Congenital Heart Disease
Conditions
Keywords
CHD, Congenital Heart Disease
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.
Interventions
BEHAVIORALMyHeartBaby Program
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.
Sponsors
Pediatric Heart Network
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| Number of Unplanned Hospital Admissions | Week 18 | Caregivers will report infant hospital admissions during the study duration. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed