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CTRI Number  CTRI/2022/07/044270 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 22/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A randomized control trial to assess the effectiveness of “discharge instructions” for valvular heart surgery patients admitted in Advanced Cardiac Centre, PGIMER Chandigarh 2021-23.  
Scientific Title of Study   A Randomised controlled trial to assess the effectiveness of “self care package” for valvular heart surgery patients admitted in Advanced Cardiac Centre, PGIMER Chandigarh 2021-23.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani 
Designation  M.sc.Nursing  
Affiliation  PGIMER CHANDIGARH 
Address  NATIONAL INSTITUDE OF NURSING EDUCATION ,PGIMER,CHANDIGARH Room.no 208 NINE,PGIMER CHANDIGARH Chandigarh CHANDIGARH India

Chandigarh
CHANDIGARH
160012
India 
Phone  7018552501  
Fax    
Email  shivanichoudhary1196@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MsNeena vir singh 
Designation  Lecturer 
Affiliation  NINE PGIMER CHANDIGARH 
Address  Room.no.212,NINE PGIMER CHANDIGARH Chandigarh 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  8146552482  
Fax    
Email  neenasinghnine@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivani  
Designation  M.sc.Nursing student 
Affiliation  NINE,PGIMER CHANDIGARH 
Address  Room.no.208,NINE PGIMER CHANDIGARH

Chandigarh
CHANDIGARH
160012
India 
Phone  7018552501  
Fax    
Email  shivanichoudhary1196@gmail.com  
 
Source of Monetary or Material Support  
Advanced cardiac centre,PGIMER CHANDIGARH sector-12. 
 
Primary Sponsor  
Name  PGIMER CHANDIGARH INDIA  
Address  NATIONAL INSTITUDE OF NURSING EDUCATION PGIMER CHANDIGARH INDIA 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shivani  CTVS units ACC PGIMER Chandigarh   CTVS units 4 th floor A&B block
Chandigarh
CHANDIGARH 
7018552501

shivanichoudhary1196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I38||Endocarditis, valve unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  "Self care package" for valvular heart surgery patients   self care package will be taught to the patients like how they can adhere to the anticoagulant medications life long,surgical site care,prevention of infection,pre and post sugical care,lifestyle modification and all these intervention help in better improvement.  
Comparator Agent  Control group will be given routine treatment as prescribed by doctor  Control group will be given routine treatment as prescribed by doctor and will be assessed for treatment adherence and complications. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients willing to participate 
 
ExclusionCriteria 
Details  Patients with psychosis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess effectiveness of self care package for valvular heart surgery patients admitted in Advance cardiac centre,PGIMER Chandigarh  Primary outcome will be assessed at 1 week and then 1 month. 
 
Secondary Outcome  
Outcome  TimePoints 
To develop and implement a protocol for self care package for valvular heart surgery patients admitted in Advance cardiac centre PGIMER Chandigarh  Secondary outcome will be assessed at 1 week and then 1 month. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/07/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction and need : Valvular heart disease is a cardiovascular disease process involving one or more of the four valves of the heart .These conditions occur largely as a consequence of aging, but may  also be the result of congenital (inborn) abnormalities or specific disease or physiologic processes including rheumatic heart disease and pregnancy.

Valvular heart disease (VHD) is a major contributor to loss of physical function, quality of life and longevity. The epidemiology of VHD varies substantially around the world, with a predominance of functional and degenerative disease in high-income countries, and a predominance of rheumatic heart disease in low-income and middle-income countries.Valvular heart disease (VHD) is prevalent in developed and developing countries with etiology of degenerative and, surgeries. Rheumatic heart disease burden is highest among the world’s disadvantaged populations. Its prevalence has been rising steadily since 1990, reaching 40.5 million (95% UI, 32.1-50.1 million) currently affected in 2019

Patient education is a planned interactive learning process designed to support and enable patients to manage their life with a disease and/or optimise their health and well-being.With proper education, patients might increase adherence to treatment, lifestyle changes and be able to detect early changes in their clinical condition. Educational and interventional programmes are considered to be vital strategies that can contribute to better health outcomes in patients with cardiac diseases. Proper education helps in decreasing the incidence of complications resulting from the disease and its therapeutic management.

As educational and interventional programme is necessary to reduce anxiety, helps the patients to understand their own disease condition and make patient independent for self-care activities. But presently, in cardiology units of Advance Cardiac Centre, PGIMER Chandigarh, there is no as such programme exist. Therefore there is a need of “self care package” for valvular heart surgery patients. The goal of this “self care package” is to increase patient’s interest and involvement in self care by conveying knowledge and preparing them to manage their own condition.

Objectives :-

q  To develop and implement “self care package” for valvular heart surgery patients admitted for surgery in Advanced Cardiac Centre ,PGIMER, Chandigarh.

q  To assess the effectiveness of “self care package” on selected outcome variables among valvular heart surgery patients admitted in Advanced Cardiac Centre, PGIMER, Chandigarh.

Self care package for valvular  heart surgery patients: 

The protocol will be prepared in the form of booklet containing all information regarding self care like  treatment adherence, surgical site care, life style modification but demonstration for components like  hand washing, deep breathing exercises ,steam inhalation. 


 
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