Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269282
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2005-12-21
Brief Title:
Increasing Adherence to Asthma Medication in Urban Teens
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Motivating Asthma Adherence in Urban Teens
Status:
COMPLETED
Status Verified Date:
2013-01
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:
None
Brief Summary:
The purpose of this study is to determine the effectiveness of two home-based asthma interventions in increasing adherence to daily asthma controller medication
Detailed Description:
BACKGROUND
Low-income minority teenagers have disproportionately high rates of asthma morbidity including excess risk of emergency department ED care hospitalization and death from asthma compared to white adolescents Research by this group and others has documented that non-adherence with asthma treatment regimens is common among high-risk inner city families with asthma and that this poor adherence with prescribed therapies plays a significant contributing role in asthma morbidity Inner-city adolescents with asthma are at particular risk of non-adherence yet this population remains understudied While asthma self-management training has shown promise in achieving some improvement in adherence with asthma there are few intervention studies explicitly targeting adolescents particularly those in the inner-city Urban children typically assume primary control over their asthma management during late childhoodearly adolescence At the same time adolescents efforts to achieve autonomy and peer-acceptance may result in increased health risk behaviors including poor asthma self-management Developmentally-appropriate asthma self-management interventions are needed that target the unique challenges of adolescence Motivational Interviewing MI is a promising interventional approach that uses a client-centered non-directive approach for enhancing motivation to change health behaviors MI techniques are developmentally consistent with the needs of early adolescents MI does not assume that health will be the most important factor motivating the teen but rather acknowledges and incorporates other motivators that are within the context of the teens life thus this intervention strategy has the flexibility to adapt to the unique life circumstances and stressors faced by urban adolescents We propose to evaluate the relative effectiveness of a MI-focused self-management intervention MISM compared to a self-management SM intervention containing asthma education and self-monitoring strategies in a sample of 226 children age 10-15 years treated for asthma in the ED Our primary hypothesis is that the MISM as compared to SM alone will result in greater improvement in medication adherence at 3- and 6-months post-randomization as measured by electronic medication monitoring Secondary outcomes include self-reported medication adherence symptoms free days urgent health care utilization for asthma and caregiveradolescent quality of life
DESIGN NARRATIVE
Participants will be randomly assigned to 1 Self-Management SM Standard Care Group or 2 Motivational Interviewing plus Self-Management Training MISM Intervention Group The duration of the intervention condition will be 5 home visits over 2 months Follow-up measures will be collected from families at 3- and 6-months post-randomization
Low-income minority teenagers have disproportionately high rates of asthma morbidity including excess risk of emergency department ED care hospitalization and death from asthma compared to white adolescents Research by this group and others has documented that non-adherence with asthma treatment regimens is common among high-risk inner city families with asthma and that this poor adherence with prescribed therapies plays a significant contributing role in asthma morbidity Inner-city adolescents with asthma are at particular risk of non-adherence yet this population remains understudied While asthma self-management training has shown promise in achieving some improvement in adherence with asthma there are few intervention studies explicitly targeting adolescents particularly those in the inner-city Urban children typically assume primary control over their asthma management during late childhoodearly adolescence At the same time adolescents efforts to achieve autonomy and peer-acceptance may result in increased health risk behaviors including poor asthma self-management Developmentally-appropriate asthma self-management interventions are needed that target the unique challenges of adolescence Motivational Interviewing MI is a promising interventional approach that uses a client-centered non-directive approach for enhancing motivation to change health behaviors MI techniques are developmentally consistent with the needs of early adolescents MI does not assume that health will be the most important factor motivating the teen but rather acknowledges and incorporates other motivators that are within the context of the teens life thus this intervention strategy has the flexibility to adapt to the unique life circumstances and stressors faced by urban adolescents We propose to evaluate the relative effectiveness of a MI-focused self-management intervention MISM compared to a self-management SM intervention containing asthma education and self-monitoring strategies in a sample of 226 children age 10-15 years treated for asthma in the ED Our primary hypothesis is that the MISM as compared to SM alone will result in greater improvement in medication adherence at 3- and 6-months post-randomization as measured by electronic medication monitoring Secondary outcomes include self-reported medication adherence symptoms free days urgent health care utilization for asthma and caregiveradolescent quality of life
DESIGN NARRATIVE
Participants will be randomly assigned to 1 Self-Management SM Standard Care Group or 2 Motivational Interviewing plus Self-Management Training MISM Intervention Group The duration of the intervention condition will be 5 home visits over 2 months Follow-up measures will be collected from families at 3- and 6-months post-randomization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL079301 | NIH | None | httpsreporternihgovquickSearchR01HL079301 |