AsthmaNCT00149461
Written Asthma Actions Plans Versus No Written Instructions In Specialty Care
A study testing Written Asthma Action Plan in people with Asthma, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Written Asthma Action Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Written Asthma Action Plan
- Keywords
- Asthma Action Plans, African Americans, Latinos, Health Literacy, Asthma Education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Asthma Action PlanBehavioural
Also called Asthma Treatment Plans, Action Plans
| Study group | Role | What they receive |
|---|---|---|
| Written Asthma Action Plan Group | Experimental | Participants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician. Receives: Behavioral: Written Asthma Action Plan |
| No Written Instructions Group | No intervention | Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in asthma symptom frequency
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.
Measured: Measured at 3 month intervals for 12 months
Reduction in urgent, unscheduled, and emergency visits for asthma
Emergency, urgent, and unscheduled visits for asthma were combined into a single measure and assessed using a 3-month recall.
Measured: Measured at 3 month intervals for 12 months
Improved quality of life
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.
Measured: Measured at 6 and 12 months
Secondary outcomes (4)
Hospitalizations due to asthma
Assessed the number of hospital admissions over the previous 3 months.
Measured: Measured at 3 month intervals for 12 months
Days with activity restriction
Days with activity limitations were defined as the number of days missed from school or work due to asthma.
Measured: Measured at 3 month intervals for 12 months
Proportion of participants in the intervention group who are given the written asthma action plan form during the initial visit
Participants in each group show the research assistant all written materials they received from the physician during the visit.
Measured: Measured at the exit interview after the initial visit with the specialist physician
Proportion of patients in the intervention group who have the model treatment plan at the end of the follow-up period
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.
Measured: Measured at 12 month interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), New York Presbyterian Hospital-Cornell, Harlem Hospital Center, Jacobi Medical Center
- Responsible party
- Principal investigator, David Evans PhD, Columbia University
- Investigators
- David Evans, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149461
- Sponsor's protocol ID
- AAAA0864
- Other IDs
- R01HL073955-01, R01HL073955
- Status last verified
- Jan 2014
- First submitted
- 6 Sep 2005
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1002/ppul.20586.
PubMed 17352397Sheares BJ, Mellins RB, Dimango E, Serebrisky D, Zhang Y, Bye MR, Dovey ME, Nachman S, Hutchinson V, Evans D. Do Patients of Subspecialist Physicians Benefit from Written Asthma Action Plans? Am J Respir Crit Care Med. 2015 Jun 15;191(12):1374-83. doi: 10.1164/rccm.201407-1338OC.
PubMed 25867075
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Written Treatment Plans in Asthma
- ClinicalTrials.gov ID
- NCT00149461
- Acronym / sponsor ID
- AAAA0864
- Conditions
- Asthma
- Keywords
- Asthma Action Plans, African Americans, Latinos, Health Literacy, Asthma Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), New York Presbyterian Hospital-Cornell, Harlem Hospital Center, Jacobi Medical Center
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Asthma Action Plan Group | Experimental | Behavioral: Written Asthma Action PlanParticipants randomized to the written asthma action plan group received an asthma action plan form along with asthma education from their specialist physician. |
| No Written Instructions Group | No intervention | –Participants randomized to the usual care group received no written instructions other than prescriptions from their specialist physician. |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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])
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 |
|---|---|---|
| Written Asthma Action PlanAlso: Asthma Treatment Plans, Action Plans | Behavioural | Written Asthma Action Plan Group |
Primary outcome
Reduction in asthma symptom frequency
Time frame: Measured at 3 month intervals for 12 months
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
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
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.
4 secondary outcomes
Hospitalizations due to asthma
Time frame: Measured at 3 month intervals for 12 months
Days with activity restriction
Time frame: Measured at 3 month intervals for 12 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Results publication: PubMed 17352397Sheares 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. doi: 10.1002/ppul.20586.
- Derived from this study: PubMed 25867075Sheares BJ, Mellins RB, Dimango E, Serebrisky D, Zhang Y, Bye MR, Dovey ME, Nachman S, Hutchinson V, Evans D. Do Patients of Subspecialist Physicians Benefit from Written Asthma Action Plans? Am J Respir Crit Care Med. 2015 Jun 15;191(12):1374-83. doi: 10.1164/rccm.201407-1338OC.
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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.
David Evans, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Asthma Action Plan in people with Asthma, run by Columbia University at 1 site 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 5 inclusion and 1 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 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in asthma symptom frequency (time frame: Measured at 3 month intervals for 12 months). The study lists 3 primary outcomes in all. 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 NCT00149461, which also lists 2 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 17 Jan 2014.