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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I38||Endocarditis, valve unspecified, |
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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. |
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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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