NCT01941667

Brief Summary

The investigators want to determine if additional, increased contact with infants and families discharged to home after cardiac surgery improves infant and parent outcomes as compared to usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

4.3 years

First QC Date

February 28, 2013

Last Update Submit

September 29, 2017

Conditions

Congenital Heart DiseasePost Cardiac Surgery

Keywords

Congenital Heart DiseaseNeonates and infantsTelehealthVirtual Home Visits

Outcome Measures

Primary Outcomes (1)

  • Parental Stress Score

    Parental Stress will be measured through the use of the total score of Parental Stress Index collected at the completion of the study period for the infant and family, approximately 5 months of infant's life.

    Within 5 months of infant's life

Secondary Outcomes (4)

  • Parental Quality of life Score

    Within 5 months of infant's life

  • Parental Social Isolation Score

    Within 5 months of Infant's life.

  • Weight Gain at 5 months.

    Within 5 months of life

  • Post Traumatic Stress Disorder Symptoms

    Within 5 month's of Infant's Life

Other Outcomes (1)

  • Health Care Resource Utilization

    Within 5 month's of infants life.

Study Arms (2)

Daily Messages, virtual home visits

EXPERIMENTAL

Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level Daily messages requesting weight, intake, pulse ox and pulse are automated Virtual home visits occur twice weekly where the investigators see the infant and families.

Behavioral: Daily Messages, Virtual Home Visits

Usual Care

PLACEBO COMPARATOR

Infants will have usual care as defined by cardiology.

Other: Usual Care

Interventions

Daily Messages, Virtual Home VisitsBEHAVIORAL

Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level Daily messages requesting weight, intake, pulse ox and pulse are automated Virtual home visits occur twice weekly where the investigators see the infant and families.

Daily Messages, virtual home visits
Usual CareOTHER

Usual care as defined by by the Cardiology Department.

Usual Care

Eligibility Criteria

Age2 Weeks - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cardiac surgery within 2.5 weeks of life,
  • Diagnosis of congenital heart disease,
  • Post menstrual age 37 weeks and older;
  • Minimum birth weight 2500 grams,
  • At least one parent speaks and reads English,
  • Anticipated discharge by 21 days of life

You may not qualify if:

  • Cardiomyopathy,
  • Diagnosis of Genetic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of PHiladelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • Lisanti AJ, Golfenshtein N, Min J, Medoff-Cooper B. Early growth trajectory is associated with psychological stress in parents of infants with congenital heart disease, but moderated by quality of partner relationship. J Pediatr Nurs. 2023 Mar-Apr;69:93-100. doi: 10.1016/j.pedn.2022.12.016. Epub 2023 Jan 23.

    PMID: 36696826DERIVED

  • Golfenshtein N, Lisanti AJ, Cui N, Cooper BM. Predictors of Post-traumatic stress symptomology in parents of infants with Congenital Heart Disease post-surgery and after four months. J Pediatr Nurs. 2022 Jan-Feb;62:17-22. doi: 10.1016/j.pedn.2021.11.013. Epub 2021 Nov 25.

    PMID: 34839196DERIVED

  • Medoff Cooper B, Marino BS, Fleck DA, Lisanti AJ, Golfenshtein N, Ravishankar C, Costello JM, Huang L, Hanlon AL, Curley MAQ. Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. Pediatrics. 2020 Sep;146(3):e20200531. doi: 10.1542/peds.2020-0531.

    PMID: 32817266DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Barbara Medoff-Cooper, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

September 13, 2013

Study Start

July 1, 2012

Primary Completion

November 1, 2016

Study Completion

July 1, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

US(2)