AsthmaPhase 2PLASMANCT02293499
Peer Led Asthma Self Management for Adolescents: PLASMA
A Phase 2 study testing PLASMA in people with Asthma, run by University of Rochester at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- PLASMA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2015to 28 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Eligibility criteria for adolescent (camp) participants include:
- age between 12-17 years;
- physician-diagnosed asthma that has required health service use (preventive or acute) within 12 months prior to recruitment;
- 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,
Show all 12Show fewer
- >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:
- age between 16-20 years;
- nomination from school teachers/nurses or healthcare providers for candidates' exemplary asthma self-management, leadership, and emotional intelligence; and
- fulfillment of eligibility criteria (2)-(6) prescribed for adolescent participants.
Who cannot join
- Adolescents who are pregnant or incarcerated at enrollment;
- 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;
- Those who have serious health (other than asthma) and emotional preconditions (e.g., severe depression, anxiety disorders, schizophrenia).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University at Buffalo
Buffalo, New York, 14203
University of Tennessee
Memphis, Tennessee, 38163
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read the 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:
- 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.
- 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.
- To examine the moderating effects of personal factors (e.g., age, sex, family support) on primary and secondary outcomes of the intervention.
- 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.
- 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.
- Conditions
- Asthma
- Being tested
- PLASMA
- Keywords
- asthma, adolescent, intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLASMABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Led Asthma Self-Management | Active comparator | Peer-led asthma self-management for adolescents : PLASMA will be implemented in small groups at a camp setting where paired peer-leaders will facilitate learning activities.Paired peer leaders will share and coordinate the responsibilities of facilitating group activities. Training content includes: Day 1: Asthma basics and prevention; Day 2: Asthma monitoring and management; Day 3: Communication/ psychosocial issue management/leadership training/hands-on practice in simulated peer-led group settings (role-play) Receives: Behavioral: PLASMA |
| Adult Led Asthma Self-Management | Active comparator | The adult led asthma self-management will take place within 2 weeks of the peer-led camp to minimize the history effect. Two healthcare professionals will attend peer-leader training sessions to become familiar with the program content, then lead instructional activities. As in PLASMA, adult leaders will base their instruction on the program manual to ensure comparable program content. Adult leaders will adopt mainly a didactic format and skill demonstration. Receives: Behavioral: PLASMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Asthma Quality of Life Questionnaire (PAQOL)
a 23-item instrument, 118 consists of three subdomains: activity limitation (5 items), emotional function (8 items), and symptoms (10 items). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life.
Measured: 15 months
Secondary outcomes (8)
Adolescent Asthma Knowledge Questionnaire (AAK)
This 30-item instrument is a modification of the original 27-item questionnaire measuring children's knowledge of triggers and symptom identification and asthma management procedures. Total score range from 0 to 30, with higher score indicating greater knowledge.
Measured: 15 months
Attitude Toward Asthma Scale (ATA)
This 13-item scale measures children's attitudes toward their asthma on a 5-point Likert-type scale. Mean score ranges from 1 to 5, with higher score indicating a more positive attitude.
Measured: 15 months
Asthma Self-Efficacy (ASE)
This 14-item instrument measured on a 5-point scale (from 1='not at all sure' to 5='completely sure') assesses a child's confidence in attack prevention (e.g., learning asthma self-management skills, correct use of medication) and attack management (e.g., control symptoms, decide which medication to use). A total score was computed, ranging from 14 and 70, with higher values indicating greater self-efficacy.
Measured: 15 months
Asthma Outcome Expectation Scale (AOE)
This 5 items scale measured on a 9-point scale from 'not all all (1)' to 'extremely (9)' assess the construct of "outcome expectations" derived from social cognitive theory. The average score was computed, ranging from 1 to 9, with higher scores suggesting more positive expectations about performing actions of asthma self-management.
Measured: 15 months
Asthma Prevention Index
This is one of 3 subscales of asthma self-management indices developed for adolescents with asthma. The prevention index consists of 11 items measured on a 3-point scale. An average score based on items 1-9 was computed, ranging from 1 to 3, with higher scores suggesting greater regularity of prevention steps.
Measured: 15 months
Asthma Management Index (AMI)
This is one of the 3 subscales of Asthma Self-Management Indices. This subscale (9 items total) measures the number of steps taken to manage symptoms once they occur, and two response options are given, 0=no and 1=yes. Items 1-4, 6, 8 \& 9 were summed for a total count of management steps taken, with possible scores ranging from 0 to 7. The higher the sum scores, the greater the number of steps taken to manage symptoms.
Measured: 15 months
Asthma Management Self-efficacy Index
This is one of 3 subscales of asthma self-management indices developed for adolescents with asthma. The self-efficacy index consists of 14 items measured on a 6-point scale (1='I am very sure I could not'; 6='I am very sure I could'). An average score of all 14 items was computed, ranging from 1 to 6, with higher scores suggesting greater self-efficacy.
Measured: 15 months
Asthma Control Questionnaire (ACQ)
ACQ consists of 6-items measuring asthma control based on the frequency, severity, and types of symptoms, as well as degree of activity limitation, and use of SABA in the past 7 days. Each item was responded on a 6-point scale from 0 to 6. Average scores were computed, with higher scores indicating worse asthma control.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study start14 May 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Tennessee
- Responsible party
- Principal investigator, Hyekyun Rhee, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293499
- Sponsor's protocol ID
- RSRB00053987
- Acronym
- PLASMA
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2014
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rhee H, Love T, Wicks MN, Tumiel-Berhalter L, Sloand E, Harrington D, Walters L. Long-term Effectiveness of a Peer-Led Asthma Self-management Program on Asthma Outcomes in Adolescents Living in Urban Areas: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2137492. doi: 10.1001/jamanetworkopen.2021.37492.
PubMed 34874404Rhee H, Love T, Mammen J. Comparing Asthma Control Questionnaire (ACQ) and National Asthma Education and Prevention Program (NAEPP) asthma control criteria. Ann Allergy Asthma Immunol. 2019 Jan;122(1):58-64. doi: 10.1016/j.anai.2018.09.448. Epub 2018 Sep 11.
PubMed 30213611Rhee H, Love TM, Harrington D, Grape A. Comorbidity of atopy in urban adolescents with asthma. Ann Allergy Asthma Immunol. 2017 Nov;119(5):466-467. doi: 10.1016/j.anai.2017.08.017. No abstract available.
PubMed 29150074
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Led Asthma Self Management for Adolescents: PLASMA
- ClinicalTrials.gov ID
- NCT02293499
- Acronym / sponsor ID
- PLASMA / RSRB00053987
- Conditions
- Asthma
- Keywords
- asthma, adolescent, intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Tennessee
- Study start
- 14 May 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To examine the moderating effects of personal factors (e.g., age, sex, family support) on primary and secondary outcomes of the intervention.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Led Asthma Self-Management | Active comparator | Behavioral: PLASMAPeer-led asthma self-management for adolescents : PLASMA will be implemented in small groups at a camp setting where paired peer-leaders will facilitate learning activities.Paired peer leaders will share and coordinate the responsibilities of facilitating group activities. Training content includes: Day 1: Asthma basics and prevention; Day 2: Asthma monitoring and management; Day 3: Communication/ psychosocial issue management/leadership training/hands-on practice in simulated peer-led group settings (role-play) |
| Adult Led Asthma Self-Management | Active comparator | Behavioral: PLASMAThe adult led asthma self-management will take place within 2 weeks of the peer-led camp to minimize the history effect. Two healthcare professionals will attend peer-leader training sessions to become familiar with the program content, then lead instructional activities. As in PLASMA, adult leaders will base their instruction on the program manual to ensure comparable program content. Adult leaders will adopt mainly a didactic format and skill demonstration. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Eligibility criteria for adolescent (camp) participants include:
- > 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.
Key exclusion criteria (3 listed)
- Adolescents who are pregnant or incarcerated at enrollment;
- 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;
- Those who have serious health (other than asthma) and emotional preconditions (e.g., severe depression, anxiety disorders, schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLASMAA 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. | Behavioural | Adult Led Asthma Self-Management, Peer Led Asthma Self-Management |
Primary outcome
The Pediatric Asthma Quality of Life Questionnaire (PAQOL)
Time frame: 15 months
a 23-item instrument, 118 consists of three subdomains: activity limitation (5 items), emotional function (8 items), and symptoms (10 items). Higher scores indicate better levels of functioning. This scale has proved a valid and reliable measure of asthma-specific quality of life in adolescents. Mean scores are reported, and range from 1 to 7. Higher score indicating higher quality of life.
8 secondary outcomes
Adolescent Asthma Knowledge Questionnaire (AAK)
Time frame: 15 months
Attitude Toward Asthma Scale (ATA)
Time frame: 15 months
Asthma Self-Efficacy (ASE)
Time frame: 15 months
Asthma Outcome Expectation Scale (AOE)
Time frame: 15 months
Asthma Prevention Index
Time frame: 15 months
Asthma Management Index (AMI)
Time frame: 15 months
Asthma Management Self-efficacy Index
Time frame: 15 months
Asthma Control Questionnaire (ACQ)
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34874404Rhee H, Love T, Wicks MN, Tumiel-Berhalter L, Sloand E, Harrington D, Walters L. Long-term Effectiveness of a Peer-Led Asthma Self-management Program on Asthma Outcomes in Adolescents Living in Urban Areas: A Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2137492. doi: 10.1001/jamanetworkopen.2021.37492.
- Derived from this study: PubMed 30213611Rhee H, Love T, Mammen J. Comparing Asthma Control Questionnaire (ACQ) and National Asthma Education and Prevention Program (NAEPP) asthma control criteria. Ann Allergy Asthma Immunol. 2019 Jan;122(1):58-64. doi: 10.1016/j.anai.2018.09.448. Epub 2018 Sep 11.
- Derived from this study: PubMed 29150074Rhee H, Love TM, Harrington D, Grape A. Comorbidity of atopy in urban adolescents with asthma. Ann Allergy Asthma Immunol. 2017 Nov;119(5):466-467. doi: 10.1016/j.anai.2017.08.017. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLASMA in people with Asthma, run by University of Rochester at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Asthma Quality of Life Questionnaire (PAQOL) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02293499, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.