MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Congenital Heart Disease Clinical Trial

Official title:

An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895334
• Other study ID #: IRB00082281
• Status: Completed
• Phase: N/A
• First received: September 6, 2016
• Last updated: July 10, 2017
• Start date: July 2015
• Est. completion date: April 7, 2017

Study information

• Verified date: July 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 7, 2017
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Unplanned Hospital Admissions	Caregivers will report infant hospital admissions during the study duration.	Week 18