Clinical trial NCT02895334: MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program
Official title: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: CHD
Congenital Heart Disease
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Pediatric Heart Network
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-09-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
measure: Change in Levels Stress for Caregivers of 2-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
measure: Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
measure: Change in Infant Weight for 1-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
measure: Change in Infant Weight for 2-Ventricle Cardiac Defect Infants
timeFrame: Baseline, Week 18
measure: Number of Unplanned Hospital Admissions
timeFrame: Week 18
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Brandon Aylward
role: PRINCIPAL_INVESTIGATOR
References: