| CTRI Number |
CTRI/2018/05/014047 [Registered on: 22/05/2018] Trial Registered Prospectively |
| Last Modified On: |
16/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Nursing interventions for Heart failure patients |
|
Scientific Title of Study
|
An operational study to develop and evaluate the effectiveness of a Nursing Protocol for the management of patients suffering from Heart Failure on selected parameters attending OPD of Advanced Cardiac Centre, PGIMER, Chandigarh, 2017-19.
|
| Trial Acronym |
HFNP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bandna Kumari |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Room no. 208, National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437326926 |
| Fax |
|
| Email |
bandna76pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhpal Kaur |
| Designation |
Lecturer in Nursing |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Room no. 121, National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
|
| Email |
drsukhpalkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bandna Kumari |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Room no. 1040-41, Department of Cardiology, Advance cardiac Centre PGIMER Chandigarh
Room no. 208, National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437326926 |
| Fax |
|
| Email |
bandna76pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Advance Cardiac Centre |
| Address |
Post Graduate Institute of Medical education and research Sector 12 Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Nursing Education |
National Institute of Nursing Education PGIMER sector 12 Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bandna Kumari |
Post Graduate Institute of Medical Education and Research Chandigarh |
room no. 1040-41, Department of Cardiology Advance Cardiac Centre
Chandigarh
CHANDIGARH |
8437326926
bandna76pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The patients of heart failure with NYHA class I to class IV requiring frequent monitoring at OPDs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
All the patients meeting inclusion criteria will be taken as subjects for interventions. No control will be there |
Structured teaching program regarding self management of heart failure, demonstrations of exercises |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
all patients of heart failure with NYHA class I to ambulatory class IV with ejection fraction less than 40% at the time of enrolment in the study |
|
| ExclusionCriteria |
| Details |
Patients of unsound mind and have unstable heart failure |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Adherence to medications,
Frequency of hospitalisation,
Compliance to dietary regimen,
Exercise tolerance
Quality of life |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
3 months |
| Satisfaction of patient with the nursing interventions |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/07/2018 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An operational study is planned to be conducted on heart failure patients meeting the inclusion criteria in Advance Cardiac Centre PGIMER Chandigarh in the month of July to October 2018. Participants will be chosen purposively. Pilot study will be conducted on 10 % of the participants to see the feasibility. Guidelines will be made and implemented for self management of heart failure patients by themselves. Outcome variables are hospital readmissions due to heart failure, adherence to medications, compliance to dietary regimen, exercise tolerance and quality of life. |