| CTRI Number |
CTRI/2019/04/018861 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Education (patient education to intervention group and not to control group)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ROLE OF CLINICAL PHARMACIST IN CORONARY HEART DISEASE PATIENTS |
|
Scientific Title of Study
|
IMPACT OF PHARMACEUTICAL CARE ON CLINICAL OUTCOMES AND QUALITY OF LIFE FOR CORONARY HEART DISEASE PATIENTS IN A TERTIARY CARE TEACHING HOSPITAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay BC |
| Designation |
Research Scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
NITTE DEEMED TO BE
UNIVERSITY,DEPT OF PHARMACY PRACTICE, DIV- 1 , ROOM
NO- 26
NITTE GULABI SHETTY MEMORIAL INSTITUTE OF
PHARMACEUTICAL SCIENCES, PANEER, DERALAKATTE,
MANGALURU
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7411916036 |
| Fax |
|
| Email |
vinaybc2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay BC |
| Designation |
Research Scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
NITTE DEEMED TO BE
UNIVERSITY,DEPT OF PHARMACY PRACTICE, DIV- 1 , ROOM
NO- 26
NITTE GULABI SHETTY MEMORIAL INSTITUTE OF
PHARMACEUTICAL SCIENCES, PANEER, DERALAKATTE,
MANGALURU
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7975128828 |
| Fax |
|
| Email |
vinaybc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinay BC |
| Designation |
Research Scholar |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
NITTE DEEMED TO BE
UNIVERSITY,DEPT OF PHARMACY PRACTICE, DIV- 1 , ROOM
NO- 26
NITTE GULABI SHETTY MEMORIAL INSTITUTE OF
PHARMACEUTICAL SCIENCES, PANEER, DERALAKATTE,
MANGALURU
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7411916036 |
| Fax |
|
| Email |
vinaybc2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| NGSM Institute of Pharmaceutical Sciences |
|
|
Primary Sponsor
|
| Name |
Nitte University |
| Address |
6th Floor, University Enclave, Medical Sciences Complex
Deralakatte, Mangaluru - 575018 Karnataka, India |
| Type of Sponsor |
Other [Nitte Deemed to be University] |
|
|
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 |
| Vinay BC |
JUSTICE KS HEGDE HOSPITAL |
DEPARTMENT OF
CARDIOLOGY 3, ROOM NUMBER 24, MANGALURU,
KARNATAKA,
INDIA.575018
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7411916036
vinaybc2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE NITTE (Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
pharmaceutical care |
Clinical pharmacist along with other healthcare professionals attend the ward rounds and clinical pharmacist will provide patient counselling on diet, lifestyle and medication.
Duration:one year follow-up will be carried out. |
| Comparator Agent |
usual care |
usual care here only cardiologists and nurses will take care the coronary heart disease patients and clinical pharmacist will not provide any services like patient counselling on diet,lifestyle and medication .
Duration: one year follow-up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above diagnosed with coronary heart disease with or without comorbidities |
|
| ExclusionCriteria |
| Details |
Pregnant patients.
Psychiatric patients.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in blood pressure, total cholesterol, blood glucose,Body mass index,medication adherence |
6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development, validation and readability of patient information leaflet. |
single. |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
05/05/2019 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an interventional study on impact of pharmaceutical care on clinical outcomes and quality of life for coronary heart disease patients in a tertiary care teaching hospital. Objectives of the study: 1) To study the impact on quality of life (QOL) in coronary heart disease patients who have been provided with pharmaceutical care. 2) To study the impact of pharmaceutical care service such as patient counselling, medication review, patient education on clinical outcome.3) Development, validation and readability of patient information leaflet. Study will be conducted inpatients of coronary heart disease with or without comorbidities in cardiology department of a justice kS Hegde Charitable Hospital, Deralakatte Mangalore. Data will be collected from patient case sheets, treatment charts. Quality of life and medication adherence will be assessed by using Mac-new questionnaires and Morisky green levine respectively. Pharmaceutical care services like patient counselling on diet, lifestyle modification and medication improves the clinical outcomes.
|