Nurse Visitation for Chronic Disease

Overseen By Anna Lindberg, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Hypertension, Cardiac disease, Uterine fibroids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

1138 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transportation and Developmental Screening, Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy?

Research shows that nurse-supervised neonatal transport teams provide care comparable to physician-supervised teams, with significant improvements in the condition of infants during transport. This suggests that nurse involvement in transportation and care can be effective in managing health conditions. ^{1 2 3 4 5}

Is nurse visitation for chronic disease safe for humans?

Research on nurse visitation programs, especially for low-income and at-risk families, shows they are generally safe and can reduce child abuse, emergency room visits, and improve health outcomes for mothers and children. ^{6 7 8 9 10}

How does nurse visitation for chronic disease differ from other treatments?

Nurse visitation for chronic disease is unique because it involves personalized home visits by nurses, focusing on education and self-care, which can improve health outcomes and reduce healthcare costs. This approach is different from traditional treatments that may not offer the same level of individualized support and direct interaction in the patient's home environment. ^{7 9 11 12 13}

What is the purpose of this trial?

This study is a longitudinal cohort study that follows participants in a randomized clinical trial of a program of prenatal and early child home visiting on maternal and offspring risks for chronic disease.

Eligibility Criteria

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

I am pregnant, less than 29 weeks along, and have never had a live birth.

Mothers who participated in a randomized clinical trial of nurse home visiting and their first-born offspring

At least two of the following sociodemographic risk conditions: unmarried, less than 12 years of education, and unemployed

Exclusion Criteria

I refused earlier data gathering assessments.

I am more than 29 weeks pregnant.

Previous live births

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

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.

Approximately 2 years

Multiple visits (in-person)

Long-term Follow-up

Participants are monitored for chronic disease and mortality outcomes approximately 30 years after delivery.

30 years

1 visit (in-person)

Treatment Details

Interventions

• Transportation and Developmental Screening
• Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy

Trial Overview The study examines the long-term effects of prenatal and early childhood home visits by nurses on reducing risks for chronic diseases in mothers and their children. Participants receive transportation support and developmental screenings.

Participant Groups

Group I: Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy Experimental Treatment 1 Intervention

Free transportation for scheduled prenatal care; intensive nurse home-visitation services during pregnancy and through the child's second birthday; and developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.

Group II: Arm 1. Transportation and Screening Active Control 1 Intervention

Free transportation for scheduled prenatal care, developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Medpace, Inc.

Industry Sponsor

Trials

98

Recruited

30,400+

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

Trials

883

Recruited

555,000+

Findings from Research

The Nurse Home Visitation Program significantly benefits low-income unmarried mothers by reducing rates of childhood injuries and neglect, helping them delay subsequent pregnancies, and improving their economic self-sufficiency, as shown in randomized trials in Elmira and Memphis.

Long-term follow-up indicates that mothers who received nurse visits were less likely to abuse their children and had children who experienced fewer arrests and substance use, highlighting the program's effectiveness in promoting healthier family dynamics and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal and infancy home visitation by nurses: recent findings. Olds, DL., Henderson, CR., Kitzman, HJ., et al.[2022]

Home-visitation programs for socially disadvantaged women and children can significantly improve maternal health behaviors, birth outcomes, and child development, while also reducing child abuse and hospital visits.

The most effective programs involved nurses who started visits during pregnancy, maintained frequent contact, and focused on addressing behavioral and psychosocial factors, particularly for families at higher risk due to poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? Olds, DL., Kitzman, H.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A prospective study of nurse-supervised versus physician-supervised neonatal transports. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Indicators of continuous improvement of the transfer of neonatal emergency cases in the Trento province]. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Perinatal morbidity and mortality for extremely low-birthweight infants: A population-based study of regionalized maternal and neonatal transport. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Parental Presence in Pediatric Interfacility Critical Care Transport: A Descriptive Study of Children, Parents, and Health Care Professionals' Opinions. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Neonatal transport in California: findings from a qualitative investigation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Prenatal and infancy home visitation by nurses: recent findings. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Preventing child abuse and neglect: a randomized trial of nurse home visitation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Quantitative and qualitative home assessment of primary caretaker-child interactions in lower socioeconomic families. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Home visits with first-time moms enhance self-care and improve birth outcomes. [2004]

10. United States pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Perinatal Nurse Home Visiting Referral Patterns Among Women With Diabetes and Hypertension in Philadelphia. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Prenatal and Infancy Nurse Home Visiting Effects on Mothers: 18-Year Follow-up of a Randomized Trial. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Is a universal nurse home visiting program possible? A cross-sectional survey of nurse home visitation service needs among pregnant women and mothers with young children. [2022]