Congenital Heart DiseaseNCT01503307
Parenting After Infant Congenital Heart Defect Diagnosis
An observational study of Congenital Heart Disease, run by Medical College of Wisconsin at 2 sites in United States.
Trial summary
The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the… Read more about this study
- Who is it for?
- Ages Up to 12 weeks
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2009to Jul 2016
- Phase
- Observational
- 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 Up to 12 weeks
- All sexes
- No healthy volunteers
- Child
Study population: In this year-long study, 12 to 16 families (mothers and fathers) will be recruited-6 to 8 of the families from the fetal diagnosis clinic at either Meriter Hospital or Children's Hospital of Wisconsin and 6 to 8 families whose infant is diagnosed soon after birth with a complex CHD at either Meriter Hospital or Children's Hospital of Wisconsin.
Who may be able to join
- at least 18 years old
- English speaking and reading
- not known to have a mental illness or cognitive deficit
- prenatal or postnatal diagnosis of a complex CHD that requires surgical repair or palliation early in the infant's life (i.e., tetralogy of Fallot, atrial-ventricular canal, ventricular septal defect, pulmonary stenosis, tricuspid atresia, hypoplastic right or left heart, or other complex condition). Infants will not be excluded if they also have congenital syndromes or extra-cardiac defects.
Who cannot join
- no CHD diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Madison
Madison, Wisconsin, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.
Read the detailed description
Parental mental health status is linked to the development and quality of caregiving, as well as physiological and psychosocial outcomes for the infant/child with a heart defect.
This is an evolving population of parents with most challenged prenatally with a fetal diagnosis and later as caregivers for medically complex infants. Parents with pre- and postnatally diagnosed infants are at risk for sub-optimal mental health. Parents' experiences and needs differ by timing of diagnosis.
Several gaps in the literature exist. First, advances in technology raise questions about how becoming a caregiver is experienced considering the timing of the diagnosis. Second, little is known about how the timing of the diagnosis could influence parents' mental health status and caregiving after diagnosis. Finally, more study is needed to identify the type, timing and duration of intervention to support these parents as caregivers and optimize their infants' health.
Data collected for this study included demographic and health information (from parents and infant health records), measures of distress (symptoms of depression, anxiety and trauma), and interviews. Semi-structured interviews were conducted with parents in person in the hospital and home settings. Interviews with each couple in the prenatally diagnosed group were conducted once during the third trimester of pregnancy and once within 12 weeks after birth. Interviews with each couple or mother in the postnatally diagnosed group were conducted once within 12 weeks after birth. Interviews lasted 1-3 hours, were audio-recorded and transcribed verbatim for analysis. Field notes were also written and audio recorded for use in analysis.
Directed content analysis has been used to describe parents' experiences and caregiving motivations in relation to parental distress and severity of infant illness. Analysis of data is ongoing. Additional analyses are expected to further improve knowledge on the differing needs of parents of pre- and postnatally diagnosed infants, as well as parents' experiences and caregiving motivations in the context of discharge from tertiary care.
- Conditions
- Congenital Heart Disease
- Keywords
- prenatal chd diagnosis, postpartum chd diagnosis, parenting, internal working models
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prenatal/Postpartum CHD Diagnosis | parent of a baby (prenatal or postpartum)who was recently found to have a heart defect. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a typology of perinatal internal working models of parenting in congenital heart disease.
Qualitative analysis of interviews.
Measured: 1 year
Secondary outcomes (1)
Parent outcomes
Impact of Event Scale - Stress Reactions Center for Epidemiologic Studies Depression Scale - Depression State-Trait Anxiety Inventory - Anxiety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startJan 2009
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin, University of Wisconsin, Madison, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Karen Pridham, PhD, RN, Principal investigator, University of Wisconsin, MadisonAnne C McKechnie, PhD, RN, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503307
- Sponsor's protocol ID
- CHW 08/160
- Other IDs
- GC 728
- Status last verified
- Oct 2019
- First submitted
- 28 Dec 2011
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting After Infant Congenital Heart Defect Diagnosis
- ClinicalTrials.gov ID
- NCT01503307
- Acronym / sponsor ID
- CHW 08/160
- Conditions
- Congenital Heart Disease
- Keywords
- prenatal chd diagnosis, postpartum chd diagnosis, parenting, internal working models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin, University of Wisconsin, Madison, University of Minnesota
- Study start
- Jan 2009 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Jan 2012 (estimated)
- 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.
The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.
Detailed description
Parental mental health status is linked to the development and quality of caregiving, as well as physiological and psychosocial outcomes for the infant/child with a heart defect.
This is an evolving population of parents with most challenged prenatally with a fetal diagnosis and later as caregivers for medically complex infants. Parents with pre- and postnatally diagnosed infants are at risk for sub-optimal mental health. Parents' experiences and needs differ by timing of diagnosis.
Several gaps in the literature exist. First, advances in technology raise questions about how becoming a caregiver is experienced considering the timing of the diagnosis. Second, little is known about how the timing of the diagnosis could influence parents' mental health status and caregiving after diagnosis. Finally, more study is needed to identify the type, timing and duration of intervention to support these parents as caregivers and optimize their infants' health.
Data collected for this study included demographic and health information (from parents and infant health records), measures of distress (symptoms of depression, anxiety and trauma), and interviews. Semi-structured interviews were conducted with parents in person in the hospital and home settings. Interviews with each couple in the prenatally diagnosed group were conducted once during the third trimester of pregnancy and once within 12 weeks after birth. Interviews with each couple or mother in the postnatally diagnosed group were conducted once within 12 weeks after birth. Interviews lasted 1-3 hours, were audio-recorded and transcribed verbatim for analysis. Field notes were also written and audio recorded for use in analysis.
Directed content analysis has been used to describe parents' experiences and caregiving motivations in relation to parental distress and severity of infant illness. Analysis of data is ongoing. Additional analyses are expected to further improve knowledge on the differing needs of parents of pre- and postnatally diagnosed infants, as well as parents' experiences and caregiving motivations in the context of discharge from tertiary care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prenatal/Postpartum CHD Diagnosis | – | –parent of a baby (prenatal or postpartum)who was recently found to have a heart defect. |
Who may qualify
- Ages
- Up to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In this year-long study, 12 to 16 families (mothers and fathers) will be recruited-6 to 8 of the families from the fetal diagnosis clinic at either Meriter Hospital or Children's Hospital of Wisconsin and 6 to 8 families whose infant is diagnosed soon after birth with a complex CHD at either Meriter Hospital or Children's Hospital of Wisconsin.
Key inclusion criteria (4 listed)
- at least 18 years old
- English speaking and reading
- not known to have a mental illness or cognitive deficit
- prenatal or postnatal diagnosis of a complex CHD that requires surgical repair or palliation early in the infant's life (i.e., tetralogy of Fallot, atrial-ventricular canal, ventricular septal defect, pulmonary stenosis, tricuspid atresia, hypoplastic right or left heart, or other complex condition). Infants will not be excluded if they also have congenital syndromes or extra-cardiac defects.
Key exclusion criteria (1 listed)
- no CHD diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a typology of perinatal internal working models of parenting in congenital heart disease.
Time frame: 1 year
Qualitative analysis of interviews.
1 secondary outcome
Parent outcomes
Time frame: 1 year
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 25 Oct 2019.
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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.
Karen Pridham, PhD, RN principal investigator
University of Wisconsin, Madison
Anne C McKechnie, PhD, RN principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Medical College of Wisconsin at 2 sites in United States.
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 4 inclusion and 1 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Creation of a typology of perinatal internal working models of parenting in congenital heart disease. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2019.