| CTRI Number |
CTRI/2021/09/036541 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the treatment awareness and self medication behavior along with drugs prescribed in patients of long standing heart failure |
|
Scientific Title of Study
|
Evaluation of Awareness to Drug Treatment, Prescription Pattern & Self-medication practices in patients of Chronic Heart Failure |
| Trial Acronym |
CHF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raakhi K tripathi |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Department of Pharmacology & Therapeutics, Seth G.S. medical College & K.E.M Hospital, Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
lookon@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujeet Bhilwade |
| Designation |
Junior Resident Doctor |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Acharya Donde marg, parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sujeetbhilwade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujeet Bhilwade |
| Designation |
Junior Resident Doctor |
| Affiliation |
Seth GS Medical college and KEM Hospital |
| Address |
Acharya Donde marg, parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
sujeetbhilwade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Raakhi K Tripathi |
| Address |
Department of Pharmacology & Therapeutics, Seth GS Medical college & KEM Hospital, Parel, Mumbai. 400012
|
| Type of Sponsor |
Other [self] |
|
|
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 Sujeet Bhilwade |
Seth GS Medical College & KEM Hospital |
Cardiology OPD, Department of Cardiology , CVTS building
Mumbai
MAHARASHTRA |
7276613562
sujeetbhilwade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-3, Seth GS Medical College & KEM Hospital, Paral, Mumbai 400012 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients with age >18 years, attending Cardiology OPD categorised for Chronic Heart failure with Grade I, II and III as per ACCF/AHA Guideline and willing to give consent.
2. Patients carrying treatment records prescribed at Cardiology OPD of KEM hospital, containing Chronic Heart Failure medication regimen for Grade I, II and III for at least 3 months and willing to give consent
|
|
| ExclusionCriteria |
| Details |
1. Newly diagnosed and treatment-naive patients
2. Patients not willing to give informed consent.
3. Patients admitted in Cardiology IPD and emergency department.
4. Patients with a history of substance dependence or abuse.
5.Critically ill patients requiring urgent attention for medical problems
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness of drug treatment in Chronic Heart Failure patients. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prescription Pattern of drugs used in the treatment of Chronic Heart Failure patients |
12 months |
| assessment of Self-medication practices in patients Chronic Heart Failure |
12 months |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
20/09/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
HF is a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood. In India, the burden of Heart failure appears to be high with an annual incidence of 600- 1.8 million with the prevalence ranging from 1.3 million to 4.6 million. The burden of Chronic Heart Failure is increasing to date there are no studies done in India related to treatment awareness about chronic Heart Failure in these patients, hence a cross-sectional, Observational study is planned to assess the awareness about the treatment of Chronic Heart Failure. The treatment of chronic illness commonly includes the long-term use of pharmacotherapy that led to variability in the prescription pattern. The use of some OTC medications such as NSAIDs and nasal decongestants by individuals with heart failure increases the possibility of exacerbation of Heart failure. No study regarding Self-medication practices in chronic Heart failure patients was done in India. Hence, we would like to undertake this study in patients attending the cardiology OPD, with 11 items pre-validated questionnaire for treatment awareness and 12 items pre-validated questionnaire for self-medication practices. The data collected will be analyzed using descriptive statistics. |