Congenital Heart DefectsNCT03724006
Impact of Psychoeducation in Quality of Life of Parents With Children With Congenital Heart Defects
A study testing Psychoeducational intervention in people with Congenital Heart Defects, run by Universidade do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Psychoeducational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Mar 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parents of newborns (up to 28 days) with the diagnosis of non-syndromic CHD;
- Newborns hospitalized in CHUSJ;
- Parents aged ≥ 18 years.
Who cannot join
- Parents of newborns with other important comorbidities associated with CHD;
- Parents who do not have good understanding and expression in Portuguese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Assessment of a Psychoeducational Intervention in Quality of Life of Parents With Children With Congenital Heart Defects
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.
Read more
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.
- Conditions
- Congenital Heart Defects
- Being tested
- Psychoeducational intervention
- Keywords
- Congenital Heart Defects, Diagnosis, Parents, Quality of Life, Education
- Medical subject headings
- Heart Defects, Congenital, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION group (I) | Experimental | 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. Receives: Behavioral: Psychoeducational intervention |
| CONTROL group (C) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start7 Mar 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 intervention will be performed as soon as possible after inclusion in the study. Participants will be evaluated in 3 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 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Centro Hospitalar De São João, E.P.E., Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- 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 JoãoMaria 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 PortoJosé Carlos Areias, PhD, Study chair, Faculdade de Medicina da Universidade do Porto; Unidade de Investigação e Desenvolvimento Cardiovascular do PortoPedro 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 PortoLuís 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724006
- Sponsor's protocol ID
- PPeCHD
- Other IDs
- SFRH/BD/123908/2016
- Status last verified
- Jul 2021
- First submitted
- 26 Oct 2018
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodrigues MG, Rodrigues JD, Moreira JA, Clemente F, Dias CC, Azevedo LF, Rodrigues PP, Areias JC, Areias ME. A randomized controlled trial to assess the impact of psychoeducation on the quality of life of parents with children with congenital heart defects-Quantitative component. Child Care Health Dev. 2024 Jan;50(1):e13199. doi: 10.1111/cch.13199. Epub 2023 Nov 15.
PubMed 37967565
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment of a Psychoeducational Intervention in Quality of Life of Parents With Children With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03724006
- Acronym / sponsor ID
- PPeCHD
- Conditions
- Congenital Heart Defects
- Keywords
- Congenital Heart Defects, Diagnosis, Parents, Quality of Life, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Centro Hospitalar De São João, E.P.E., Fundação para a Ciência e a Tecnologia
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 intervention will be performed as soon as possible after inclusion in the study. Participants will be evaluated in 3 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 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.
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION group (I) | Experimental | Behavioral: Psychoeducational interventionGroup 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. |
| CONTROL group (C) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of newborns (up to 28 days) with the diagnosis of non-syndromic CHD;
- Newborns hospitalized in CHUSJ;
- Parents aged ≥ 18 years.
Key exclusion criteria (2 listed)
- Parents of newborns with other important comorbidities associated with CHD;
- Parents who do not have good understanding and expression in Portuguese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducational interventionThe 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. | Behavioural | INTERVENTION group (I) |
Primary outcome
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: baseline; 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.
2 secondary outcomes
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: baseline; M2 4 weeks after enrollment and M3 16 weeks after enrollment.
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: baseline; M2: 4 weeks after enrollment and M3: 16 weeks after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 37967565Rodrigues MG, Rodrigues JD, Moreira JA, Clemente F, Dias CC, Azevedo LF, Rodrigues PP, Areias JC, Areias ME. A randomized controlled trial to assess the impact of psychoeducation on the quality of life of parents with children with congenital heart defects-Quantitative component. Child Care Health Dev. 2024 Jan;50(1):e13199. doi: 10.1111/cch.13199. Epub 2023 Nov 15.
- Assessment methods and levels of quality of life of parents with children with congenital abnormalities - systematic review and meta-analysis.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Impact of psycho-educational interventions in quality of life of parents of children with chronic diseases - systematic review and meta-analysis.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational intervention in people with Congenital Heart Defects, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: baseline; M2: 4 weeks after enrollment and M3: 16 weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03724006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.