MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: MyHeartBaby Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyHeartBaby<br>Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments. | Behavioral: MyHeartBaby Program<br>* 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.<br>|
| No Intervention: Standard of Care<br>Caregivers will complete 4 follow up assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants | 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. | Baseline, Week 18 | 
| Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants | 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. | Baseline, Week 18 | 
| Change in Infant Weight for 1-Ventricle Cardiac Defect Infants | Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits. | Baseline, Week 18 | 
| Change in Infant Weight for 2-Ventricle Cardiac Defect Infants | Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits. | Baseline, Week 18 | 
| Number of Unplanned Hospital Admissions | Caregivers will report infant hospital admissions during the study duration. | Week 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHD, Congenital Heart Disease