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

NCT ID: NCT05934370

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-11-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Participants

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.

Group Type OTHER

Home-Based Environmental Interventions (HEI)

Intervention Type OTHER

Housing Specialist will conduct an environmental home assessment to identify asthma triggers.

• The participant will receive the following Breath Easy at Home Kit Products:

* HEPA filtered upright vacuum cleaner
* HEPA-filtered air purifier
* Hypoallergenic latex free mattress and pillow covers
* Healthier household cleaners
* Non-toxic pest control devices for rodent control
* Safe products to locate and kill roaches.

Interventions

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Home-Based Environmental Interventions (HEI)

Housing Specialist will conduct an environmental home assessment to identify asthma triggers.

• The participant will receive the following Breath Easy at Home Kit Products:

* HEPA filtered upright vacuum cleaner
* HEPA-filtered air purifier
* Hypoallergenic latex free mattress and pillow covers
* Healthier household cleaners
* Non-toxic pest control devices for rodent control
* Safe products to locate and kill roaches.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Lang, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00113089

Identifier Type: -

Identifier Source: org_study_id