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

Primary Purpose

Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early palliative care team consultation
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Defects, Congenital focused on measuring Pediatric palliative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan C.S. Mott Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early palliative care team consultation

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in maternal State-Trait Anxiety Index scores
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.
Change in maternal Beck Depression Index II scores
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.
Change in maternal Brief Cope Inventory survey scores
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.
Change in maternal PedsQL Family Impact Module survey scores
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

Length of neonate's intensive care unit (ICU) stay in days
Continuous days of initial ICU stay from time of admission
Length of neonate's total hospital stay in days
Continuous acute care inpatient hospital days from day of admission until discharge

Full Information

First Posted
May 28, 2015
Last Updated
April 14, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02462434
Brief Title
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
Official Title
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology Requiring Neonatal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 12, 2015 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
Keywords
Pediatric palliative care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early palliative care team consultation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early palliative care team consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in maternal State-Trait Anxiety Index scores
Description
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.
Time Frame
Up to 4 weeks
Title
Change in maternal Beck Depression Index II scores
Description
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.
Time Frame
Up to 4 weeks
Title
Change in maternal Brief Cope Inventory survey scores
Description
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.
Time Frame
Up to 4 weeks
Title
Change in maternal PedsQL Family Impact Module survey scores
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Length of neonate's intensive care unit (ICU) stay in days
Description
Continuous days of initial ICU stay from time of admission
Time Frame
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks
Title
Length of neonate's total hospital stay in days
Description
Continuous acute care inpatient hospital days from day of admission until discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayley S Hancock, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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

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