Nurse Visitation for Chronic Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the impact of prenatal and early child home visits by nurses on the long-term health of mothers and their children. It examines two groups: one receives free rides to prenatal check-ups and child development screenings, while the other also receives nurse visits during pregnancy and until the child turns two. Women who are less than 29 weeks pregnant, have never given birth, and face social challenges such as being unmarried or unemployed may be suitable candidates. The trial seeks to determine if these services help prevent chronic diseases in mothers and children. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance maternal and child health services.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have chronic illnesses like hypertensive disorders that require treatment, you may not be eligible to participate.
What prior data suggests that this program of nurse visitation and developmental screening is safe?
Research has shown that nurse visits during pregnancy and early childhood are generally safe and well-received. Studies have found positive health benefits without major safety issues. For example, one study with 742 participants found that children whose mothers had nurse visits were less likely to be obese by age 12. Another study found that these visits reduced negative birth outcomes to 26.9%, which is better than with usual care.
Overall, no significant reports of harmful effects from these nurse visits exist. Instead, they often lead to better pregnancy outcomes and fewer childhood injuries. This suggests that the program is safe for both mothers and their children. These findings can reassure those considering joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores an innovative approach to managing chronic disease through supportive services. Unlike standard care options, which often focus on medical treatments and occasional check-ups, this trial combines free transportation, developmental screening, and nurse visits during pregnancy and early childhood. The nurse-visitation component is particularly promising, as it offers personalized, ongoing support that can address both medical and social needs, potentially improving outcomes for both mothers and children. This holistic approach could pave the way for more comprehensive care models that extend beyond traditional healthcare settings.
What evidence suggests that this trial's treatments could be effective for chronic disease?
This trial will compare two approaches: one arm will provide transportation and developmental screening, while the other will include transportation, screening, and nurse visitation during pregnancy and infancy. Research has shown that nurse visits during pregnancy and early childhood can improve health. Specifically, these programs have been found to lower the risk of death for mothers and prevent deaths from avoidable causes in children. Nurse visits are also associated with lower obesity rates in girls and better mental health and language skills, as reported by mothers. Additionally, these visits can reduce the chances of premature births. This suggests that nurse-visitation programs could effectively support the health of mothers and children.12456
Are You a Good Fit for This Trial?
This trial is for first-time pregnant women under 29 weeks with no severe chronic illnesses. It's aimed at those who have participated in a nurse home visiting program and face socioeconomic challenges, such as being unmarried, having less than a high school education, or being unemployed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prenatal and Early Childhood Home-Visiting
Intensive nurse home-visitation services during pregnancy and through the child's second birthday, including developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.
Long-term Follow-up
Participants are monitored for chronic disease and mortality outcomes approximately 30 years after delivery.
What Are the Treatments Tested in This Trial?
Interventions
- Transportation and Developmental Screening
- Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Medpace, Inc.
Industry Sponsor
Dr. August J. Troendle
Medpace, Inc.
Chief Executive Officer since 1992
MD from the University of Maryland, School of Medicine; MBA from Boston University
Dr. Reinilde Heyrman
Medpace, Inc.
Chief Medical Officer since 2017
MD
University of Rochester
Collaborator