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The Duke-Reinvestment Partners Community Collaborative (DRC)- Healthy Homes

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Duke University

Status

Completed

Conditions

Asthma in Children

Treatments

Other: Home-Based Environmental Interventions (HEI)

Study type

Interventional

Funder types

Other

Identifiers

NCT05934370
Pro00113089

Details and patient eligibility

About

The goal of this open-label, single arm home intervention feasibility study is to improve quality of life for children ages 4-16 years with asthma.

The main questions it aims to answer are:

  • How can Home-Based Environmental Interventions (HEI) improve home air-quality problems in the home?
  • How can HEI improve asthma outcomes in children?

Participants will be receiving HEI and completing asthma surveys.

Full description

All participants will receive an Intervention Kit, which could help with reducing environmental exposures. Participants will be monitored closely with up to 2 clinic visits, 2 home visits and up to 4 phone call visits. During the home visits, a study team will ask questions about your home and asthma, conduct home assessments, and provide training on use of the home kit.

Participants may benefit from participation in this study through Home-Based Environmental Interventions by improving home air-quality and asthma outcomes. Study duration is approximately 24-30 weeks with 8 weeks of intervention, which includes baseline interview, questionnaires, spirometry testing, and participants receiving an Intervention Kit.

Enrollment

36 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Parent/legal guardian has provided informed consent (child has provided assent if needed)

  • 4-16 years of age with medical provider -diagnosed asthma

  • Evidence of recent poor asthma control, defined as either:

    1. Asthma exacerbation requiring systemic steroids within 3 month of consent OR
    2. ACQ6 > 1.0; or ACT/cACT ≤ 19 during ambulatory visit within 3 months of consent
  • Family lives in one of the following Central NC counties: Alamance, Chatham, Durham, Franklin, Granville, Johnston, Lee, Orange, Person, Vance, or Wake counties

  • Family is not planning to move out of one of the approved counties accessible to Reinvestment Partners in the next 6 months

Exclusion criteria

  • Lack of informed consent
  • Any major chronic illness that in the opinion of the Principal Investigator (PI) would interfere with participation in the intervention or completion of the study procedures
  • Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or PI
  • Parent/Caregiver unable to consent in English or Spanish
  • Sensitivity or allergy to silicone

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Study Participants
Other group
Description:
Participants will receive an intervention kit that will include two at-home visits and the following products: child bedroom HEPA-air purifier, HEPA upright vacuum, hypoallergenic dust-mite cover for child's mattress and pillow covers; Non-toxic household cleaning products and non-toxic pest/rodent traps.
Treatment:
Other: Home-Based Environmental Interventions (HEI)

Trial contacts and locations

1

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Central trial contact

Erin Frost, BS

Data sourced from clinicaltrials.gov

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