Dust Mite Allergen Reduction Study
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine whether use of an in-home test kit results in decreased dust mite
      allergen levels in homes of children who are sensitive or allergic to dust mites. Dust mite
      allergens come from dust mites - microscopic spider-like animals that feed on house dust.
      Dust mites are common anywhere there is dust, such as in carpeting and beds. Some people are
      allergic to dust mite allergens and may develop asthma from living near them.

      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: 
      Sensitization to dust mite allergens is a major risk factor for the development and
      exacerbation of asthma. Asthmatics and others with dust mite allergies often implement
      strategies to avoid dust mite exposure, but lack objective evidence that their efforts are
      successful in reducing dust mite populations. Recently developed in-home test kits have
      introduced the capability to monitor the effectiveness of allergen reduction strategies by
      providing an affordable, simple way to measure dust mite allergens on a regular basis. The
      primary objective of this study is to determine if use of an in-home test kit result in
      decreased dust mite allergen levels in homes of children sensitive or allergic to dust mites.
      A secondary objective is to determine if use of an in-home test kit result in attitudinal
      and/or behavioral changes related to implementing and maintaining dust mite reduction
      strategies.

      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.
    

Intervention name(s): MITE-T-FASTtest kit
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Asthma; Allergy; Intervention; Behaviors; Test-Kit; Dust Mites Allergen