NCT02435693

Brief Summary

Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule Objectives:-

  1. 1.To evaluate Pharmaceutical care program in Type2 diabetics.
  2. 2.To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
  3. 3.To study the prevalence of Type2 diabetics cases in Dhule.
  4. 4.To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
  5. 5.To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
  6. 6.To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus.
  7. 7.To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule.
  8. 8.To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus.
  9. 9.To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.
  10. 10.To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

2.9 years

First QC Date

February 7, 2015

Last Update Submit

November 3, 2015

Conditions

DIABETES MELLITUS, TYPE 2

Keywords

pharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • 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

    24 weeks

Secondary Outcomes (1)

  • Quality of Life score

    24 weeks

Study Arms (2)

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.

Other: PHARMACEUTICAL CARE programe

control

OTHER

without pharmaceutical care programe (control)

Other: Without PHARMACEUTICAL CARE programe

Interventions

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.

PHARMACEUTICAL CARE programe
Without PHARMACEUTICAL CARE programeOTHER
control

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tabrej Aj Mujawar

Dhule, Maharashtra, 424001, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • tabrej aj mujawar, mpharm

    muhs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
tabrej mujawar mpharm Study principal investigator

Study Record Dates

First Submitted

February 7, 2015

First Posted

May 6, 2015

Study Start

July 1, 2012

Primary Completion

June 1, 2015

Study Completion

November 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

IN(1)