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

Overview

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 will include parents of inpatient newborns in Neonatal Intensive Care Unit (NICU) of Centro Materno Pediátrico (CMP) – Centro Hospitalar Universitário de São João (CHUSJ) with the diagnosis of CHD, between March and October 2019. The inclusion criteria considered will be: I) parents of newborns (up to 28 days) with the diagnosis of CHD; II) newborns hospitalized in NICU of CMP-CHUSJ; III) parents aged ≥ 18 years. Parents of newborns with other 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.

Full Title of Study: “Impact Assessment of a Psychoeducational Intervention in Quality of Life of Parents With Children With Congenital Heart Defects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 29, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: INTERVENTION group (I)
    • Group I will be composed by parents of children with the diagnosis of CHD who will receive a psychoeducational intervention plus usual routines of the Service.
  • No Intervention: CONTROL group (C)
    • Group C will be composed by parents of children with the diagnosis of CHD who will receive the usual routines of the Service. After completing the data collection, the possibility of receiving the psychoeducational intervention under study will be offered to this group.

Clinical Trial Outcome Measures

Primary Measures

  • Changes on parental QoL
    • Time Frame: INTERVENTION group – M1 baseline ( beginning of the study); M2 4 weeks after the intervention and M3 16 weeks after intervention. CONTROL group – M1 beginning of the study; M2 4 weeks after enrollment and M3 16 weeks after enrollment.
    • 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.

Secondary Measures

  • Changes on family impact
    • Time Frame: INTERVENTION group – M1 baseline ( beginning of the study); M2 4 weeks after the intervention and M3 16 weeks after intervention. CONTROL group – M1 beginning of the study; M2 4 weeks after enrollment and M3 16 weeks after enrollment.
    • 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.
  • Changes on perception positive contributions
    • Time Frame: INTERVENTION group – M1 baseline ( beginning of the study); M2 4 weeks after the intervention and M3 16 weeks after intervention. CONTROL group – M1 beginning of the study; M2 4 weeks after enrollment and M3 16 weeks after enrollment.
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Parents of newborns (up to 28 days) with the diagnosis of CHD;
  • Newborns hospitalized in HPI-CHSJ;
  • Parents aged ≥ 18 years.

Exclusion Criteria

  • Parents of newborns with other comorbidities associated with CHD;
  • Parents who do not have good understanding and expression in Portuguese.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade do Porto
  • Collaborator
    • Centro de Investigação em Tecnologias e Serviços de Saúde
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marisa Rodrigues, MD, Principal Investigator, Centro de Investigação em Tecnologias e Serviços de Saúde; Faculdade de Medicina da Universidade do Porto; Centro Hospitalar Universitário de São João
    • Maria Emília Areias, PhD, Study Chair, Instituto Universitário de Ciências da Saúde da Cooperativa do Ensino Superior, Politécnico e Universitário; Unidade de Investigação e Desenvolvimento Cardiovascular do Porto
    • José Carlos Areias, PhD, Study Chair, Faculdade de Medicina da Universidade do Porto; Unidade de Investigação e Desenvolvimento Cardiovascular do Porto
    • Pedro Pereira Rodrigues, PhD, Study Chair, Centro de Investigação em Tecnologias e Serviços de Saúde; Departamento de Medicina da Comunidade Informação e Decisão em Saúde; Faculdade de Medicina da Universidade do Porto
    • Luís Filipe Azevedo, PhD, Study Chair, Centro de Investigação em Tecnologias e Serviços de Saúde; Departamento de Medicina da Comunidade Informação e Decisão em Saúde; Faculdade de Medicina da Universidade do Porto
  • Overall Contact(s)
    • Marisa Rodrigues, MD, +351 934765694, marisaigrodrigues@gmail.com

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