NCT04354844

Brief Summary

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 9, 2020

Last Update Submit

April 17, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate quality of life in cardiac pediatric patients

    Questionnaire

    1 year

Secondary Outcomes (1)

  • How to improve quality of life in all cardiac pediatric patients and their families

    1year

Study Arms (1)

Cyanotic and acyanotic group

questinnaire

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

questionnaire

Cyanotic and acyanotic group

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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).

You may qualify if:

  • \- 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).

You may not qualify if:

  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 9718895BACKGROUND
  • 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.

    PMID: 24019460BACKGROUND
  • 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.

    PMID: 22851541BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 21, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

April 21, 2020

Record last verified: 2020-04