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Completed

NCT Number: NCT02895334

MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

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).

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyHeartBaby Program

Behavioral

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.

Primary outcomes

  1. Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants

    Time frame: 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.

  2. Change in Levels Stress for Caregivers of 2-Ventricle Cardiac Defect Infants

    Time frame: 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 outcomes

  1. Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants

    Time frame: 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.

  2. Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants

    Time frame: 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.

  3. Change in Infant Weight for 1-Ventricle Cardiac Defect Infants

    Time frame: Baseline, Week 18

    Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits.

  4. Change in Infant Weight for 2-Ventricle Cardiac Defect Infants

    Time frame: Baseline, Week 18

    Clinical assessments of weight-for-age percentiles for purposes of study outcomes will be obtained during regularly scheduled clinic visits.

  5. Number of Unplanned Hospital Admissions

    Time frame: Week 18

    Caregivers will report infant hospital admissions during the study duration.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pediatric Heart Network

Registry information

Official study title

An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2016
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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