
PHARMACEUTICAL CARE programe
Without PHARMACEUTICAL CARE programe
Sponsored by
TABREJ MUJAWAR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for DIABETES MELLITUS, TYPE 2 focused on measuring pharmaceutical care

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient with end stage kidney disease.
  • Patient with heart failure.
  • Patient with chronic Diabetes problem and orthopedic problem

Sites / Locations

  • Tabrej Aj Mujawar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PHARMACEUTICAL CARE programe

control

Arm Description

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 programe (control)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life score
Quality of Life score

Full Information

First Posted
February 7, 2015
Last Updated
November 3, 2015
Sponsor
TABREJ MUJAWAR
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1. Study Identification

Unique Protocol Identification Number
NCT02435693
Brief Title
Pharmaceutical Care Program for Type 2 Diabetes Mellitus
Acronym
pcp
Official Title
Evaluation of Pharmaceutical Care Program for Type 2 Diabetes Mellitus in Dhule
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
TABREJ MUJAWAR

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DIABETES MELLITUS, TYPE 2
Keywords
pharmaceutical care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PHARMACEUTICAL CARE programe
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Other
Arm Description
without pharmaceutical care programe (control)
Intervention Type
Other
Intervention Name(s)
PHARMACEUTICAL CARE programe
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Without PHARMACEUTICAL CARE programe
Primary Outcome Measure Information:
Title
Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Quality of Life score
Description
Quality of Life score
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Inclusion Criteria: 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 Exclusion Criteria: Patient with end stage kidney disease. Patient with heart failure. Patient with chronic Diabetes problem and orthopedic problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tabrej aj mujawar, mpharm
Organizational Affiliation
muhs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tabrej Aj Mujawar
City
Dhule
State/Province
Maharashtra
ZIP/Postal Code
424001
Country
India

12. IPD Sharing Statement

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Pharmaceutical Care Program for Type 2 Diabetes Mellitus

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