Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02293499
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2014-10-24
Brief Title:
Peer Led Asthma Self Management for Adolescents PLASMA
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Peer Led Asthma Self Management for Adolescents PLASMA
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLASMA
Brief 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 individuals 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 eg age sex family support on the interventions 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 27 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 programs 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 eg 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 n42 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
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 programs 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 eg 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 n42 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None