Poor Asthma Control Clinical Trial
— DHBHHOfficial title:
Durham Healthy Breathing in Healthy Homes Project: A Duke-Reinvestment Partners Collaborative
| NCT number | NCT04119271 |
| Other study ID # | Pro00102762 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 18, 2022 |
| Est. completion date | May 11, 2023 |
| Verified date | February 2023 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | May 11, 2023 |
| Est. primary completion date | May 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 16 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University | Reinvestment Partners |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of completed home visits as measured by completion logs | 2 months | ||
| Primary | Number of completion of the post-intervention phone visit as measured by call logs | Four Months | ||
| Primary | Number of caregiver reporting satisfaction with intervention as measured by survey responses | Four Month | ||
| Secondary | 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. | 3 weeks and 7 weeks | |
| Secondary | Change in Indoor Air Quality measured by questionnaire | Sponsor developed questionnaire-15 to 20 questions asking about air quality. | 3 weeks and 7 weeks | |
| Secondary | Change in Asthma Symptoms | Change in asthma symptom control measured by the asthma control questionnaire 6 (ACQ6) (ambulatory participants only). | 1 week and 4 months | |
| Secondary | 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), | 1 week and 4 months | |
| Secondary | 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. | 1 week and 4 months | |
| Secondary | Change in Spirometry Values as measured by spirometric measures | The Spirometer measure is theforced expiratory volume in 1 second (FEV1), | 1 week and 4 months | |
| Secondary | Change in Spirometry Values as measured by spirometric measures | The Spirometeric Measure is the FEV1/FVC ratio | 1 week and 4 months | |
| Secondary | 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). | 1 week and 4 months |