Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Written Asthma Actions Plans Versus No Written Instructions In Specialty Care

This study has been completed.
New York Presbyterian Hospital-Cornell
Harlem Hospital Center
Jacobi Medical Center
Information provided by (Responsible Party):
David Evans PhD, Columbia University Identifier:
First received: September 6, 2005
Last updated: January 16, 2014
Last verified: January 2014

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.

Condition Intervention
Behavioral: Written Asthma Action Plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Written Treatment Plans in Asthma

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Reduction in asthma symptom frequency [ Time Frame: Measured at 3 month intervals for 12 months ] [ Designated as safety issue: No ]
    Using a 2-week recall period, asthma symptom frequency was measured in 3 ways: (a) the average number of days with asthma symptoms; (b) the average number of nights with symptoms; and (c) the average number of days the participant used a short-acting bronchodilator.

  • Reduction in urgent, unscheduled, and emergency visits for asthma [ Time Frame: Measured at 3 month intervals for 12 months ] [ Designated as safety issue: No ]
    Emergency, urgent, and unscheduled visits for asthma were combined into a single measure and assessed using a 3-month recall.

  • Improved quality of life [ Time Frame: Measured at 6 and 12 months ] [ Designated as safety issue: No ]
    Asthma QOL, using the Juniper Mini Asthma QOL Scale (MiniAQLQ) for adult participants and the Juniper Pediatric Asthma Caregivers QOL Questionnaire (PACQLQ) for parents, was assessed at 6 and 12-months follow-up.

Secondary Outcome Measures:
  • Hospitalizations due to asthma [ Time Frame: Measured at 3 month intervals for 12 months ] [ Designated as safety issue: No ]
    Assessed the number of hospital admissions over the previous 3 months.

  • Days with activity restriction [ Time Frame: Measured at 3 month intervals for 12 months ] [ Designated as safety issue: No ]
    Days with activity limitations were defined as the number of days missed from school or work due to asthma.

  • Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit [ Time Frame: Measured at the exit interview after the initial visit with the specialist physician ] [ Designated as safety issue: No ]
    Participants in each group show the research assistant all written materials they received from the physician during the visit.

  • 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 12 month interview ] [ Designated as safety issue: No ]
    Assessed retention of the written asthma action plan (WAAP) by asking participants to read a specific line from the written asthma action plan to demonstrate that they had the WAAP in their possession.

Enrollment: 407
Study Start Date: September 2006
Study Completion Date: July 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Written Asthma Action Plan Group
Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician.
Behavioral: Written Asthma Action Plan
Other Names:
  • Asthma Treatment Plans
  • Action Plans
No Intervention: No Written Instructions Group
Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician.

Detailed Description:


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.


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.


Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • This study will enroll parents of children (ages 5-17 years) with asthma and adult patients with asthma (ages 18-80 years) who receive care at one of 4 New York Ciry medical centers (New York Presbyterian Hospital-Columbia campus, New York Presbyterian Hospital-Cornell campus, Harlem Hospital Center, and Jacobi Medical Center)
  • Diagnosis of persistent asthma (as defined by NHLBI guidelines)
  • All participants are new patients to the practice
  • Had never been seen by a specialist physician for asthma care
  • Had never received a written asthma action plan

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])
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00149461

United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
New York Presbyterian Hospital-Cornell
Harlem Hospital Center
Jacobi Medical Center
Principal Investigator: David Evans, PhD Columbia University
  More Information

Responsible Party: David Evans PhD, Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics), Columbia University Identifier: NCT00149461     History of Changes
Other Study ID Numbers: AAAA0864, R01HL073955-01, R01 HL073955
Study First Received: September 6, 2005
Last Updated: January 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Columbia University:
Asthma Action Plans
African Americans
Health Literacy
Asthma Education

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on March 01, 2015