Feasibility of an ED Initiated Online Asthma Management Program for Urban Teens
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 13 - 19 |
Updated: | 3/16/2015 |
Start Date: | October 2012 |
End Date: | November 2013 |
Contact: | Dayna Johnson |
Email: | djohnso3@hfhs.org |
Phone: | (313)874-2888 |
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.
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.
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.
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.
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.
We found this trial at
2
sites
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
Click here to add this to my saved trials
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
Click here to add this to my saved trials