Peer Led Asthma Self Management for Adolescents: PLASMA
Condition: Asthma
MeSH terms: Asthma
Intervention: PLASMA
Intervention description: A structured asthma self-management manual ("Let's Talk about Asthma [LTAA],"developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. Group learning activities will closely align with the program manual (LTAA) that consists of three sessions. Participants will also learn and practice skills in using the peak flow meter, spacer and inhaler, daily symptom diary and asthma action plan. Besides instructional activities, participants will engage in recreational activities that each camp site.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Given the overt nature of the intervention, blinding either participants or investigators was not achieved although we did not inform participants of their group membership explicitly.
Enrollment: 371.0
Sex: All
Minimum age: 12 Years
Maximum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: asthma; adolescent; intervention

Summary:

      Asthma is a serious chronic health condition particularly in inner-city adolescents, who
      suffer disproportionately high asthma-related morbidity and mortality that place heavy
      economic burdens on families and society. There is a consensus that adverse asthma outcomes
      can be ameliorated by an individual's active engagement in adequate self-management. This
      multi-site randomized controlled study proposes to implement and evaluate a peer-led asthma
      self-management for adolescents (PLASMA) program that has demonstrated its feasibility and
      preliminary efficacy in a previous study. PLASMA will be implemented in three cities (Buffalo
      NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma and
      asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA
      comprises three main components: (a) peer-leader training; (b) a one-day asthma camp where
      peer leaders will deliver manualized self-management content recommended by the national
      guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate the
      effectiveness of PLASMA in inner-city adolescents with asthma in improving quality of life
      (primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy,
      self-management skills, and asthma control, FEV1 (exploratory outcomes) over time, compared
      to a control group for whom adult leaders will deliver the same program content; (2) to
      examine the mediating effects of the exploratory outcomes on quality of life; (3) to examine
      the moderating effects of personal factors (e.g., age, sex, family support) on the
      intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA on
      study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact of the
      intervention. These aims will be accomplished using a two-group randomized controlled trial
      with 378 adolescents (12-17 years) from the three cities (126 for each site). A total of 42
      qualified peer leaders (14 in each site) will be enrolled based on adult nomination.
      Eligibility criteria for both peer leaders and adolescent learners include: a current asthma
      diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city
      residence; and capability of verbal and written communication in English. Participants will
      provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months post-camp
      (T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear
      mixed-effects model where level 1 represents repeated measures, level 2 = subject, and level
      3 = site. To determine the economic impact of the program, investigator will measure the
      direct healthcare costs and total costs of the program, and perform net cost analyses for
      each type of costs. In addition, investigator will estimate cost-effectiveness ratios of the
      PLASMA group compared with the control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligibility criteria for adolescent (camp) participants include:

               1. age between 12-17 years;

               2. physician-diagnosed asthma that has required health service use (preventive or
                  acute) within 12 months prior to recruitment;

               3. persistent asthma determined by current use of a control medication or presenting
                  at least one of the following four symptom levels in the past 4 weeks, as defined
                  by the NAEPP guidelines91:

          -  > 2 days/week of daytime symptoms,

          -  >3-4 times of nighttime awakening,

          -  >2 days/week of SABA use, or

          -  any interference with normal activities due to asthma (4) Investigators will include
             those with chronic health conditions except for those with conditions affecting
             respiratory system, heart disease, pneumonia, etc., and those with moderate to severe
             cognitive impairments; (5) primary residence located in the participating inner cities
             based on zip codes; and (6) ability to understand spoken and written English.

        Eligibility criteria for peer leaders include:

          1. age between 16-20 years;

          2. nomination from school teachers/nurses or healthcare providers for candidates'
             exemplary asthma self-management, leadership, and emotional intelligence; and

          3. fulfillment of eligibility criteria (2)-(6) prescribed for adolescent participants.

        Exclusion Criteria:

          1. Adolescents who are pregnant or incarcerated at enrollment;

          2. Have learning disabilities based on reports from teachers or clinicians will be
             excluded from the study because such conditions can confound the interpretation of
             findings;

          3. Those who have serious health (other than asthma) and emotional preconditions (e.g.,
             severe depression, anxiety disorders, schizophrenia).