Hypoplastic Left Heart SyndromeNCT00734643
Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
An observational study of Hypoplastic Left Heart Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to 5 Sep 2019
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period will be eligible to participate. Parents unable to speak or read English will be excluded. An attempt will be made to obtain consent for participation from both the mother and father of the affected infant. If no father is involved in the care of the infant, measures will be obtained from mothers alone. The model will be tested using mothers' reports of family variables. Single parents will be able to participate but will not be included in comparisons between mothers and fathers. Nurse coordinators at participating centers will conduct subject screening and consenting.
Who may be able to join
- Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period
Who cannot join
- Parents unable to speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53129
About this study
Official title: Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, \& McCubbin, 1996) is the theoretical framework that guides this research.
Hypotheses:
- Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.
- Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.
- Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.
- Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.
- Conditions
- Hypoplastic Left Heart Syndrome
- Keywords
- Hypoplastic Left Heart Syndrome, Family coping, Complex Congenital Heart Disease
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Adaptation
Family adaptation will be measured with the general functioning scale of the Family Assessment Device (FAD) (Miller, Epstein, Bishop \& Keitner, 1985) at T1, T2 and T3. The FAD provides an overall measure of family functioning; 12 items, reliability alpha = .83-.86.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2011
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies 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
- 213 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, American Nurses Foundation, Columbia University, Boston Children's Hospital, University of Michigan, Children's Hospital of Philadelphia, Johns Hopkins All Children's Hospital, Medical University of South Carolina, Arkansas Children's Hospital Research Institute, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Kathleen A Mussatto, PhD, RN, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734643
- Sponsor's protocol ID
- CHW 06/117
- Status last verified
- Jan 2020
- First submitted
- 13 Aug 2008
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
- ClinicalTrials.gov ID
- NCT00734643
- Acronym / sponsor ID
- CHW 06/117
- Conditions
- Hypoplastic Left Heart Syndrome
- Keywords
- Hypoplastic Left Heart Syndrome, Family coping, Complex Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital and Health System Foundation, Wisconsin, American Nurses Foundation, Columbia University, Boston Children's Hospital, University of Michigan, Children's Hospital of Philadelphia, Johns Hopkins All Children's Hospital, Medical University of South Carolina, Arkansas Children's Hospital Research Institute, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Study start
- Jun 2006
- Primary completion
- May 2011 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 14 Aug 2008 (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.
Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, \& McCubbin, 1996) is the theoretical framework that guides this research.
Hypotheses:
- Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.
- Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.
- Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.
- Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period will be eligible to participate. Parents unable to speak or read English will be excluded. An attempt will be made to obtain consent for participation from both the mother and father of the affected infant. If no father is involved in the care of the infant, measures will be obtained from mothers alone. The model will be tested using mothers' reports of family variables. Single parents will be able to participate but will not be included in comparisons between mothers and fathers. Nurse coordinators at participating centers will conduct subject screening and consenting.
Key inclusion criteria (1 listed)
- Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period
Key exclusion criteria (1 listed)
- Parents unable to speak or read English
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
Family Adaptation
Time frame: 14 months
Family adaptation will be measured with the general functioning scale of the Family Assessment Device (FAD) (Miller, Epstein, Bishop \& Keitner, 1985) at T1, T2 and T3. The FAD provides an overall measure of family functioning; 12 items, reliability alpha = .83-.86.
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 29 Jan 2020.
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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.
Kathleen A Mussatto, PhD, RN principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoplastic Left Heart Syndrome, run by Medical College of Wisconsin at 1 site 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 1 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 29 Jan 2020. 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 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?
Family Adaptation (time frame: 14 months). 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 29 Jan 2020.