| CTRI Number |
CTRI/2024/01/061820 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Patient Counselling] |
| Study Design |
Other |
|
Public Title of Study
|
Optimizing Medication Utilization and Blood Sugar Control through Pharmacy Counseling |
|
Scientific Title of Study
|
Assessment of the effect of Pharmacist-Led Education Program on Medication Adherence and Glycemic Control in a Community -setting |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogendra Shrestha |
| Designation |
Associate Professor |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice,
Venkatramapuram, Tirupathi
Chittoor ANDHRA PRADESH 517561 India |
| Phone |
7348944358 |
| Fax |
|
| Email |
dryogendrastha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tapala Shamitha |
| Designation |
Student |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice,
Venkatramapuram, Tirupathi
Chittoor ANDHRA PRADESH 517561 India |
| Phone |
6302698949 |
| Fax |
|
| Email |
shamitha2101@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
B Sruthi Selva Kumari |
| Designation |
Student |
| Affiliation |
Seven Hills College of Pharmacy (Autonomus) |
| Address |
Department of Pharmacy Practice,
Venkatramapuram, Tirupathi
Chittoor ANDHRA PRADESH 517561 India |
| Phone |
9345744396 |
| Fax |
|
| Email |
sruthi8112001selva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seven Hills College of Pharmacy |
|
|
Primary Sponsor
|
| Name |
Seven Hills College of Pharmacy |
| Address |
Venkatramapuram, Tirupathi, Andhra Pradesh, India--517561 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yogendra Shrestha |
Sri Venkateswara Institute of Medical Sciences |
Department of Pharmacy Practice, seven Hill College of Pharmacy (Autonomous, Venkatramapuram, Tirupati Chittoor ANDHRA PRADESH |
7348944358
dryogendrastha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical Sciences, Tirumala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patient counselling with standard treatment |
Patients counselling will be given to a group along with standard treatment prescribed by treating physician |
| Comparator Agent |
standard treatment without patient counselling |
Patients counselling will not be given to a group along with standard treatment prescribed by treating physician. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants were aged 20 years and older.
2. Patients with a confirmed diagnosis of Type-2 Diabetes Mellitus (DM) and are currently on medication
3. Patients who express a willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Individuals with serious renal conditions
2. Those with hepatic dysfunction
3. Pregnant women.
4. Patients experiencing uncontrolled glycaemic conditions.
5. Individuals with hearing or vision impairments and psychological problems
6.Patients diagnosed with Type-1 diabetes mellitus and gestational diabetes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The study can establish the importance of patient counselling in medical adherence and glycemic control.
2. The study can help to design the strategy to promote medication adherence.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. The study can help to design the strategy to promote medication adherence. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes has become a substantial clinical and public health concern on a global scale, affecting approximately 422 million individuals, equating to a prevalence of 8.5%. India, with over 62 million cases, stands as the second-highest contributor to the global diabetes burden after China, resulting in approximately 1 million annual fatalities. According to the World Health Organization (WHO), diabetes currently holds the ninth position among the leading causes of death globally. Projections suggest that by the year 2030, diabetes may ascend to become the seventh most prevalent cause of mortality. This underscores the increasing significance of diabetes as a public health concern and emphasizes the need for proactive measures to address and mitigate its impact on global health. Effective control of blood sugar levels via appropriate pharmacotherapy is intricately linked to a substantial decrease in complications associated with diabetes. However, ensuring the success of such pharmacotherapy relies heavily on patient adherence to the prescribed medication regimen. Unfortunately, there is a growing concern as patients exhibit non-adherence behaviours, often discontinuing prescribed medications in favour of alternative remedies as highlighted in recent media reports. This shift in medication practices has been observed to correlate with an alarming increase in both mortality and morbidity rates associated with diabetes. This phenomenon underscores the critical need for a scientific exploration of the factors influencing patient adherence and a comprehensive understanding of the consequences, ultimately guiding strategies to mitigate the adverse impacts on diabetes outcomes. |