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OpenTrials
Completed

NCT Number: NCT05934370

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

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.

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Key information

Conditions

Asthma in Children

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Asthma exacerbation requiring systemic steroids within 3 month of consent OR
  • 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

Treatment and study plan

Home-Based Environmental Interventions (HEI)

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.

Primary outcomes

  1. Patient Satisfaction

    Time frame: Week 10

    A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver

  2. Caregiver Satisfacation Survey

    Time frame: Week 10

    A measure of satisfaction by distributing a satisfaction survey to each patient and caregiver

  3. Change in Air -Quality Index

    Time frame: Week 4, Week 10

    Air-quality index assessments will include: PM2.5, PM10, total VOC's, formaldehyde, carbon dioxide, Air Quality Index) in child's room and main living room using the Temtop M10, Temptop 2000C, and HEPA purifier air quality monitor.

  4. Asthma healthcare utilization measured by number of clinic visits needed

    Time frame: Through study completion, an average of 24 weeks

    Determine ongoing need for healthcare utilization for participant's asthma

  5. Asthma healthcare utilization measured by number of Emergency Department visits

    Time frame: Through study completion, an average of 24 weeks

    Determine ongoing need for healthcare utilization for participant's asthma

  6. Asthma healthcare utilization measured by number of urgent care visits

    Time frame: Through study completion, an average of 24 weeks

    Determine ongoing need for healthcare utilization for participant's asthma

  7. Asthma healthcare utilization measured by number of hospitalizations

    Time frame: Through study completion, an average of 24 weeks

    Determine ongoing need for healthcare utilization for participant's asthma

Secondary outcomes

  1. Study Completion

    Time frame: Through study completion, an average of 24 weeks

    Study completion will be measured when 30 participants enroll and complete the intervention

  2. Change in Air Quality of Formaldehyde measured by a Temtop M10

    Time frame: Week 8

    The Temtop M10 will measure the amount of Formaldehyde in the home

  3. Change in Air Quality of Particulate Matter (PM) measured by a Temtop M10

    Time frame: Week 8

    The Temtop M10 will measure the amount of Particulate Matter (PM) 2.5 in the home

  4. Change in Air Quality of TVOC measured by a Temtop M10

    Time frame: Week 8

    The Temtop M10 will measure the amount of TVOC in the home

  5. Change in Air Quality measured by a Temtop M10

    Time frame: Week 8

    The Temtop M10 will measure the air quality in the home

  6. Air Quality changes of Particulate Matter (PM) 2.5 measured by a Temtop M2000c

    Time frame: Week 8

    The Temtop M2000c will measure the Particulate Matter (PM)2.5

  7. Air Quality changes of particles measured by a Temtop M2000c

    Time frame: Week 8

    The Temtop M2000c will measure the number of particles in the home

  8. Air Quality changes of carbon dioxide measured by a Temtop M2000c

    Time frame: Week 8

    The Temtop M2000c will measure the amount of carbon dioxide in the home

  9. Air Quality changes of particulate matter (PM 10) measured by a Temtop M2000c

    Time frame: Week 8

    The Temtop M2000c will measure the amount of particulate matter (PM 10) in the home

  10. Air Quality changes measured by patient's air purifier

    Time frame: Week 8

    The patient's air purifier will measure the air quality index in the home

  11. Measurement of lung function

    Time frame: Week 10

    Lung function will be measure by spirometry

  12. Asthma Symptoms measured by the Asthma Control Questionnaire (ACQ 6)

    Time frame: Week 10

    The Asthma Control Questionnaire (ACQ 6) is a 6 question self-report measure of asthma symptoms over the prior week. Items are rated on a sale ranging from 0 (never interferes with daily life) to 6 (interferes very severely with daily life). Higher scores indicate a worse outcome than lower scores.

  13. Asthma symptoms measured by the Asthma Control Test (ACT or cACT)

    Time frame: Week 10

    The Asthma Control Test (ACT or cACT) is a 5 question self-report measure of asthma symptoms over the prior four weeks. Items are rated on a scale ranging from 1 (All of the time) to 5 (none of the time). Lower scores indicate a worse outcome than higher scores.

  14. Asthma symptoms measured by the Duke Asthma Score (DAS)

    Time frame: Week 10

    The Duke Asthma Score (DAS) is a 6 question self-report measure of asthma symptoms over the prior month. Items are rated on a scale ranging from 0 (never) to 4 (every day). Higher scores indicate a worse outcome than lower scores.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: DRC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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