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CTRI Number  CTRI/2019/02/017516 [Registered on: 07/02/2019] Trial Registered Prospectively
Last Modified On: 06/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Role of Clinical Pharmacist in the healthcare management of Type II Diabetes mellitus patients 
Scientific Title of Study   Role of clinical pharmacist in holistic management of type II Diabetes Mellitus and patient satisfaction of care in medical OP 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs S Sarumathy 
Designation  Assistant professor 
Affiliation  SRM Institute of Science and Technology 
Address  SRM Medical College Hospital and Research Centre SRM Institute of Science and Technology (SRMIST) Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9790535992  
Fax    
Email  saruprabakar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J S Kumar 
Designation  Professor, Department of General Medicine 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre SRM Institute of Science and Technology (SRMIST) Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9840047678  
Fax    
Email  drkumarjs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T M Vijayakumar 
Designation  Associate professor 
Affiliation  SRM Institute of Science and Technology 
Address  SRM Medical College Hospital and Research Centre SRM Institute of Science and Technology (SRMIST) Kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  9003400350  
Fax    
Email  vijaypractice@yahoo.com  
 
Source of Monetary or Material Support  
SRM Institute of Science and Technology 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PAULIN C VARGHESE  SRM Medical College Hospital and Research Centre  Department of General Medicine
Kancheepuram
TAMIL NADU 		 9600054755

angelopsr47@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Proceeding of Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pharmacist counselling along with usual clinical care  Pharmacist provides Patient Counselling on Medication Adherence and Assessment of patient satisfaction of care.At the baseline (during discharge) and at follow up (at 6 months)  
Comparator Agent  Usual Clinical Care  Usual clinical care and assessment of patient satisfaction of care. At baseline (during discharge) and at follow up (At the end of six months) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Known case of Type II Diabetes patients who attended the OP department.
Patient whose HbA1C is ≥ 7
Patients of both genders >18 years of age
 
 
ExclusionCriteria 
Details  Patients who are type 1 diabetes, gestational diabetes and psychiatric illness.
Patients who are not willing to participate in the study
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcomes:
Assessment of patient satisfaction of care
Assessment of medication adherence by MARS scale
 		 Measurement at Baseline visit and at the end of 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes:
Improvement in laboratory parameters(Blood Pressure, Blood glucose, Lipid profile, S Creatinine)
Assesment of knowledge attitude and practice of diabetic patients at baseline and follow up.
To provide general education about diabetes.
 		 Measurement at the baseline visit and at the end of 3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/02/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The term diabetes mellitus describes a metabolic disorder of multiple etiologies characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action or both.
In 2017, there were 451 million (age 18-99 years) people with diabetes worldwide.
 It is predicted that by 2030 diabetes mellitus may afflict up to 79.4 million individuals in India, while China (42.3 million) and the United States (30.3 million) will also see significant increases in those affected by the disease.
The total prevalence of diabetes in adults in India was 8.8 % in the year 2017.
Intensive lifestyle interventions involving a combination of diet and physical activity can delay or prevent diabetes among people at high risk.
Diabetes education and training is of critical importance and should be considered an integral part of diabetes prevention and care.
Available literature suggests that the management of diabetes in India is sub-optimal for the majority of patients. Only 40–50% of individuals achieve the target for glycemic control, while lower numbers achieve targets for blood pressure and lipid control.
Collaboration among physicians, nurses, dieticians, and pharmacists is required to ensure optimum patient care and adequate diabetes management.
International standards for diabetes care have recognized the crucial role of pharmacists in diabetes management.
 There are lack of studies in India that analyze the attitudes and roles of pharmacist in diabetes management. The present study is an attempt in this direction.
 
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