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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Henry Ford Health System
Sponsor:
Collaborators:
University of Michigan
Children's Hospital of Michigan
Georgia Regents University
Information provided by (Responsible Party):
Christine Joseph, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01695031
First received: September 12, 2012
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Acute Asthma
Behavioral: Tailored asthma management program
Behavioral: Generic web-based education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Feasibility of an ED-initiated Online Asthma Management Program for Urban Teens (Puff City-ED)

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Emergency Department Visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Asthma Control Test (ACT) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison of ACT scores at 12 months post-baseline by randomization group


Other Outcome Measures:
  • Functional Status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare functional status (e.g., symptom-days, symptom-nights, days of restricted activity, school/work days missed, etc.) by randomization group at 12 months


Estimated Enrollment: 170
Study Start Date: October 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT01695031

Contacts
Contact: Dayna Johnson (313)874-2888 djohnso3@hfhs.org
Contact: Tara Andrews (313)874-7052 tandrew1@hfhs.org

Locations
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Dayna Johnson, MPH    313-874-2888    djohnso1@hfhs.org   
Principal Investigator: Christine LM Joseph, PhD, MPH         
Sub-Investigator: Stephanie Stokes-Buzzelli, MD         
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Elizabeth Duffy, MA, CCRP    313-966-0325    eduffy@dmc.org   
Principal Investigator: Prashant Mahajan, MD, MPH, MBA         
Sponsors and Collaborators
Henry Ford Health System
University of Michigan
Children's Hospital of Michigan
Georgia Regents University
Investigators
Principal Investigator: Christine LM Joseph, PhD, MPH Henry Ford Health System
  More Information

No publications provided

Responsible Party: Christine Joseph, Senior Scientist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01695031     History of Changes
Other Study ID Numbers: 1R34HL109296-01A1
Study First Received: September 12, 2012
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Henry Ford Health System:
Urban adolescents
Acute asthma
Emergency department
Computer tailoring
Web-based intervention

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2014