MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Behavioral: MyHeartBaby Program

• Registration Number: NCT02895334
• Lead Sponsor: Emory University

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).

Detailed Description

Caregivers of infants with CHD are at high-risk of anxiety and distress due to the complex daily caregiving demands. Previous research has demonstrated decreased parental stress and more optimal infant developmental outcomes with a psychosocial intervention delivered to caregivers of infants with CHD prior to hospital discharge as well as reduced healthcare use in caregivers who received medical video-consultations during the interstage surgical palliation period. This study will implement a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs. The program is delivered via video chat over the Internet and caregivers will complete questionnaires about general family information, stress, and feeding their infant.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Primary Completion: 2017-04-07
• Study Completion: 2017-04-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MyHeartBaby	MyHeartBaby Program	Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments.

Primary Outcome Measures

Name	Time	Method
Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants	Baseline, Week 18	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.
Change in Levels Stress for Caregivers of 2-Ventricle Cardiac Defect Infants	Baseline, Week 18	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.

Secondary Outcome Measures

Name	Time	Method
Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants	Baseline, Week 18	The confidences in feeding questionnaire has been developed for purposes of this study and has a list of 20 questions that ask caregivers about daily feeding practices, stress associated with feeding, and ability to soothe infant.
Change in Infant Weight for 1-Ventricle Cardiac Defect Infants	Baseline, Week 18	Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits.
Change in Infant Weight for 2-Ventricle Cardiac Defect Infants	Baseline, Week 18	Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits.
Number of Unplanned Hospital Admissions	Week 18	Caregivers will report infant hospital admissions during the study duration.
Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants	Baseline, Week 18	The confidences in feeding questionnaire has been developed for purposes of this study and has a list of 20 questions that ask caregivers about daily feeding practices, stress associated with feeding, and ability to soothe infant.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States