NCT02895334

Brief Summary

This study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2017

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

September 6, 2016

Last Update Submit

July 10, 2017

Conditions

Congenital Heart Disease

Keywords

CHDCongenital Heart Disease

Outcome Measures

Primary Outcomes (2)

  • Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants

    Stress levels will be measured by the Pediatric Inventory for Parents (PIP) which is a 42-item measure that assesses disease-related parenting stress and asks caregivers to indicate the frequency at which disease-related parenting stressor occurs, and the difficulty-level of each stressor.

    Baseline, Week 18

  • Change in Levels Stress for Caregivers of 2-Ventricle Cardiac Defect Infants

    Stress levels will be measured by the Pediatric Inventory for Parents (PIP) which is a 42-item measure that assesses disease-related parenting stress and asks caregivers to indicate the frequency at which disease-related parenting stressor occurs, and the difficulty-level of each stressor.

    Baseline, Week 18

Secondary Outcomes (5)

  • Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants

    Baseline, Week 18

  • Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants

    Baseline, Week 18

  • Change in Infant Weight for 1-Ventricle Cardiac Defect Infants

    Baseline, Week 18

  • Change in Infant Weight for 2-Ventricle Cardiac Defect Infants

    Baseline, Week 18

  • Number of Unplanned Hospital Admissions

    Week 18

Study Arms (2)

MyHeartBaby

EXPERIMENTAL

Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments.

Behavioral: MyHeartBaby Program

Standard of Care

NO INTERVENTION

Caregivers will complete 4 follow up assessments.

Interventions

MyHeartBaby ProgramBEHAVIORAL

Participating Caregivers will receive an electronic tablet loaded with a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs with video-based telemedicine support services. There are a total of six sessions occurring at weeks 3, 6, 9, 12, and 15 of the study.

MyHeartBaby

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver's infant is less than 45 days of age at time of study enrollment.
  • Caregiver of infant with high-risk, shunt dependent physiology (one or two-ventricle circulation) having just received neonatal surgery for CHD.
  • English is a primary language for caregiver of infant.

You may not qualify if:

  • Caregiver's infant is greater than 45 days of age at time of study enrollment.
  • Not a caregiver of infant with high-risk, shunt dependent physiology having just received neonatal surgery for CHD.
  • English is not a primary language for caregiver of infant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brandon Aylward

    Emory University

    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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 9, 2016

Study Start

July 1, 2015

Primary Completion

April 7, 2017

Study Completion

April 7, 2017

Last Updated

July 12, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)