CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 371 enrolled
Drug / intervention
PLASMAbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02293499
NCT02293499Phase 2Completed

Peer Led Asthma Self Management for Adolescents: PLASMA

University of Rochester·interventional·Posted Nov 18, 2014·Updated Apr 8, 2021

In Brief

A Phase 2 clinical trial evaluating PLASMA for Asthma. Completed, enrolled 371 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartMay 14, 2015
Primary CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.6 years ago

Interventions

PLASMAbehavioral

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.