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Clinical Trials/NCT06474767
NCT06474767
Not yet recruiting
Not Applicable

Addressing Health Disparities in Chronic Lung Disease for Preterm Infants Through Parent Engagement

Johns Hopkins University0 sites50 target enrollmentJuly 1, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Lung Disease
Sponsor
Johns Hopkins University
Enrollment
50
Primary Endpoint
Feasibility as measured by number of interventions completed
Status
Not yet recruiting
Last Updated
7 months ago

Overview

Brief Summary

The goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of Black preterm infants with chronic lung disease in primary care. Preliminary impact on child and parent outcomes will also be explored.

The main questions it aims to answer are: 1) Will parents complete a pre-visit questionnaire that asks about goals for the child? 2) Does use of the pre-visit questionnaire help parents to achieve self-identified goals?

Participants will fill out a pre-visit questionnaire prior to the child's well visit. The participants will then complete two surveys after the visit (1 week and 2 months after).

Registry
clinicaltrials.gov
Start Date
July 1, 2026
End Date
June 30, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Parent/legal guardian of child born prior to 37 weeks gestational age
  • Parent/legal guardian of child with diagnosis of chronic lung disease or bronchopulmonary dysplasia, as defined by the child's clinical team at the time of hospital discharge
  • Parent/legal guardian of child who identifies that child's race as Black
  • English speaking

Exclusion Criteria

  • Parent/legal guardian of child enrolled in palliative care or hospice services at time of hospital discharge
  • Parent/legal guardian of child older than 12 months chronological age

Outcomes

Primary Outcomes

Feasibility as measured by number of interventions completed

Time Frame: Day 0

Number of participants who complete the pediatric collaborative goal setting intervention out of the number of consented participants who are sent a link prior to the child's well visit

Acceptability of the intervention as assessed by the Acceptability of Intervention Measure (AIM) scale

Time Frame: Day 7 post-intervention

Measured by the Acceptability of Intervention Measure (AIM) scale - a 4 item survey with 5 point Likert scales from Completely Disagree to Completely Agree. Score ranges from 4 to 20, where higher scores indicate greater acceptability.

Feasibility as measured by the number of goals submitted by each participant

Time Frame: Day 0

Number of goals submitted by each participant through the pediatric collaborative goal setting intervention

Feasibility as measured by the time it takes participant to complete intervention

Time Frame: Day 0

Amount of time (minutes) that participant has the pediatric collaborative goal setting intervention open

Secondary Outcomes

  • Goal attainment as assessed by number of goals submitted(Day 60 post-intervention)
  • Participant's child's respiratory symptoms as measured by self-report(Day 60 post-intervention)
  • Participant's child's use of the emergency department for breathing symptoms as measured by self-report(Day 60 post-intervention)
  • Participation activation as measured by Parent Patient Activation Measure 10(Day 60 post-intervention)

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