Full Text View
Tabular View
No Study Results Posted
Related Studies
Written Treatment Plan Versus Usual Care for Treating Individuals With Asthma
This study is ongoing, but not recruiting participants.
Study NCT00149461   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: September 6, 2005   Last Updated: March 10, 2009   History of Changes

September 6, 2005
March 10, 2009
August 2003
April 2009   (final data collection date for primary outcome measure)
  • Reduction in asthma symptom frequency [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Reduction in urgent, unscheduled, and emergency visits for asthma [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Improved quality of life [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • reduction in asthma symptom frequency
  • reduction in urgent, unscheduled, and emergency visits for asthma
  • improved quality of life (all measured over a 12-month period)
Complete list of historical versions of study NCT00149461 on ClinicalTrials.gov Archive Site
  • Hospitalizations due to asthma [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Days with activity restriction [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Proportion of patients in the intervention group who are given the model written plan form during the initial visit [ Time Frame: Measured at Year 4 ] [ Designated as safety issue: No ]
  • Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • hospitalizations due to asthma
  • days with activity restriction
  • proportion of patients in intervention group who are given the model written plan form during initial visit
  • proportion of patients in intervention group who have model treatment plan at end of follow-up period (all measured over a 12-month period)
 
Written Treatment Plan Versus Usual Care for Treating Individuals With Asthma
The Efficacy of Written Treatment Plans in Asthma

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Asthma
Behavioral: Written Treatment Plan
  • Experimental: Patients will receive a written treatment plan from their physician.
  • No Intervention: Patients will not receive a written treatment plan from their physician.
Sheares BJ, Du Y, Vazquez TL, Mellins RB, Evans D. Use of written treatment plans for asthma by specialist physicians. Pediatr Pulmonol. 2007 Apr;42(4):348-56.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
512
June 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • This study will enroll parents of children (ages 3-17 years) with asthma and adult patients with asthma (ages 18-75 years) whe receive care at one of 3 centers (New York Presbyterian Hospital-Columbia campus, New York Presbyterian Hospital-Cornell campus, and Harlem Hospital Center)
  • Diagnosis of persistent asthma (as defined by NHLBI guidelines)
  • Diagnosis of asthma was made using commonly accepted clinical criteria (episodic symptoms of airflow obstruction, airflow obstruction that is at least partially reversible, and reasonable alternative diagnoses have been excluded)
  • Evidence of at least mild persistent asthma, based on the finding of at least one of the following clinical features before treatment:

    1. Presence of symptoms (3 or more days a week)
    2. Nocturnal asthma symptoms (3 or more times a month)
    3. PEF variability of at least 20% to 30%

Exclusion Criteria:

  • Co-morbidity with conditions that affect lung function (e.g, congenital or acquired heart disease, neuromuscular disease, sickle cell disease, or chronic lung disease [bronchopulmonary dysplasia, emphysema, or cystic fibrosis])
Both
3 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00149461
David Evans, PhD, Columbia University
256, R01 HL073955
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Principal Investigator: David Evans, PhD Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP