Quality of Life in Cardiac Pediatric Patients Attending Assuit Univeristy Hospital

Quality of Life in Cardiac Patients Attending Assuit University Children Hospital

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2)

Study Overview

• Status: Unknown
• Conditions: Quality of Life
• Intervention / Treatment: Behavioral: questionnaire

Detailed Description

Quality of life(QOL) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. Their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) Cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. Multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2) Diagnosis of a life-threatening illness during a child's formative years can have far-reaching effects that ripple through the family and across a lifetime. Infants with complex CHD experience a range of uncommon and painful events, such as separation from their mother at birth, urgent transfer to specialized intensive care, frequent invasive medical procedures, feeding difficultiesand withdrawal from narcotic pain relief. These earlylife experiences can have profound consequences for the developing child, shaping brain development, the body's immune system and responses to stress.(5) From a neurodevelopmental perspective, children with CHD experience greater difficulties compared with their healthy peers. The risk and severity of neurodevelopmental impairment increases with greater CHD complexity, the presence of a genetic disorder or syndrome, and greater psychological stress. During infancy, the most pronounced difficulties occur in motor functioning. By early childhood, studies show that children with complex CHD have an increased risk of neurodevelopmental impairment, in fine and gross motor skills, and language, attention, executive functioning, emotion regulation and behaviour.(7)

• Study Type: Observational
• Enrollment (Anticipated): 45

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Infants of both sex.

• Age :from day one to 18 years.
• Attending Assuit University Children Hospital including NICU, pediatric cardiology department, outpatient clinics.
• Patients diagnosed with congenital heart disease (cyanotic, acyanotic, cardiomyopathy, rheumatic heart).

Description

Inclusion Criteria:

• - Infants of both sex.
• Age :from 2 years to 18 years.
• Attending Assuit University Children Hospital including NICU, pediatric cardiology department, outpatient clinics.
• Patients diagnosed with congenital heart disease (cyanotic, acyanotic, cardiomyopathy, rheumatic heart).

Exclusion Criteria:

• - patients suspected to have congenital heart but excluded on echo diagnosis. patient with any associated lesions (patients have any congenital anomalies with congenital heart like down syndrome)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cyanotic and acyanotic group; questinnaire	Behavioral: questionnaire; questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate quality of life in cardiac pediatric patients	Questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
How to improve quality of life in all cardiac pediatric patients and their families	Questionnaire	1year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Davis CC, Brown RT, Bakeman R, Campbell R. Psychological adaptation and adjustment of mothers of children with congenital heart disease: stress, coping, and family functioning. J Pediatr Psychol. 1998 Aug;23(4):219-28. doi: 10.1093/jpepsy/23.4.219.
• Gee DG, Gabard-Durnam LJ, Flannery J, Goff B, Humphreys KL, Telzer EH, Hare TA, Bookheimer SY, Tottenham N. Early developmental emergence of human amygdala-prefrontal connectivity after maternal deprivation. Proc Natl Acad Sci U S A. 2013 Sep 24;110(39):15638-43. doi: 10.1073/pnas.1307893110. Epub 2013 Sep 9.
• Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: qolicp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No