AsthmaPhase 2/3NCT00921401
Improving the Quality of Asthma Care Using the Internet
A Phase 2/3 study testing Asthma Feedback in people with Asthma, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Feb 2013
- Phase
- Phase 2/3
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Only individuals with persistent asthma will be considered for this study. These definitions are made based on definitions from the National Committee for Quality Assurance (NCQA) and include individuals who meet either criteria A or B:
- A: (Four or more prescription medications used for asthma treatment in 1 year) OR (One or more visits to the emergency room with a principal diagnosis of asthma in 1 year) OR (One or more inpatient hospital visits with a principal diagnosis of asthma in 1 year)
- B: (Four or more outpatient visits with any diagnosis of asthma) AND (two or more claims for a prescription drug used for asthma treatment in 1 year)
- Other Inclusion Criteria:
- Speaks and reads English fluently
- Member of Highmark
Show all 10Show fewer
- Has access to the Internet at home or at work
- Has a valid e-mail address
- No history of more than 20 pack-years of cigarette smoking
- Enrolled in a Highmark health plan offering that includes prescription drug coverage
Who cannot join
- Does not speak English
- Does not have Internet access at home or work
- Smoked more than 20 pack-years (to exclude possible chronic obstructive pulmonary disease [COPD])
- Does not currently have asthma
- Pregnant
- Unwilling to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center, Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care.
Read the detailed description
Asthma is a common cause of illness and lost productivity, including missed days of work and school, in the United States. It is important for people with asthma to become involved in their treatment and care. Previous studies have shown that encouraging people to ask their doctor for various medical tests and treatments improves preventive care (e.g., cancer screenings), but more research is needed on the effect this can have on asthma management. This study will involve an interactive Web site that will ask patients questions about their asthma symptoms and medications and provide suggestions and feedback on the types of questions patients may want to ask their doctors. By asking questions about their asthma care and increasing communication with their doctor, patients may experience improved quality of asthma care and better asthma control. The purpose of this study is to evaluate the impact of the interactive Web site on asthma control and other measures of asthma management.
This 12-month study will enroll people with asthma. Participants will be randomly assigned to either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will log in to the study Web site at least once a month for 12 months and before all doctor visits. After logging in to the Web site, participants in the Asthma Feedback group will answer a series of questions about their asthma care. They will then receive information and feedback on the types of questions they should ask their asthma care provider during their next office visit. Participants in the Preventive Feedback group will answer questions and receive information and feedback regarding preventive services (e.g., cancer screening, cholesterol screening) that they should discuss with their primary care provider. At baseline and Months 6 and 12, all participants will complete online questionnaires regarding their asthma and overall health. Study researchers will review participants' medical records and insurance claims data at the end of the study.
- Conditions
- Asthma
- Being tested
- Asthma Feedback
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma FeedbackBehavioural
All participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Feedback | Experimental | Each month and before all visits with their asthma care provider, participants will be encouraged to go online and answer a series of questions regarding the types of asthma medications they use and how often they use them, asthma symptoms they have experienced, emergency department visits in the past year, the care they have received for their asthma (e.g., specialist visits) in the past year, and the planned date of their next visit with their asthma care provider. Participants will receive tailored feedback about what questions they should ask their doctor during a subsequent visit, whether or not they should schedule a visit sooner, and links to read more about each recommendation. Receives: Behavioral: Asthma Feedback |
| Preventive Feedback | Active comparator | Each month and before all visits with their primary care provider, participants will be encouraged to go online and answer a series of questions regarding their preventive care. They will receive tailored feedback regarding preventive services, such as pap testing, cancer screenings, and flu shots. Participants will receive tailored feedback regarding preventive services (e.g., cancer screening) that they should discuss with their primary care provider. Receives: Behavioral: Asthma Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control - as measured by the Asthma Control Test
Measured: Measured at Year 1
Secondary outcomes (3)
Medication adherence, as measured by claims data
Measured: Measured at Year 1
Outpatient provider visits, as measured by claims data
Measured: Measured at Year 1
Asthma-related emergency department visits, as measured by claims data
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher N Sciamanna, MD, MPH, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921401
- Sponsor's protocol ID
- 662
- Other IDs
- 5R01HL088590-02
- Status last verified
- May 2013
- First submitted
- 15 Jun 2009
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Pool AC, Kraschnewski JL, Poger JM, Smyth J, Stuckey HL, Craig TJ, Lehman EB, Yang C, Sciamanna CN. Impact of online patient reminders to improve asthma care: A randomized controlled trial. PLoS One. 2017 Feb 3;12(2):e0170447. doi: 10.1371/journal.pone.0170447. eCollection 2017.
PubMed 28158200
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Asthma Care Using the Internet
- ClinicalTrials.gov ID
- NCT00921401
- Acronym / sponsor ID
- 662
- Conditions
- Asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Penn State University
- Study start
- Aug 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care.
Detailed description
Asthma is a common cause of illness and lost productivity, including missed days of work and school, in the United States. It is important for people with asthma to become involved in their treatment and care. Previous studies have shown that encouraging people to ask their doctor for various medical tests and treatments improves preventive care (e.g., cancer screenings), but more research is needed on the effect this can have on asthma management. This study will involve an interactive Web site that will ask patients questions about their asthma symptoms and medications and provide suggestions and feedback on the types of questions patients may want to ask their doctors. By asking questions about their asthma care and increasing communication with their doctor, patients may experience improved quality of asthma care and better asthma control. The purpose of this study is to evaluate the impact of the interactive Web site on asthma control and other measures of asthma management.
This 12-month study will enroll people with asthma. Participants will be randomly assigned to either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will log in to the study Web site at least once a month for 12 months and before all doctor visits. After logging in to the Web site, participants in the Asthma Feedback group will answer a series of questions about their asthma care. They will then receive information and feedback on the types of questions they should ask their asthma care provider during their next office visit. Participants in the Preventive Feedback group will answer questions and receive information and feedback regarding preventive services (e.g., cancer screening, cholesterol screening) that they should discuss with their primary care provider. At baseline and Months 6 and 12, all participants will complete online questionnaires regarding their asthma and overall health. Study researchers will review participants' medical records and insurance claims data at the end of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Feedback | Experimental | Behavioral: Asthma FeedbackEach month and before all visits with their asthma care provider, participants will be encouraged to go online and answer a series of questions regarding the types of asthma medications they use and how often they use them, asthma symptoms they have experienced, emergency department visits in the past year, the care they have received for their asthma (e.g., specialist visits) in the past year, and the planned date of their next visit with their asthma care provider. Participants will receive tailored feedback about what questions they should ask their doctor during a subsequent visit, whether or not they should schedule a visit sooner, and links to read more about each recommendation. |
| Preventive Feedback | Active comparator | Behavioral: Asthma FeedbackEach month and before all visits with their primary care provider, participants will be encouraged to go online and answer a series of questions regarding their preventive care. They will receive tailored feedback regarding preventive services, such as pap testing, cancer screenings, and flu shots. Participants will receive tailored feedback regarding preventive services (e.g., cancer screening) that they should discuss with their primary care provider. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Only individuals with persistent asthma will be considered for this study. These definitions are made based on definitions from the National Committee for Quality Assurance (NCQA) and include individuals who meet either criteria A or B:
- A: (Four or more prescription medications used for asthma treatment in 1 year) OR (One or more visits to the emergency room with a principal diagnosis of asthma in 1 year) OR (One or more inpatient hospital visits with a principal diagnosis of asthma in 1 year)
- B: (Four or more outpatient visits with any diagnosis of asthma) AND (two or more claims for a prescription drug used for asthma treatment in 1 year)
- Speaks and reads English fluently
- Member of Highmark
Key exclusion criteria (6 listed)
- Does not speak English
- Does not have Internet access at home or work
- Smoked more than 20 pack-years (to exclude possible chronic obstructive pulmonary disease [COPD])
- Does not currently have asthma
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma FeedbackAll participants will log in to the study Web site at least once a month and before all doctor visits. They will answer a series of questions and receive individualized feedback about the types of questions they should ask their doctor. | Behavioural | Asthma Feedback, Preventive Feedback |
Primary outcome
Asthma control - as measured by the Asthma Control Test
Time frame: Measured at Year 1
3 secondary outcomes
Medication adherence, as measured by claims data
Time frame: Measured at Year 1
Outpatient provider visits, as measured by claims data
Time frame: Measured at Year 1
Asthma-related emergency department visits, as measured by claims data
Time frame: Measured at Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Derived from this study: PubMed 28158200Pool AC, Kraschnewski JL, Poger JM, Smyth J, Stuckey HL, Craig TJ, Lehman EB, Yang C, Sciamanna CN. Impact of online patient reminders to improve asthma care: A randomized controlled trial. PLoS One. 2017 Feb 3;12(2):e0170447. doi: 10.1371/journal.pone.0170447. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher N Sciamanna, MD, MPH principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Asthma Feedback in people with Asthma, run by Milton S. Hershey Medical Center 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 10 inclusion and 6 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 7 May 2013. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Asthma control - as measured by the Asthma Control Test (time frame: Measured at Year 1). 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 NCT00921401, which also lists 1 linked publication.
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 7 May 2013.