Peer Led Asthma Self Management for Adolescents: PLASMA



Status:Active, not recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 20
Updated:11/17/2018
Start Date:May 14, 2015
End Date:November 2019

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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.

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.

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).
We found this trial at
4
sites
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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920 Madison Ave
Memphis, Tennessee 38163
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Memphis, TN
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Buffalo, New York 14215
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Buffalo, NY
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