Congenital Heart DiseaseNCT02895334
MyHeartBaby: An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program
A study testing MyHeartBaby Program in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- MyHeartBaby Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 7 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: 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).
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- MyHeartBaby Program
- Keywords
- CHD, Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyHeartBaby ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MyHeartBaby | Experimental | Caregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments. Receives: Behavioral: MyHeartBaby Program |
| Standard of Care | No intervention | Caregivers will complete 4 follow up assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 18
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 18
Number of Unplanned Hospital Admissions
Caregivers will report infant hospital admissions during the study duration.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJul 2015
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Heart Network, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brandon Aylward, Emory University
- Investigators
- Brandon Aylward, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895334
- Sponsor's protocol ID
- IRB00082281
- Status last verified
- Jul 2017
- First submitted
- 6 Sep 2016
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Evaluation of the MyHeartBaby Psychosocial Telemedicine Program
- ClinicalTrials.gov ID
- NCT02895334
- Acronym / sponsor ID
- IRB00082281
- Conditions
- Congenital Heart Disease
- Keywords
- CHD, Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pediatric Heart Network, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2015 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyHeartBaby | Experimental | Behavioral: MyHeartBaby ProgramCaregivers will complete Telehealth Psychosocial Sessions and 4 follow up assessments. |
| Standard of Care | No intervention | –Caregivers will complete 4 follow up assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyHeartBaby ProgramParticipating 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. | Behavioural | MyHeartBaby |
Primary outcome
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.
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.
5 secondary outcomes
Change in Levels of Caregiver Confidence in Feeding Management for 1-Ventricle Cardiac Defect Infants
Time frame: Baseline, Week 18
Change in Levels of Caregiver Confidence in Feeding Management for 2-Ventricle Cardiac Defect Infants
Time frame: Baseline, Week 18
Change in Infant Weight for 1-Ventricle Cardiac Defect Infants
Time frame: Baseline, Week 18
Change in Infant Weight for 2-Ventricle Cardiac Defect Infants
Time frame: Baseline, Week 18
Number of Unplanned Hospital Admissions
Time frame: Week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon Aylward principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyHeartBaby Program in people with Congenital Heart Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Levels Stress for Caregivers of 1-Ventricle Cardiac Defect Infants (time frame: Baseline, Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.