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Durham Healthy Breathing in Healthy Homes Project (DHBHH)

Primary Purpose

Poor Asthma Control

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathe Easy at Home Kit Products
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poor Asthma Control

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parent/legal guardian has provided informed consent (child has provided assent if needed)
  • 5-16 years of age with physician-diagnosed asthma
  • Evidence of poor asthma control defined as either:

Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 > 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks

Exclusion Criteria:

  • Lack of informed consent
  • Any major chronic illness that in the opinion of the 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
  • Family is planning to move households in the next 2 months
  • Parent/Caregiver unable to consent in English
  • Sensitivity or allergy to silicone

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Breathe Easy at Home Kit Products

Arm Description

Families will be provided with a Breathe Easy at Home Kit. These kits will include: a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches.

Outcomes

Primary Outcome Measures

Number of completed home visits as measured by completion logs
Number of completion of the post-intervention phone visit as measured by call logs
Number of caregiver reporting satisfaction with intervention as measured by survey responses

Secondary Outcome Measures

Change in Environmental Wristband Markers
changes in targeted environmental wristband markers of exposure to organic contaminants in the home environment, including phthalates, organophosphate esters, several pesticides, and polyaromatic hydrocarbon (PAH) markers evaluated using personal silicone wristband monitors. Paired t-tests (or Wilcoxon signed rank tests for non-parametric data) will be used to assess post-intervention changes in targeted wristbands toxin levels.The relationship between changes in these outcomes and measures of intervention adherence will be analyzed using Pearson correlations and ANOVA trend testing as appropriate.
Change in Indoor Air Quality measured by questionnaire
Sponsor developed questionnaire-15 to 20 questions asking about air quality.
Change in Asthma Symptoms
Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only).
Change in Spirometry Values as measured by spirometric measures
Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. Spirometric measures is the forced vital capacity (FVC),
Change in Asthma Symptoms
Improvements in asthma control following HEI measured using asthma control scores and lung function. For patients enrolled in the ambulatory setting, change in FEV1, FEV1/FVC by spirometry will be calculated.
Change in Spirometry Values as measured by spirometric measures
The Spirometer measure is theforced expiratory volume in 1 second (FEV1),
Change in Spirometry Values as measured by spirometric measures
The Spirometeric Measure is the FEV1/FVC ratio
Change in Spirometry Values as measured by spirometric measures
The Spirometric Measure is the forced expiratory flow average over 25-75% of FVC (FEF25-75).

Full Information

First Posted
October 3, 2019
Last Updated
February 14, 2023
Sponsor
Duke University
Collaborators
Reinvestment Partners
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1. Study Identification

Unique Protocol Identification Number
NCT04119271
Brief Title
Durham Healthy Breathing in Healthy Homes Project
Acronym
DHBHH
Official Title
Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
December 2, 2024 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Reinvestment Partners

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine if Home-based Environmental Interventions (HEI) that improve home air-quality problems can improve asthma outcomes. Participants will benefit through home-based environmental interventions that improve home air-quality problems and improve asthma outcomes. All participants will receive a Breath Easy at Home Kit, which could help with reducing environmental exposures. The primary objective is to assess the feasibility and acceptability of the HEI measured by the proportion of families completing intervention components and proportion of caregivers expressing satisfaction with intervention components. Secondary objective is to explore the efficacy of a HEI on reducing environmental exposures measured using personal wristband monitors. Exploratory objective is improvements in asthma control following HEI measured using asthma control scores and lung function. The fourth objection is to explore correlations between demographics, body weight, housing characteristics (smokers, electronic cigarette use, number of pets, housing type) with measures of acceptability, satisfaction and improved exposure markers.
Detailed Description
The investigator propses a 23-week prospective, open label, single center, environmental remediation intervention study in 5-16 year old children with poor asthma control. At visit 1, wristbands will be dispensed and collected to estimate exposure to a suite of common organic contaminants including phthalates, organophosphate esters, several pesticides and polyaromatic hydrocarbons (PAH). During the initial home visit, the Healthy Homes Housing Specialist will conduct an environmental home assessment to identify asthma triggers in accordance with the EPA's recommendations for helping children with asthma. The Housing Specialist will follow the EPA document Home Characteristics and Asthma Triggers, and will provide the family with a Breathe Easy at Home Kit. The Specialist will provide training and instructions on how to use each of the supplies provided in the kit. If the Housing Specialist identifies necessary home repairs during the assessment process, the Housing Specialist can refer the family to organizations that offer home repairs, modifications, and weatherization services. The specialist will discuss the importance of clean air for maintaining lung health for all family members and will discuss the importance of banning of any indoor smoking, smoking anywhere around the household and smoking in any household automobiles (even when the child is not present). Follow up phone calls will be conducted to answer questions, complete questionnaires and complete a household environmental interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poor Asthma Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breathe Easy at Home Kit Products
Arm Type
Other
Arm Description
Families will be provided with a Breathe Easy at Home Kit. These kits will include: a HEPA filtered upright vacuum cleaner, a HEPA-filtered Air Purifier, a Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control, and a combination of safe products to locate and kill roaches.
Intervention Type
Other
Intervention Name(s)
Breathe Easy at Home Kit Products
Intervention Description
HEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches.
Primary Outcome Measure Information:
Title
Number of completed home visits as measured by completion logs
Time Frame
2 months
Title
Number of completion of the post-intervention phone visit as measured by call logs
Time Frame
Four Months
Title
Number of caregiver reporting satisfaction with intervention as measured by survey responses
Time Frame
Four Month
Secondary Outcome Measure Information:
Title
Change in Environmental Wristband Markers
Description
changes in targeted environmental wristband markers of exposure to organic contaminants in the home environment, including phthalates, organophosphate esters, several pesticides, and polyaromatic hydrocarbon (PAH) markers evaluated using personal silicone wristband monitors. Paired t-tests (or Wilcoxon signed rank tests for non-parametric data) will be used to assess post-intervention changes in targeted wristbands toxin levels.The relationship between changes in these outcomes and measures of intervention adherence will be analyzed using Pearson correlations and ANOVA trend testing as appropriate.
Time Frame
3 weeks and 7 weeks
Title
Change in Indoor Air Quality measured by questionnaire
Description
Sponsor developed questionnaire-15 to 20 questions asking about air quality.
Time Frame
3 weeks and 7 weeks
Title
Change in Asthma Symptoms
Description
Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only).
Time Frame
1 week and 4 months
Title
Change in Spirometry Values as measured by spirometric measures
Description
Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds. During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system. Spirometric measures is the forced vital capacity (FVC),
Time Frame
1 week and 4 months
Title
Change in Asthma Symptoms
Description
Improvements in asthma control following HEI measured using asthma control scores and lung function. For patients enrolled in the ambulatory setting, change in FEV1, FEV1/FVC by spirometry will be calculated.
Time Frame
1 week and 4 months
Title
Change in Spirometry Values as measured by spirometric measures
Description
The Spirometer measure is theforced expiratory volume in 1 second (FEV1),
Time Frame
1 week and 4 months
Title
Change in Spirometry Values as measured by spirometric measures
Description
The Spirometeric Measure is the FEV1/FVC ratio
Time Frame
1 week and 4 months
Title
Change in Spirometry Values as measured by spirometric measures
Description
The Spirometric Measure is the forced expiratory flow average over 25-75% of FVC (FEF25-75).
Time Frame
1 week and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent/legal guardian has provided informed consent (child has provided assent if needed) 5-16 years of age with physician-diagnosed asthma Evidence of poor asthma control defined as either: Hospitalization at Duke Children's Hospital within past 30 days or, ACQ6 > 1.0 during ambulatory visit to Duke Asthma Center within 2 weeks Exclusion Criteria: Lack of informed consent Any major chronic illness that in the opinion of the 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 Family is planning to move households in the next 2 months Parent/Caregiver unable to consent in English Sensitivity or allergy to silicone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nedenia C Parker, BS
Phone
919-684-6127
Email
nedenia.parker@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason E Lang, MD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Wilson, BSN
Phone
919-681-8739
Email
joan.wilson@duke.edu
First Name & Middle Initial & Last Name & Degree
Jason E Lang, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Durham Healthy Breathing in Healthy Homes Project

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