AsthmaNCT01715389
Evaluation of a Shared Decision Making Portal for Pediatric Asthma
A study testing MyAsthma Patient Portal in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- MyAsthma Patient Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2015
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents/legal guardians of children aged 6-12 with persistent asthma, currently receiving chronic maintenance therapy, cared for at a study practice, with consistent access to a computer with an internet connection where they feel comfortable accessing MyChart (patient portal)
- Clinician at study site
Who cannot join
- parents non-english speaking
- child's primary care provider at the time of enrollment is a pediatric resident
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.
- Conditions
- Asthma
- Being tested
- MyAsthma Patient Portal
- Keywords
- Asthma, Goals, Shared Decision Making, Patient Portal, Electronic Medical Record
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyAsthma Patient PortalOther
Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms. Receives: Other: MyAsthma Patient Portal |
| Control | No intervention | The control group will be signed up for MyChart but not use the MyAsthma Patient Portal. This group will be referred to asthma educational content on the CHOP website, complete study measures and otherwise, receive standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention to parents and clinicians
Parents and clinicians will be asked a series of open-ended questions regarding themes including satisfaction, acceptability and unintended consequences of using the portal for intervention subjects and using MyChart in general for control subjects. Subjects will also be asked a series of Likert-scaled questions related to satisfaction.
Measured: 24 months
Secondary outcomes (10)
Shared decision making
Joint participation in decision-making will be measured by the Observing Parent Involvement (OPTION) scale.
Measured: Baseline
Parent Activation
Parent activation will be measured by the Parent Patient Activation Measure (PPAM).
Measured: 0 months, 3 months, 6 months
Goal Attainment
Parents will identify one or more goals at the study start. Progress toward the goal(s) will be assessed at 3 and 6 month follow-up using Likert-scaled items for the control group, and monthly through use of the portal for the intervention group.
Measured: 0 months, 3 months, 6 months then Monthly
Asthma-Related Quality of Life
Asthma-related quality of life will be measured using The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF)
Measured: 0 months, 6 months
Asthma Control
Asthma control will be assessed using the Pediatric Asthma Control Tool (PACT)
Measured: 0 months, 6 months
Asthma-related Utilization
Utilization will be measured by parent report and chart review by the research team of the following:
Any primary care or subspecialty outpatient encounters relevant to asthma care, asthma-specific acute primary care visits or Urgent Care Center visits, asthma-specific Emergency Room visits, asthma-specific hospital admissions.
Measured: 3 months, 6 months
Asthma Medication Adherence/Receipt
Prescribed medications for the treatment and management of asthma Type and number of prescriptions for asthma
Measured: 6 months
Feasibility of Recruitment
The feasibility of recruitment will be assessed by examining the proportion of all families contacted who meet enrollment criteria and the proportion of families meeting enrollment criteria who enroll.
Measured: 24 months
Feasibility of Follow-up
The feasibility of follow-up will be assessed by the proportion of enrolled families who complete each study measure.
Measured: 24 months
Feasibility of Portal Use
The feasibility of portal use will be assessed by the level of research team/other outside support needed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander G Fiks, MD, MSCF, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715389
- Sponsor's protocol ID
- 12-009407
- Status last verified
- Jun 2015
- First submitted
- 10 Oct 2012
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Shared Decision Making Portal for Pediatric Asthma
- ClinicalTrials.gov ID
- NCT01715389
- Acronym / sponsor ID
- 12-009407
- Conditions
- Asthma
- Keywords
- Asthma, Goals, Shared Decision Making, Patient Portal, Electronic Medical Record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Oct 2012 (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.
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MyAsthma Patient PortalParents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly. Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms. |
| Control | No intervention | –The control group will be signed up for MyChart but not use the MyAsthma Patient Portal. This group will be referred to asthma educational content on the CHOP website, complete study measures and otherwise, receive standard care. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents/legal guardians of children aged 6-12 with persistent asthma, currently receiving chronic maintenance therapy, cared for at a study practice, with consistent access to a computer with an internet connection where they feel comfortable accessing MyChart (patient portal)
- Clinician at study site
Key exclusion criteria (3 listed)
- parents non-english speaking
- child's primary care provider at the time of enrollment is a pediatric resident
- not meeting inclusion criteria
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 |
|---|---|---|
| MyAsthma Patient PortalParents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly. Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms. | Other | Intervention |
Primary outcome
Acceptability of the intervention to parents and clinicians
Time frame: 24 months
Parents and clinicians will be asked a series of open-ended questions regarding themes including satisfaction, acceptability and unintended consequences of using the portal for intervention subjects and using MyChart in general for control subjects. Subjects will also be asked a series of Likert-scaled questions related to satisfaction.
10 secondary outcomes
Shared decision making
Time frame: Baseline
Parent Activation
Time frame: 0 months, 3 months, 6 months
Goal Attainment
Time frame: 0 months, 3 months, 6 months then Monthly
Asthma-Related Quality of Life
Time frame: 0 months, 6 months
Asthma Control
Time frame: 0 months, 6 months
Asthma-related Utilization
Time frame: 3 months, 6 months
Asthma Medication Adherence/Receipt
Time frame: 6 months
Feasibility of Recruitment
Time frame: 24 months
Feasibility of Follow-up
Time frame: 24 months
Feasibility of Portal Use
Time frame: 24 months
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 29 Jun 2015.
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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.
Alexander G Fiks, MD, MSCF principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyAsthma Patient Portal in people with Asthma, run by Children's Hospital of Philadelphia 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 2 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 29 Jun 2015. 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?
Acceptability of the intervention to parents and clinicians (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.