Peer Led Asthma Self Management for Adolescents: PLASMA
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Asthma, the most common pediatric chronic condition, is a serious problem for many
      adolescents. In 2010, nearly 11% of adolescents (2.7 million) ages 12 through 17 years in the
      US reported current asthma. This age cohort suffers greater asthma-related morbidity and
      mortality than younger children. Asthma disproportionately affects inner-city youth, where
      asthma severity has increased and achieving optimum asthma control has been elusive. Several
      factors including poor socioeconomic conditions, life stresses, and environmental triggers
      have been found to be associated with poorly controlled asthma in inner-city children.
      Programs targeting asthma in inner-city children have primarily focused on the modification
      of environmental factors and addressing disparity in healthcare access. Limited intervention
      efforts have been directed to address high inner-city asthma morbidity specifically in
      adolescents by promoting adequate self-management.

      Dr. Rhee successfully completed an R21 (NR009837) where she designed an evidence-based
      peer-led asthma self-management for adolescents (PLASMA) program and tested its efficacy in a
      randomized parallel group design in 112 urban and suburban adolescents with persistent
      asthma. The PLASMA program was implemented at a one-day camp and involved monthly follow-ups
      by peer leaders. The program was well received by participants, and relative to adolescents
      who received an adult-led program, the PLASMA group reported better quality of life and
      asthma control and fewer asthma-related urgent office visits. Subgroup analysis revealed that
      the program was particularly effective for inner-city adolescents in improving asthma
      outcomes compared with suburban participants. Given the disproportionate burdens of asthma in
      inner-city youth and the program's compelling effects in this population, focusing on
      inner-city adolescents as a target of the PLASMA program is critical.

      Building on this previous trial of efficacy, the overall goal of the proposed study is to
      evaluate the effectiveness and generalizability of the peer-led intervention, PLASMA, in
      improving asthma outcomes in inner-city adolescents from three metropolitan cities in the
      Northern, Eastern and Southern US with distinctive historical and cultural backgrounds.
      Multisite studies have been advocated as an effective approach to strengthening external
      validity as such studies afford the opportunity to assess the extent to which treatment
      effects are generalizable to different settings. Ascertaining generalizability across sites
      is important as it guides future translation of study findings into policy and practice. This
      study will also determine long-term sustainability of PLASMA effects and estimate the
      economic impact of the intervention. This multi-site study is significant in that it will
      target the understudied population, inner-city adolescents with asthma in three cities in the
      US, who present serious challenges to optimum asthma management.

      Specific study aims are:

        1. To evaluate systematically the effectiveness of a peer-led asthma program in inner-city
           adolescents with persistent asthma. This aim will be accomplished by using a two-group
           randomized controlled trial with 378 adolescents (12-17 years) from the three cities.
           The intervention group will receive PLASMA involving peer leader training, a one-day
           intense asthma self-management program led by peer leaders and bimonthly contacts from
           peer leaders. Intervention effects will be examined in comparison to the control group,
           who will receive the same program content delivered by adult leaders. Investigators
           hypothesize that: relative to the control group, the PLASMA group will report greater
           improvement over time in (H1) quality of life (primary outcome), and (H2) asthma
           knowledge, attitudes, outcome expectations, self-efficacy, self-management skills, and
           asthma control, FEV1 (exploratory outcomes). (H3) The post-PLASMA scores on outcome
           measures will be higher than pre-program scores from both treatment groups.

        2. To examine the mediating effects of the secondary outcomes (knowledge, attitudes,
           outcome expectations, self-efficacy, self-management skills, asthma control, and FEV1)
           on the primary outcome (quality of life) of the intervention.

        3. To examine the moderating effects of personal factors (e.g., age, sex, family support)
           on primary and secondary outcomes of the intervention.

        4. To evaluate the effects of PLASMA on primary and exploratory outcomes in peer leaders
           (16-20 years). Investigators hypothesize that the peer leaders (n=42) will report
           significant improvement in quality of life (primary outcome) and secondary outcomes
           (knowledge, attitudes, outcome expectations, self-efficacy, self-management skills,
           asthma control and FEV1) over the course of 15 months.

        5. To determine the economic impact of the intervention. This aim will be accomplished by
           (5a) measuring the direct healthcare costs and total costs of the PLASMA program, as
           compared with the control group; (5b) performing net cost analyses for each type of
           costs; and (5c) estimating cost-effectiveness ratios of the PLASMA group compared with
           the control. Investigators hypothesize that the direct and overall costs per participant
           in the PLASMA group will be less than costs per participant in the control group, or
           cost neutral.
    

Intervention name(s): PLASMA
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; adolescent; intervention