Impact of Psychoeducation in Quality of Life of Parents With Children With Congenital Heart Defects

Congenital Heart Defects Clinical Trial

Official title:

Impact Assessment of a Psychoeducational Intervention in Quality of Life of Parents With Children With Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724006
• Other study ID #: PPeCHD
• Secondary ID: SFRH/BD/123908/2
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2021
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Congenital heart defects (CHD) are the most common congenital malformations. Despite the progress made in the last decades in diagnosis and treatment, CHD continues to be associated with significant morbidity and mortality. Several studies have shown a reduction in the quality of life (QoL) of parents of children with CHD, which may affect children too. The main research aim is to assess and to understand the impact of a psychoeducational intervention in QoL of parents with newborns with CHD.

We are including parents of inpatient newborns in Neonatal Intensive Care Unit (NICU) of UAG da Mulher e Criança - Centro Hospitalar Universitário de São João (CHUSJ) with the diagnosis of non-syndromic CHD, between March 2019 and February 2020. We also included parents of newborns born at CHUSJ with the diagnosis of non-syndromic CHD, not admited in NICU, between September 2019 and February 2020. The inclusion criteria are: I) parents of newborns (up to 28 days) with the diagnosis of non- syndromic CHD; II) newborns hospitalized in CHUSJ; III) parents aged ≥ 18 years. Parents of newborns with other important co-morbidities associated with CHD and those who do not have good understanding and expression in Portuguese will be excluded.

Parents will be divided in 2 study groups: INTERVENTION group (I) and CONTROL group (C). Group I will receive a psychoeducational intervention in addition to the usual routines of the Service. Group C will receive the usual routines of the Service. The psychoeducational intervention, which consists of 2 sessions lasting 90 minutes each one, will be performed as soon as possible after inclusion in the study. Participants will be evaluated in three moments: M1 beginning of the study; M2 4 weeks after the intervention (I) or after enrollment (C) and M3 16 weeks after intervention/enrollment. The primary outcome will be parental QoL, which will be evaluated through the World Health Organization Quality of Life-Bref (WHOQOL-Bref). The family impact and the perception of positive contributions will be secondary outcomes. These outcome variables will be assessed by the Impact on Family Scale and the Positive Contributions Scale - Kansas Inventory of Parental Perceptions, respectively. A semi-structured interview will be performed after all quantitative data have been collected.

The authors expect to find an increase of QoL and positive contributions and a decrease of family impact in the intervention group comparatively to the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parents of newborns (up to 28 days) with the diagnosis of non-syndromic CHD;

• Newborns hospitalized in CHUSJ;

• Parents aged = 18 years.

Exclusion Criteria:

• Parents of newborns with other important comorbidities associated with CHD;

• Parents who do not have good understanding and expression in Portuguese.

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

Behavioral:
• Psychoeducational intervention
The intervention, prepared by a multidisciplinary team, will consist of two 90 minutes collective sessions (max. 8 families). Sessions will consist of lectures, group discussion and relaxation. The program includes content on the effects of a diagnosis of a congenital anomaly on a child in the parents and in the family, stages of mourning, adaptation process, coping strategies, legislative framework and social protection. This is a non-specific intervention for CHD, where the main focus is the diagnosis of a congenital anomaly. In second session, written support material will be distributed. Participants will be asked to practice relaxation in the next 4 weeks.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário de São João	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Universidade do Porto	Centro de Investigação em Tecnologias e Serviços de Saúde, Fundação para a Ciência e a Tecnologia, Unidade Autónoma de Gestão da Mulher e Criança do Centro Hospitalar Universitário de São João

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on parental QoL	Changes on parental quality of life assessed through World Health Organization Quality of Life-Bref (WHOQOL-Bref). The WHOQOL-Bref instrument is composed by 26 items, which are organized in 4 specific domains: Physical (7 items), Psychological (6 items), Social Relationships (3 items), Environment (8 items) and a general QoL facet (2 items). All items are quoted from 1 to 5. Three items, related to questions posed negatively (Q3, Q4 and Q26), must be reversed (the calculation implies the subtraction of their value to six units). The results are transformed on a scale of 0 to 100. Each domain score is computed through the formula: [(sum of all items - number of items) / (4x number of items)] x 100. Higher scores correspond to better quality of life.	INTERVENTION group - M1: baseline (beginning of the study); M2: 4 weeks after the intervention and M3: 16 weeks after intervention. CONTROL group - M1: baseline; M2: 4 weeks after enrollment and M3: 16 weeks after enrollment.
Secondary	Changes on family impact	Changes on family impact assessed through Revised Impact on Family Scale. Impact on Family Scale evaluates the parents' perception of the impact of the child's chronic health condition in family life. Revised Impact on Family Scale contains 15 items. It is a unidimensional scale that scores overall family impact. This score results from sum of all item responses. The result ranges from 15 to 60. Higher scores are indicative of perceived higher family impact associated with child's health condition.	INTERVENTION group - M1: baseline (beginning of the study); M2: 4 weeks after the intervention and M3: 16 weeks after intervention. CONTROL group - M1: baseline; M2 4 weeks after enrollment and M3 16 weeks after enrollment.
Secondary	Changes on perception positive contributions	Changes on perception positive contributions assessed through Positive Contributions Scale - Kansas Inventory of Parental Perceptions. The Portuguese version of the Positive Contributions Scale - Kansas Inventory of Parental Perceptions is composed by 43 items that assessed 6 dimensions/subscales: 1) Source of Personal Growth and Future Consciousness; 2) Source of Learning Out of Experience; 3) Source of Acceptance and Family Cohesion; 4) Source of Happiness and Affection; 5) Source of Spirituality and 6) Source of Social Network Expansion. The scores of the subscales are computed by the average of the items that composes them. Higher scores indicate a perception of greater positive contributions in the different dimensions.	INTERVENTION group - M1: baseline ( beginning of the study); M2: 4 weeks after the intervention and M3: 16 weeks after intervention. CONTROL group - M1: baseline; M2: 4 weeks after enrollment and M3: 16 weeks after enrollment.

External Links

•   Assessment methods and levels of quality of life of parents with children with congenital abnormalities - systematic review and meta-analysis.
•   Impact of psycho-educational interventions in quality of life of parents of children with chronic diseases - systematic review and meta-analysis.
•   Psycho-educational interventions effectiveness to improve the quality of life of parents of children with congenital abnormalities - systematic review and meta-analysis - systematic review and meta-analysis.