MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Emory University

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Behavioral: MyHeartBaby Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02895334

IRB00082281

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

MyHeartBaby

Experimental group

Description:

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

Treatment:

Behavioral: MyHeartBaby Program

Standard of Care

No Intervention group

Description:

Caregivers will complete 4 follow up assessments.