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Clinical Trials/CTRI/2022/07/044270
CTRI/2022/07/044270Not yet recruitingNot Applicable

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.

PGIMER CHANDIGARH INDIA1 site in 1 country60 target enrollmentStarted: July 25, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To assess effectiveness of self care package for valvular heart surgery patients admitted in Advance cardiac centre,PGIMER Chandigarh

Study Overview

Brief Summary

Introduction and need : Valvular heart disease isa cardiovascular disease process involving one or more of the four valves of the heart .Theseconditions occur largely as a consequence of aging, but may  alsobe the result of congenital (inborn)abnormalities or specific disease or physiologic processes including rheumaticheart disease and pregnancy.

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

Patient education is aplanned interactive learning process designed to support and enable patients tomanage their life with a disease and/or optimise their health andwell-being.With proper education, patients mightincrease adherence to treatment,lifestyle changes and be able to detect early changes in their clinical condition. Educational and interventionalprogrammes are considered to be vitalstrategies that can contribute to better health outcomes in patients with cardiac diseases. Propereducation helps in decreasing theincidence of complications resulting from the disease and its therapeutic management.

As educational and interventional programme is necessary to reduce anxiety, helps the patients tounderstand their own disease condition and make patient independent forself-care activities. But presently, in cardiologyunits of Advance Cardiac Centre, PGIMER Chandigarh, there is no assuch programme exist. Therefore there is aneed of “self care package†for valvular heart surgery patients. The goal of this “self care package†is to increasepatient’s interest and involvement in selfcare by conveying knowledge and preparing them to manage their own condition.

Objectives :-q  Todevelop and implement “self care package†for valvular heart surgery patientsadmitted for surgery in AdvancedCardiac Centre ,PGIMER, Chandigarh.

q  Toassess the effectiveness of “self carepackage†on selected outcome variables among valvular heart surgery patientsadmitted 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.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Not Applicable

Eligibility Criteria

Ages
15.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients willing to participate.

Exclusion Criteria

  • Patients with psychosis.

Outcomes

Primary Outcomes

To assess effectiveness of self care package for valvular heart surgery patients admitted in Advance cardiac centre,PGIMER Chandigarh

Time Frame: Primary outcome will be assessed at 1 week and then 1 month.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
PGIMER CHANDIGARH INDIA
Sponsor Class
Research institution and hospital

Study Sites (1)

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