MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

July 10, 2017 updated by: Brandon Aylward, Emory University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyHeartBaby
Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments.
Behavioral: MyHeartBaby 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.
No Intervention: Standard of Care
Caregivers will complete 4 follow up assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 18
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.
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
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.
Baseline, Week 18
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.
Baseline, Week 18
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.
Baseline, Week 18
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.
Baseline, Week 18
Number of Unplanned Hospital Admissions
Time Frame: Week 18
Caregivers will report infant hospital admissions during the study duration.
Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

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

Investigators

  • Principal Investigator: Brandon Aylward, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

April 7, 2017

Study Completion (Actual)

April 7, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00082281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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