Feasibility of an ED Initiated Online Asthma Management Program for Urban Teens (PuffCityED)

Feasibility of an ED-initiated Online Asthma Management Program for Urban Teens (Puff City-ED)

The objective of this study is to determine the feasibility of conducting a randomized controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated asthma management intervention designed to reduce asthma-related morbidity among urban teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around recruitment, participant compliance with the study protocol, Internet access, and attrition. Investigators will first develop a protocol for recruiting 13-19 year old patients with acute asthma into an ED-initiated pilot trial of an online asthma management program, describing recruitment and refusal rates. Investigators will measure participant compliance with the pilot study protocol including 4 online sessions and a 6 month survey. Investigators will also measure compliance of the participants parents at baseline and a six month follow up. Investigators will then use pilot study results to describe the intervention effect on selected outcomes including ED visits, asthma control as measured by Asthma Control Questionnaire, functional limitations, quality of life, and behavior change.

Study Overview

• Status: Completed
• Conditions: Acute Asthma
• Intervention / Treatment: Behavioral: Tailored asthma management program; Behavioral: Generic web-based education

Detailed Description

Participating emergency departments include Henry Ford Main, Henry Ford Fairlane, and Detroit Medical Center Children's hospital. Eligible teens will be 13-19 years of age. (Including 19 year olds in the the proposed sample means the data is comparable to age categories used by many federal agencies). Eligibility criteria include: a physician diagnosis of acute asthma at the ED visit and parent and teen written informed consent/assent. Eligibility criteria can be confirmed with the help of the ED nursing staff as some teens presenting with symptoms of acute asthma, may receive an asthma diagnosis for the first time in the ED. Using the investigator's data from the school-based trial of Puff City, investigators observed that 12.9% (20/155) of teens reporting an ED visit at baseline also reported no physician diagnosis. This is used as an approximation of the number of participants in the ED pilot that may be newly diagnosed. Teens previously enrolled in the school-based version of Puff City will not be eligible to participate in this pilot. Eligible teens are approached by a recruiter during down time in the ER (while waiting during receiving treatment or while waiting to be discharged). A study recruiter will provide the teen with an enrollment packet that includes an informational brochure (SD 1), a consent (SD 2), and an assent form (SD 3). The recruiter will go through these materials with the parents and teens and answer any questions they may have about the program. The recruited teens who enroll are randomized to either treatment or control. Both groups will be asked to complete an online baseline questionnaire before leaving the ED. An example of this questionnaire has been included with this application (SD 4). Once the baseline questionnaire is finished, teens will then be completing 4 online sessions of web-based asthma education on their own time on a computer with Internet access. Control group will receive commercial websites such as those sponsored by the American Lung Association; the American Academy of Allergy, Asthma and Immunology; the Asthma and Allergy Foundation, and others. Treatment group receives the 4 online, tailored educational sessions. Teens will be encouraged to complete the 4 sessions within 90 days, with a minimum of 7 days between sessions to allow for behavior change. To regulate dosage, control participants receive a "time expired" message after 30 minutes of browsing; this time limit is commensurate with the estimated time needed to complete a tailored session. Teens will also be asked to complete a 6-month follow-up survey (SD 5).Parents/Guardians of the enrolled teens will also be asked to complete a baseline questionnaire and a follow-up at 6 months (SD 6-7) in the form of a telephone interview with a trained interviewer.

In YR1 investigators will develop the recruitment protocol, hire and train recruiters, and establish a study database. Investigators will get on the agenda of CHM ED staff meetings to orient clinic staff to the intervention, obtain input/feedback, discuss logistics, address concerns, and answer questions about the project. Prior to recruitment Investigators will develop signage about the study (as appropriate) for the ED. Recruitment will start in month six of YR1, with at least two practice runs of the protocol. In YR2, investigators will continue recruitment and begin 6 month follow-up surveys. Recruitment will end in the fall of YR2 leaving 6-8 months for completion of follow-up, analysis and write-up. At the end of YR1 and again at the end of YR2, investigators will conduct short, qualitative interviews with ED and research staff to ensure identification of issues, barriers, and obstacles to conducting a trial of an ED-initiated version of Puff City.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 13-19 years of age
• Physician diagnosis of acute asthma at the Emergency Department visit
• Parent written informed consent
• Teen written informed assent

Exclusion Criteria:

• Inability to provide informed consent/assent
• No physician diagnosis of asthma
• Other co-morbidities that make it impossible for individual to participate.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored asthma management program; Teens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management	Behavioral: Tailored asthma management program; web-based, computer-tailored asthma management intervention delivered every week for 4 weeks
Active Comparator: Generic web-based education; Teens in the control group will receive generic, web-based asthma education.	Behavioral: Generic web-based education; Generic, web-based asthma education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visit	Proportion of enrolled teens randomized to the treatment group who return to the ED with acute asthma compared to the proportion of enrolled teens randomized to the control group who return to the ED with acute asthma	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test (ACT)	Comparison of ACT scores at 12 months post-baseline by randomization group	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Status	Compare functional status (e.g., symptom-days, symptom-nights, days of restricted activity, school/work days missed, etc.) by randomization group at 12 months	12 months

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: University of Michigan; Augusta University; Children's Hospital of Michigan
• Investigators: Principal Investigator: Christine LM Joseph, PhD, MPH, Henry Ford Health System

Publications and helpful links

General Publications

• Joseph CLM, Mahajan P, Stokes-Buzzelli S, Johnson DA, Duffy E, Williams R, Zhang T, Ownby DR, Considine S, Lu M. Pilot study of a randomized trial to evaluate a Web-based intervention targeting adolescents presenting to the emergency department with acute asthma. Pilot Feasibility Stud. 2017 Jun 21;4:5. doi: 10.1186/s40814-017-0147-6. eCollection 2018. Erratum In: Pilot Feasibility Stud. 2017 Oct 24;3:48.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Web-based intervention; Emergency department; Acute asthma; Urban adolescents; Computer tailoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1R34HL109296-01A1 (U.S. NIH Grant/Contract)