| CTRI Number |
CTRI/2025/12/098382 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess whether clinical pharmacist support can improve health outcomes and medication adherence in patients with cardiovascular disease attending a tertiary care hospital. |
|
Scientific Title of Study
|
Impact of Clinical Pharmacist Management Model on Health Outcome and Medication Adherence in Cardiovascular Disease (CVD) Patients attending Tertiary Care Teaching Hospital : A Randomized Clinical Trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shifa N Bojgar |
| Designation |
Post Graduate, Department of Pharmacy Practice |
| Affiliation |
KLE college of Pharmacy Belagavi |
| Address |
KLE college of pharmacy, belagavi 4th floor pharmacy practice department, JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08762435674 |
| Fax |
|
| Email |
shifabojgar080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Karoli |
| Designation |
assistant professor |
| Affiliation |
KLE college of Pharmacy Belagavi |
| Address |
JNMC CAMPUS,KLE college of Pharmacy, pharmacy practice department 4th floor, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9964501059 |
| Fax |
|
| Email |
satishkaroli@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Karoli |
| Designation |
assistant professor |
| Affiliation |
KLE college of Pharmacy Belagavi |
| Address |
JNMC CAMPUS,KLE college of Pharmacy, pharmacy practice department 4th floor, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9964501059 |
| Fax |
|
| Email |
satishkaroli@klepharm.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE College of Pharmacy, Belagavi - 590010 |
| Address |
JNMC CAMPUS, Nehru Nagar, Belagavi, Karnataka 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shifa N Bojgar |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi |
Front Entrance, NH Service Road, Cardiology department 2nd floor Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
8762435674
bojgarshifa13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I110||Hypertensive heart disease with heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education on disease managemant and medicines |
screening patients with high blood pressure and educating them with diet ,physical activity and medication adherence. |
| Comparator Agent |
prescription as per doctor advice no intervention is given |
advising patients with prescriptions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Diagnosed With CVD.
2.Patients With The Age more than 18years.
3.Patients Admitted In General Medicine And Cardiology Department IPD and OPD. |
|
| ExclusionCriteria |
| Details |
1.Pregnant And Lactating Women Will Be Excluded.
2.Psychiatric Patients And Patients Having Terminal Illness Will Be Excluded.
3.Inability Of Patients To Participate Due To Physical Limitations.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Assess The Impact Of Clinical Pharmacist Management Model On Health Outcomes.
2.To Assess Medication Adherence Using Hill-bone Scale.
|
Baseline to one month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Identify Adverse Drug Reactions (ADRs).
|
Baseline to six months |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
11/12/2025 |
| 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="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 randomized clinical trial aims to evaluate the impact of a Clinical Pharmacist Management Model on health outcomes and medication adherence among patients with cardiovascular disease attending a tertiary care teaching hospital. Cardiovascular disease requires long-term therapy, and poor adherence is a major contributor to treatment failure, complications, and repeated hospitalization. Clinical pharmacists play a key role in optimizing drug therapy, educating patients, and monitoring adherence. |