| CTRI Number |
CTRI/2025/02/080235 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Social Pharmacy Approach for medicine use for Diabetes in Udupi community. |
|
Scientific Title of Study
|
Development of a Public Health Pharmacy Model for Medication Therapy Management for Type 2 Diabetes Mellitus in Outpatient Settings at Udupi District |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zuha Shyma |
| Designation |
Ph D Research Scholar |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MAHE, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MCODS, 4th floor, KMC, new OPD block, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8861117897 |
| Fax |
|
| Email |
zuha.mcopsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonal sekhar M |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MAHE, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MCODS, 4th floor, KMC, new OPD block, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sonal sekhar M |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MAHE, Manipal |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Science, MCODS, 4th floor, KMC, new OPD block, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
7411338846 |
| Fax |
|
| Email |
sonal.sekhar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Pharmaceutical Science, Manipal Academy of Higher Education, Manipal. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Zuha Shyma |
Manipal College of Pharmaceutical science. |
Department of Pharmacy Practice, Manipal College of Pharmaceutical College, MCODS, 4th floor, KMC, OPD new block, Manipal.
Udupi
KARNATAKA |
8861117897
zuha.mcopsmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community Pharmacist, General Practitioners and Pharmacy students
|
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational intervention |
Interventions include various communication channels and novel educational strategies such as continuous education programs, providing drug information materials, and community outreach programs. Educational intervention will be provided telephonically or in person based on patient convenience. Intervention will be given for 6 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
For Phase I, III, and IV: General Practitioners (GPs), community pharmacists, and outpatients with diabetes mellitus visiting community pharmacies and GP clinics
For Phase II: 5th year Pharm D and 1st year M pharm in pharmacy practice. |
|
| ExclusionCriteria |
| Details |
For Phase I, III, and IV:: General Practitioners (GPs), community pharmacists, and outpatients with diabetes mellitus visiting community pharmacies and GP clinics
For Phase II: Students not willing to participate |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of a new Public Health Pharmacy model for MTM services on outpatient |
Baseline, 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Capacity building among pharmacy students, community pharmacists, & general practitioners. |
Baseline, 2 years |
| Improved self-management skills among diabetes mellitus patients. |
Baseline, 2 years |
|
|
Target Sample Size
|
Total Sample Size="569"
Sample Size from India="569"
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)
|
01/03/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is an operational research study with multiple study designs following a sequential approach that will be enforced in phases (Phase I to IV). In Phase 1, a situation analysis will be conducted at General Practitioner clinics and retail pharmacies to assess the current state of management for diabetes mellitus in outpatient settings using standardized patient (SP) methodology and a point prevalence survey. The patients will be recruited from multiple sites (144 pharmacies and 105 clinics) for 1 year till the calculated sample size is achieved. In Phase 2, a Public Health Pharmacy (PHP) model will be developed, and experts will design a comprehensive PHP course focused on medication therapy management (MTM) for type II diabetes mellitus. In Phase 3, the PHP model will be implemented by providing educational interventions to General practitioners and pharmacists in MTM and patients to enhance self-management skills. Interventions include various communication channels and novel educational strategies such as continuous education programs, providing drug information materials, and community outreach programs. In Phase 4, The implemented PHP model-based interventions will be evaluated 1-2 months post-intervention by reassessing the Phase I study. Point prevalence surveys and SP methods will be used to measure improvements. Direct observations and interviews will be conducted with healthcare providers and patients to evaluate the effectiveness of MTM interventions and identify areas for further refinement.
|