Congenital Heart Disease
Conditions
Brief summary
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.
Detailed description
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. Targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. In partnership with diverse parent and clinician stakeholders, the investigators designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep will be delivered through the Nemours App, an accessible tool for telehealth and patient education. The investigators aim to determine whether HEARTPrep modules produce clinically significant improvements on outcomes in mothers expecting a baby with CHD (Proof-of-Concept). This program of research has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.
Interventions
BEHAVIORALHEARTPrep
HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.
Sponsors
Nemours Children's Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life * Partners of participating expectant mothers can also participate together with the mother * Receiving fetal cardiac care at Nemours Children's Health * Speaks English or Spanish fluently * Age 18 or older * Access to a computer, tablet or mobile device with internet access
Exclusion criteria
-Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | Weeks 1, 2, 3, 4, 6 | Assesses depression over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater depression. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of depression and a T-score of 70 and above is indicative of a severe level of depression. |
| Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | Weeks 1, 2, 3, 4, 6 | Assesses anxiety over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater anxiety. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of anxiety and a T-score of 70 and above is indicative of a severe level of anxiety. |
| Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | Weeks 1, 2, 3, 4, 6 | Assesses social isolation over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater social isolation. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of social isolation and a T-score of 70 and above is indicative of a severe level of social isolation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Efficacy Short-Form | Weeks 1, 2, 3, 4, 6 | Assesses feelings of self-efficacy over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater self-efficacy; minimum score = 4; maximum score = 20) |
| Hope Short-Form | Weeks 1, 2, 3, 4, 6 | Assesses feelings of hope over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater hope; minimum score = 4; maximum score = 20) |
Countries
United States
Participant flow
Recruitment details
Recruitment began in July 2023 and ended in March 2025. Perinatal nurse coordinators at Nemours Children's Health provided eligible expectant mothers with information about the research study during fetal cardiology appointments or by phone and directly referred mothers to the study. Expectant mothers were then contacted by a research team member to provide more information about the study and conduct the informed consent process.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18-24 years old | 4 Participants |
| Age, Customized 25-29 years old | 10 Participants |
| Age, Customized 30-34 years old | 11 Participants |
| Age, Customized 35-43 years old | 5 Participants |
| Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | 59.85 T-score STANDARD_DEVIATION 12.89 |
| Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | 58.03 T-score STANDARD_DEVIATION 10.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hope - Short Form | 15.47 Scores on a scale STANDARD_DEVIATION 3.45 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 30 Participants |
| Self-Efficacy - Short Form | 13 Scores on a scale STANDARD_DEVIATION 3.71 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
| Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | 47.98 T-score STANDARD_DEVIATION 8.41 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed