NCT03894982

Brief Summary

  1. 1.Hypothesis: The Family Learning on Asthma Topics (F.L.O.A.T) in the form of a a group teaching environment for family education stemming from standardized education materials on asthma, created and taught by nationally certified asthma educators will promote optimal asthma knowledge, management and quality of life among the individuals with asthma and their caregivers.
  2. 2.Aim 1: To determine if the availability of educational services outside of regular clinic hours or admission status could improve asthma outcomes and decrease unnecessary medical utilization.
  3. 3.Aim 2: By providing small-group learning environments for families, the investigators aim to encourage families to learn from each other's experiences and to decrease stigma around the disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

March 27, 2019

Last Update Submit

July 31, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change the number of hospital visits of participants with asthma

    Change the number of hospital visits of participants with asthma through comprehensive asthma education

    12 months from completion of the classroom sessions

  • Change the number of emergency room or urgent care visits of participants with asthma

    Change the number of emergency room or urgent care visits of participants with asthma through comprehensive asthma education

    12 months from completion of the classroom sessions

  • Change the amount of oral steroids taken by the participants for asthma exacerbations

    Change the amount of oral steroids taken by participants for asthma exacerbation through comprehensive asthma education

    12 months from completion of the educational sessions

Study Arms (3)

What is Asthma

Reviewing asthma is a lung disease. There is no cure, but asthma can be well controlled so that your child can be healthy and join in all their favorite activities. Asthma causes the airways (breathing tubes in the lungs) to get smaller, making it hard to breathe.Common symptoms of asthma are coughing, wheezing, chest tightness and trouble breathing. These symptoms are ongoing and get better with asthma medicines.

Other: Group Classes

Triggers

Reviewing specifics around children with asthma have extra sensitive airways and many things around them can make their asthma worse. The things around your child that cause an asthma attack are called triggers. Triggers are different for each child. Your doctor can help you figure out your child's triggers. Try to keep your child away from their triggers, especially at home and at school where your child spends most of their time.

Other: Group Classes

Medications and Asthma Action Plan

Review what is an asthma action plan, how to use an asthma action and the medications listed on each individuals plan.

Other: Group Classes

Interventions

Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support teaching methods that include standardized instructions. There will be three topics lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers, Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline recommendations to ensure the continuity of messaging. Each class size will be approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and will be held in the Family Learning Center at the Children's Hospital Colorado. Classes will be taught in both English and Spanish.

Medications and Asthma Action PlanTriggersWhat is Asthma

Eligibility Criteria

Age4 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Despite recent improvements in treatment and the ongoing research in better understanding of the disease, emergency room visits and hospitalization rates for asthma remain high, with 31% of these visits are children below the age of 18 years of age. Providing patient education by an experienced asthma educator is an important step in supporting patients and families as they are diagnosed with asthma and as they adapt to life with a chronic condition. Educating families about the nature of the disease, triggers, identification of early signs and symptoms, principles of treatment, and asthma management can reduce children's use of acute care services.

You may qualify if:

  • Legal guardians and or primary caregiver (18 years and older) of children 4-17 years of age
  • Children/adolescents who have a diagnosis of asthma, and have documented poor control as evidenced by requiring two or more systemic steroids, one or more hospitalizations and/or two or more ED visits due to asthma in the 12 months prior to the asthma clinic or hospital visit.
  • Patients and caregivers will be English or Spanish speaking.

You may not qualify if:

  • children \< 4 yrs of age
  • children with multiple chronic lung diseases
  • Children and families whose primary language is other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (7)

  • CDC - Asthma - Data and Surveillance - Asthma Surveillance Data. (2016, September 8). Retrieved from https://www.cdc.gov/asthma/asthmadata.htm

    BACKGROUND
  • Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.

    PMID: 29323930BACKGROUND
  • Bauerle K, Feicke J, Scherer W, Sporhase U, Bitzer EM. Evaluation of a standardized patient education program for inpatient asthma rehabilitation: Impact on patient-reported health outcomes up to one year. Patient Educ Couns. 2017 May;100(5):957-965. doi: 10.1016/j.pec.2016.11.023. Epub 2016 Nov 28.

    PMID: 27993435BACKGROUND
  • Boulet LP, Boulay ME, Gauthier G, Battisti L, Chabot V, Beauchesne MF, Villeneuve D, Cote P. Benefits of an asthma education program provided at primary care sites on asthma outcomes. Respir Med. 2015 Aug;109(8):991-1000. doi: 10.1016/j.rmed.2015.05.004. Epub 2015 May 14.

    PMID: 26162708BACKGROUND
  • Srof B, Taboas P, Velsor-Friedrich B. Adolescent asthma education programs for teens: review and summary. J Pediatr Health Care. 2012 Nov-Dec;26(6):418-26. doi: 10.1016/j.pedhc.2011.03.010. Epub 2011 May 12.

    PMID: 23099308BACKGROUND
  • McCarty K, Rogers J. Inpatient asthma education program. Pediatr Nurs. 2012 Sep-Oct;38(5):257-62, 269; quiz 263.

    PMID: 23189776BACKGROUND
  • National Heart Lung and Blood Institute (US). Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma Clinical Practice Guidelines National Asthma Education and Prevention Program, Third Expert Panel on the Diagnosis and Management of Asthma. http://www.nhlbi.nih. gov/guidelines/asthma/asthgdln.htm (Accessed March 19 2018).

    BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Stan Szefler, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

May 5, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations