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Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology

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ClinicalTrials.gov Identifier: NCT02462434
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Uzark, University of Michigan

Brief Summary:
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Half of the participants will receive early palliative care team consultation, while the other half will receive usual care (no or late palliative care intervention). The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Hypoplastic Left Heart Syndrome Single Ventricle Defect Stress, Psychological Behavioral: Early palliative care team consultation Not Applicable

Detailed Description:

Mothers of children with congenital heart disease are at increased risk of psychological morbidity including stress, anxiety, and depression. In particular, mothers of patients with single ventricle physiology who require neonatal surgery, face a great deal of stress related to the risk of serious complications including neonatal death. Previous studies have suggested that providing emotional psychosocial support may modify the development of significant psychosocial problems in parents of children with congenital heart disease. The pediatric palliative care team specializes in multiple elements of psychological and spiritual care for families of such children.

The purpose of this pilot study is to evaluate maternal psychological distress and to examine the potential impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates born with single ventricle physiology. Mothers will complete four questionnaires measuring anxiety, depression, and quality of life/family functioning at a prenatal follow up visit and again prior to neonatal surgical hospital stay discharge (or at 30 days). Infants will be randomly assigned (by date of birth) to receive early palliative care team consultation or usual care (no or late palliative care intervention).

The investigators hypothesize maternal stress, anxiety, and depression will be lower in the palliative care intervention group compared with the control group, and maternal coping mechanisms and perceived quality of life and family functioning will improve at the pre-discharge assessment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology Requiring Neonatal Surgery
Study Start Date : April 2013
Actual Primary Completion Date : October 12, 2015
Actual Study Completion Date : November 15, 2016


Arm Intervention/treatment
Experimental: Early palliative care team consultation
Early pediatric palliative care team consultation for single ventricle patients will occur in this group following birth but prior to the first stage palliative surgery.
Behavioral: Early palliative care team consultation
The palliative care team will evaluate the patient and family with the following core palliative care goals in mind: evaluating maternal understanding of their child's diagnosis and eliciting maternal concerns regarding their child's physical symptoms, identifying maternal social support systems and additional life stressors, identifying maternal expectations and hopes for their child's medical care, and assessing maternal fears surrounding their child's diagnosis and medical treatments. Palliative care team support and resources will then be provided in areas of necessity identified for the family. Palliative care team follow up will then be determined based on the level of need identified for each individual study participant.

No Intervention: Usual care
Usual care for single ventricle patients will be provided with palliative care team consultation occurring at any point (if it is determined the child and family would benefit from palliative care consultation) during the child's neonatal hospital stay.



Primary Outcome Measures :
  1. Change in maternal State-Trait Anxiety Index scores [ Time Frame: Up to 4 weeks ]
    Mothers will complete the State-Trait Anxiety Index to assess current anxiety symptoms and trait-like anxiety symptoms (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.

  2. Change in maternal Beck Depression Index II scores [ Time Frame: Up to 4 weeks ]
    Mothers will complete the Beck Depression Index II to assess severity of depressive symptoms (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.

  3. Change in maternal Brief Cope Inventory survey scores [ Time Frame: Up to 4 weeks ]
    Mothers will complete the Brief Cope Inventory to assess a broad range of coping responses (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.

  4. Change in maternal PedsQL Family Impact Module survey scores [ Time Frame: Up to 4 weeks ]
    Mothers will complete the PedsQL Family Impact Module to measure the impact of the child's cardiac diagnosis on the parents and family to indicate parent functioning and overall family functioning (with clinical cut-off scores defined when applicable) at a prenatal follow up visit and again prior to neonatal surgery discharge.


Secondary Outcome Measures :
  1. Length of neonate's intensive care unit (ICU) stay in days [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2 weeks ]
    Continuous days of initial ICU stay from time of admission

  2. Length of neonate's total hospital stay in days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Continuous acute care inpatient hospital days from day of admission until discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers pregnant with fetuses with single ventricle physiology who are planned to undergo staged single ventricle palliative surgery with the first surgery occurring in the neonatal period.

Exclusion Criteria:

  • Mothers with neonates born at a gestational age of less than 32 weeks requiring admission and management in the Neonatal Intensive Care Unit.
  • Mothers with neonates diagnosed with major non-cardiac congenital anomalies requiring additional surgical management beyond cardiac surgery in the neonatal period.
  • Non-English-speaking mothers who are unable to adequately comprehend and respond to survey questions administered as part of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462434


Locations
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United States, Michigan
University of Michigan C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Hayley S Hancock, MD University of Michigan

Publications:

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Responsible Party: Karen Uzark, Associate Professor of Cardiac Surgery and Associate Professor of Pediatric Cardiology, University of Michigan
ClinicalTrials.gov Identifier: NCT02462434    
Other Study ID Numbers: HUM00072957
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Keywords provided by Karen Uzark, University of Michigan:
Pediatric palliative care
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Congenital Abnormalities
Stress, Psychological
Behavioral Symptoms
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases