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AsthmaFLOATNCT03894982

Family Learning on Asthma Topics

An observational study of Asthma, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 4 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Group Classes
How many people
10 participants
Where
1 siteUnited States
Study dates
5 May 2019to 31 May 2020
Phase
Observational
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 4 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Hospital Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

  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. 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. 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.
Read the detailed description
  1. Hypotheses and Specific Aims:
  2. 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.
  3. 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.
  4. 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.

II. Background and Significance:

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. The Centers for Disease Control and Prevention surveillance data reports that at a national level, health care use for emergency department services for asthma was 1.6 million in 2013, and that of 439,435 hospital admissions for asthma 136,669 or 31% are for children below the age of 18 years of age. The annual cost of asthma on the U.S. economy equates to more than $80 billion in medical expenses, including days missed from school, work and even death. Nurmagambetov, et.al. in their study state that the "combined costs of medical care, mortality, and absenteeism render the total cost of asthma a substantial and serious economic burden on society. These findings highlight the critical need to support and further strengthen asthma control strategies through increased provision of guideline-based care, improvements in self-management, and reduction of environmental asthma triggers to reduce ER visits, hospitalizations, absenteeism, and mortality".

Bäuerle et al. used a prospective single-center controlled trial to show that by providing motivating and patient-oriented didactics on asthma, there is a statistically significant increase in asthma health outcomes and that asthma control can be improved by education measures. Although it is a key component of all international asthma guidelines, education in self-management is still insufficiently available in primary care settings. In the ambulatory setting, there are some families that require more extensive education and time is limited in a usual care appointment to address all their specific asthma needs.

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. According to Srof et al., asthma management education programs should be connected to the chronic illness management within the fabric of the family system. The paradigm of group education supports engagement, promoting communication among all participants including facilitator to enhance a social construct for validating personal experiences, empowering caregivers, and solving asthma management problems.

III. Preliminary Studies/Progress Report: none

IV. Research Methods

  1. Outcome Measure(s):

Decrease emergency room visits, hospitalizations, and systemic steroid use for each child 12 months after completing the three, group classroom educational sessions.

  1. Description of Population to be Enrolled: The investigators will enroll legal guardians and or primary caregiver (18 years and older) of children 4-17 years of age along with those 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.
  2. Study Design and Research Methods: Patients and caregivers will be recruited from the Pulmonary outpatient clinic and inpatient services at Children's Hospital Colorado. Patients will also be referred to the Family Learning on Asthma Topic (F.L.O.A.T) program by health care providers participating in these clinics/inpatient service. Children will be: 1) 4-17 years age, 2) have poor evidence of asthma control based on > 2 systemic steroid courses; > 2 Emergency Room visits; and >1 hospitalization for asthma exacerbation in the preceding 12 months. The investigators anticipate to enroll 75 patients and enrollment to begin in the Spring 2019 through the Spring 2020. 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. An in person Spanish asthma educator will be available to help teach the classes. The materials used for each class were created by the CHCO Health Literacy Team in collaboration with Asthma Educator Certified members of the Breathing Institute to ensure that evidence-based information will be communicated effectively to patients and families. Instead of a lecture style course, each class will facilitate interactive learning for patients and families to help them prepare for real life problem-solving and to promote self-awareness regarding medication use. Patient and families enrolled will be notified of the class schedule and receive reminders 1 week and the day before each of their classes either through email, phone call and or text messaging. There will be a general asthma knowledge questionnaire consisting of 12 questions and the standardized Asthma Control Test (ACT) that consists of 7 standardized questions, one for children 4 - 11 years of age and one for children 12 years and older, that participants will fill out at the start of their first class. After each class, there will be 4 questions to be answered regarding their understanding of that class. Handouts and visuals will be available in English and Spanish pertaining to information about that class. Other class materials will include a folder to keep their handouts in and paper and pencils for note taking. Peak flow meters and their Asthma Action Plans will also be provided. At the completion of the class series there will be a satisfaction survey, participants will fill out anonymously. Twelve months following the completion of the class series, the investigators will be conducting a chart review gathering data on frequency of emergency room visits, hospitalizations and systemic steroid use for asthma exacerbations along with any routine follow up visits for asthma.
  3. Description, Risks and Justification of Procedures and Data Collection Tools:

Data collected will be through pre and post class questionnaires, Asthma Control Test (ACT), validated Inhaler Technique Assessment Tool (iDAT), and demographic information filled out by the families and noted in their EMR (EPIC). Information about participant's asthma care utilization and systemic steroid use will be obtained through EMR/EPIC chart review, 12 months prior to enrollment and 12 months post last completed class. All information will be entered in to a secure REDCap data base and paper copies will be kept in the locked research cabinet of study personnel.

  1. Potential Scientific Problems: The investigators do not anticipate any scientific problems
  2. Data Analysis Plan:

Inclusion requirements will be defined through the electronic medical record based on inclusion requirements by either the outpatient pulmonary team or inpatient asthma education team.

After enrollment the following information will be placed into RedCap (HIPPA compliant database) from the EMR: Childs name, DOB, Race, Ethnicity, Cell phone number, Email, Zip Code, Sex, Preferred language (caregiver), Pulmonary or Allergy specialist seen within the previous year, Payer, Hospital visits (ED and hospital visits) 12 months prior to consent.

Right after enrollment a pre-knowledge base survey of 12 questions and asthma control survey of 7 questions will be sent via RedCap to caregivers defined phone and email. The data will be collected electronically and stored in RedCap.

Throughout the 4-month study period, every week an administrative support person will pull the child's name, caregivers name, designated contact phone number, and email from RedCap databased to send a text, email, and phone call reminders of upcoming classes and asking the caregiver to reply electronically if they are planning on attending. The administrative assistant will review the reply's and notify the educators of the number of class attendees and their names.

Upon completing each of the three classes the instructor will ask for the administrative assistant to send a post knowledge bases survey of 4 questions out of RedCap to the primary caregiver. The electronic responses will be electronically entered into RedCap.

Upon completion of the 3 classes and/or 4months the administrative assistant will send a post-knowledge survey consisting of 12 questions, an asthma control test survey of 7 questions, and a satisfaction survey to the primary caregiver. The electronic responses will be entered into RedCap.

Each quarter the overview of pre-knowledge base survey results, post-knowledge survey results and satisfaction survey will be reviewed by the team members to evaluate if any changes need to be made to the education curriculum.

Child specific data will be reviewed 12 months after completion of the classes and/or study.

  1. Summarize Knowledge to be Gained:

By conducting this group focused asthma education series for high risk asthmatics and their care givers, the investigators anticipate improved knowledge along with retention of knowledge gained through these classes thereby reducing exacerbations, and need for acute care interventions. Group centered learning will enhance opportunities to learn from others who may have similar experiences and will generate discussion and new skills and ideas.

Conditions
Asthma
Being tested
Group Classes
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group ClassesOther

    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.

Study groups in NCT03894982
Study groupRoleWhat they receive
What is AsthmaReviewing 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.
Receives: Other: Group Classes
TriggersReviewing 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.
Receives: Other: Group Classes
Medications and Asthma Action PlanReview what is an asthma action plan, how to use an asthma action and the medications listed on each individuals plan.
Receives: Other: Group Classes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change the number of hospital visits of participants with asthma

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

    Measured: 12 months from completion of the classroom sessions

  2. 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

    Measured: 12 months from completion of the classroom sessions

  3. 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

    Measured: 12 months from completion of the educational sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start5 May 2019
  3. Primary completion31 May 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894982
Sponsor's protocol ID
19-0442
Acronym
FLOAT
Status last verified
Jul 2020
First submitted
27 Mar 2019
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

  • 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.

    PubMed 29323930
  • 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.

    PubMed 27993435
  • 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.

    PubMed 26162708
  • 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.

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

    PubMed 23189776
  • 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).

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by University of Colorado, Denver 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 3 inclusion and 3 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 4 Aug 2020. 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?

Change the number of hospital visits of participants with asthma (time frame: 12 months from completion of the classroom sessions). 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 NCT03894982, which also lists 7 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 4 Aug 2020.

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