Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-31 @ 3:07 AM
Study NCT ID:
NCT00149461
Status:
COMPLETED
Last Update Posted:
2014-01-17
First Post:
2005-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Written Asthma Actions Plans Versus No Written Instructions In Specialty Care
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
The Efficacy of Written Treatment Plans in Asthma
Status:
COMPLETED
Status Verified Date:
2014-01
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 overall goal of this randomized, controlled study is to compare a model written treatment plan with the usual care that is provided by a group of adult and pediatric pulmonologists and allergists in their practice settings. The written treatment plan is a form that allows a treatment regimen that is consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines to be conveyed to patients. Barriers to the use of written plans will be identified to better understand why some patients and physicians use written treatment plans more frequently and effectively than others. An additional goal is to assess how patients from different racial/ethnic backgrounds utilize treatments plans. Because asthma disproportionately affects African American and Latino patients, another goal of this study is to better understand if there are fundamental differences in the way patients from racial/ethnic minority groups self-manage asthma in comparison to their white counterparts. The study will also try to determine if differences exist in the way physicians care for minority patients. If there are differences, it is important to determine if the disparities can be overcome with the use of a written treatment plan form.
Detailed Description:
BACKGROUND:
Effective self-management of asthma requires that patients, or their caregivers, recognize the early symptoms of an exacerbation and initiate appropriate interventions aimed at preventing the progression of symptoms. Most asthma clinical guidelines suggest that the incorporation of a written self-management plan is essential. Patients must possess, understand, and follow a written plan if they are to respond appropriately to changes in asthma status. Nevertheless, there are no controlled studies examining the efficacy of the written plan itself. Furthermore, even if written plans are an essential and effective component of successful self-management, the data suggest that few patients receive these plans. If patients and physicians are to increase their use of written plans, the barriers to the use of these plans need further investigation.
DESIGN NARRATIVE:
The three primary outcome measures of this study are as follows: 1) reduction in asthma symptom frequency; 2) reduction in urgent, unscheduled, and emergency visits for asthma; and 3) improved quality of life. These outcomes will be measured over a 12-month period.
The following four secondary outcome measures will also be examined: 1) hospitalizations due to asthma; 2) days with activity restriction; 3) the proportion of patients in the intervention group who are given the model written plan form during the initial visit; and 4) the proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period. These outcomes will be measured over a 12-month period.
Effective self-management of asthma requires that patients, or their caregivers, recognize the early symptoms of an exacerbation and initiate appropriate interventions aimed at preventing the progression of symptoms. Most asthma clinical guidelines suggest that the incorporation of a written self-management plan is essential. Patients must possess, understand, and follow a written plan if they are to respond appropriately to changes in asthma status. Nevertheless, there are no controlled studies examining the efficacy of the written plan itself. Furthermore, even if written plans are an essential and effective component of successful self-management, the data suggest that few patients receive these plans. If patients and physicians are to increase their use of written plans, the barriers to the use of these plans need further investigation.
DESIGN NARRATIVE:
The three primary outcome measures of this study are as follows: 1) reduction in asthma symptom frequency; 2) reduction in urgent, unscheduled, and emergency visits for asthma; and 3) improved quality of life. These outcomes will be measured over a 12-month period.
The following four secondary outcome measures will also be examined: 1) hospitalizations due to asthma; 2) days with activity restriction; 3) the proportion of patients in the intervention group who are given the model written plan form during the initial visit; and 4) the proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period. These outcomes will be measured over a 12-month period.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL073955-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01HL073955 | NIH | None | https://reporter.nih.gov/quic… | View |