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NCT00734643 · ClinicalTrials.gov registry record
Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
A clinical trial, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- 213
- Enrollment target
NCT00734643: Completed study, sponsored by Medical College of Wisconsin.
NCT00734643 is a clinical trial that has completed, run by Medical College of Wisconsin. The registered enrollment target is 213 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00734643 has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- 213 participants
- Enrollment target
Study 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. 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: 1. 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. 2. Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes. 3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS. 4. 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2006-06 |
| Est. Completion | 2019-09-05 |
What the finished NCT00734643 record still lists
NCT00734643 is an observational study that tracks outcomes without assigning an intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00734643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00734643 about?
NCT00734643 is a clinical study titled "Family Adaptation Study 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 financ...
What is the current status of trial NCT00734643?
This trial is currently completed. The enrollment target is 213 participants. The study started on 2006-06. Estimated completion is 2019-09-05.
Who is sponsoring clinical trial NCT00734643?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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