Study Results
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2005-06-06
2009-02-11
Brief Summary
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People who live in the Research Triangle Park area of North Carolina who have a child between 5 and 15 years old with a dust mite allergy or sensitivity may be eligible for this study. Participants must plan to remain in the same house for at least 12 months from the start of the study. At least half the floor of the child's room must be carpeted.
Participants are given materials on how to reduce dust mite allergens in their home. Study staff visit participants' homes three times over a 12-month period to ask questions about the home, home cleaning habits, and participants' experiences with home test kits (see below) for measuring dust mite allergen. At each visit, staff collect dust samples from the child's bedroom, the parents' bedroom, and the living room. The dust samples are analyzed in the laboratory for dust mite allergens and the results are given to the participants at the end of the study.
Participants are also given four home test kits for measuring dust mite allergen in the home. At the first home visit, staff instruct the participants on how to use the kits and answer any questions they may have. The kits are mailed at certain times during the study for the participants to use to measure allergen and send the results to the study investigators in a pre-paid addressed envelope.
A control group is given educational materials but no test kits.
Detailed Description
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This study is a randomized controlled intervention trial designed to test the efficacy of an in-home test kit in influencing behaviors to reduce dust mite allergen levels. Households will be recruited through flyers and screened for eligibility through a recruitment call line. Study participants will be randomly assigned to a treatment or control group. The treatment group will receive educational materials and an in-home test kit at set intervals, while the control group will receive educational materials alone.
Vacuumed dust samples will be collected and delivered to the NIEHS laboratory for ELISA-based measurements of the dust mite allergens Der f 2 and Der p 2. A questionnaire will be used to collect information on home characteristics and on dust mite reduction attitudes and behaviors. The Precaution Adoption Process Model (PAPM) will be used to assess changes in attitudes and behaviors. Data will be collected at baseline, 6-months, and 12-months.
The primary statistical analysis will measure the change in allergen concentrations from baseline to month 12. This change will be compared between the two study arms using a generalized linear model to test the null hypothesis of no difference between groups. In secondary analyses, data from each sampling location will be analyzed separately and changes from 0-to-6 and 6-to-12 months will be compared between the treatment and control groups. Data from the questionnaire and baseline home visits will be analyzed for each group to determine PAPM stages and transitions. The results from this study will be used by NIEHS to plan future primary and secondary asthma prevention trials.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Test Kit Homes
Households assigned to use the in-home test kit.
MITE-T-FASTtest kit
The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.
Interventions
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MITE-T-FASTtest kit
The primary objective of this randomized intervention trial is to determine if the use of an inhome test kit, as an adjunct to education, results in greater reductions in dust mite allergen levels than the use of educational materials alone.
Eligibility Criteria
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Inclusion Criteria
Plan to remain in the same house for at least 12 months.
Child in household aged 5 to 15 with allergy or sensitivity to dust mites (self-reported by parent or guardian, and a doctor's diagnosis of dust mite allergy or sensitivity is not required, i.e., if the parent or guardian believes or suspects that the child is allergic or sensitive to dust mites, that is sufficient).
Child sleeps in own bed at least 3 nights a week.
Child's room has carpeting on at least 50% of the floor.
Parents do not currently have dust mite protective mattress covers on the bed.
At least one of the two bedroom surfaces must have Group 2 dust mite allergen levels of greater than or equal to 2 microliter/g with the ELISA test AND greater than or equal to 2 microliter/g on at least one of the two Mite-T-Fast tests for inclusion.
5 Years
15 Years
ALL
No
Sponsors
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National Institute of Environmental Health Sciences (NIEHS)
NIH
Principal Investigators
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Darryl C Zeldin, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)
Locations
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Constella Group, Inc.
Durham, North Carolina, United States
Countries
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References
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Weiss KB, Sullivan SD. The health economics of asthma and rhinitis. I. Assessing the economic impact. J Allergy Clin Immunol. 2001 Jan;107(1):3-8. doi: 10.1067/mai.2001.112262.
Gergen PJ, Turkeltaub PC. The association of individual allergen reactivity with respiratory disease in a national sample: data from the second National Health and Nutrition Examination Survey, 1976-80 (NHANES II). J Allergy Clin Immunol. 1992 Oct;90(4 Pt 1):579-88. doi: 10.1016/0091-6749(92)90130-t.
Platts-Mills TA, Vervloet D, Thomas WR, Aalberse RC, Chapman MD. Indoor allergens and asthma: report of the Third International Workshop. J Allergy Clin Immunol. 1997 Dec;100(6 Pt 1):S2-24. doi: 10.1016/s0091-6749(97)70292-6. No abstract available.
Winn AK, Salo PM, Klein C, Sever ML, Harris SF, Johndrow D, Crockett PW, Cohn RD, Zeldin DC. Efficacy of an in-home test kit in reducing dust mite allergen levels: results of a randomized controlled pilot study. J Asthma. 2016;53(2):133-8. doi: 10.3109/02770903.2015.1072721. Epub 2015 Aug 24.
Other Identifiers
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05-E-N166
Identifier Type: -
Identifier Source: secondary_id
999905166
Identifier Type: -
Identifier Source: org_study_id