AsthmaNCT04951102
An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
A study testing Electronic Asthma Shared Decision-Making App, Shared Decision Making Physician Training Video and Electronic Asthma Shared Decision-Making App- Patient Data in people with Asthma, run by University of Michigan at 1 site in United States.
Trial summary
This study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Electronic Asthma Shared Decision-Making App, Shared Decision Making Physician Training Video and Electronic Asthma Shared Decision-Making App- Patient Data
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 14 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Diagnosis of persistent asthma
- Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study
Who cannot join
- Diagnosis of intermittent asthma
- Any other lung disease
- Smoking greater than 20 pack years or current smoking
- Mental impairment such that participation would not be possible
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, 48109
About this study
This study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options and make informed choices.
- Conditions
- Asthma
- Being tested
- Electronic Asthma Shared Decision-Making App, Shared Decision Making Physician Training Video, Electronic Asthma Shared Decision-Making App- Patient Data, Standard Care
- Keywords
- Asthma, Shared Decision Making, SDM
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Asthma Shared Decision-Making AppBehavioural
The electronic Asthma SDM App will ask questions related to medicine-related, non-medicine-related, and COVID-19-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment. They may also use the Asthma SDM app to find information about asthma, medication management, COVID-19 and COVID-19 vaccines.
Shared Decision Making Physician Training VideoBehavioural
Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.
Electronic Asthma Shared Decision-Making App- Patient DataBehavioural
Data from the pre-visit electronic Asthma SDM app completed by the patients. Data includes medicine-related, non-medicine-related, and COVID-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment.
Standard CareBehavioural
Standard Care for asthma.
| Study group | Role | What they receive |
|---|---|---|
| Group A Patients who receive SDM intervention | Experimental | Group A patients will complete a pre-visit electronic Asthma SDM App. They may also receive educational information regarding asthma, medication management, smoking cessation, COVID-19 and COVID-19 vaccines. Receives: Behavioral: Electronic Asthma Shared Decision-Making App |
| Group B Patients who receive standard care | Active comparator | Group B patients will receive standard care. Receives: Behavioral: Standard Care |
| Group A Physicians who receive SDM training and electronic Asthma SDM App data | Experimental | Group A physicians will view an SDM Physician Training Video and receive the patients' reported data from the pre-visit asthma SDM App prior to the patients' visits. Receives: Behavioral: Shared Decision Making Physician Training Video; Behavioral: Electronic Asthma Shared Decision-Making App- Patient Data |
| Group B Physicians who provide standard care | Active comparator | Group B physicians will provide standard care. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction as determined by Patient Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-9 (psychometrically validated measures for shared decision-making from the perspectives of patients), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician.
Measured: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit
Secondary outcomes (2)
Physician satisfaction
Physician satisfaction as determined by Physician Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-DOC (psychometrically validated measures for shared decision-making from the perspectives of health care providers), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician. Physicians will receive a small number of satisfaction questionnaires, randomly assigned after patient visits, no more than one a week.
Measured: Within 1 week of patient visit
Change in level of asthma control will be determined
Change in level of asthma control as determined by patient follow up asthma control test questionnaire responses regarding interval changes in asthma control, use of systemic steroids, and urgent care and emergency visits for asthma.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start3 Mar 2021
- Primary completion28 Mar 2022
- Study completion14 Sep 2022
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 University of MichiganThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be clustered in 2 groups of patients and physicians based on participating health care provider and clinic location. Group A will be the intervention group and Group B will be the control group.
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Baptist, University of Michigan
- Investigators
- Alan Baptist, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951102
- Sponsor's protocol ID
- HUM00193830
- Status last verified
- Nov 2022
- First submitted
- 4 Jun 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee DL, Hammond JW, Finkel K, Gardner DD, Nelson B, Baptist AP. An Electronic Shared Decision-Making App to Improve Asthma Outcomes: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2023 Oct;11(10):3116-3122.e5. doi: 10.1016/j.jaip.2023.06.016. Epub 2023 Jun 16.
PubMed 37329951
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
- ClinicalTrials.gov ID
- NCT04951102
- Acronym / sponsor ID
- HUM00193830
- Conditions
- Asthma
- Keywords
- Asthma, Shared Decision Making, SDM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 6 Jul 2021 (actual)
- 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 study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options and make informed choices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The subjects will be clustered in 2 groups of patients and physicians based on participating health care provider and clinic location. Group A will be the intervention group and Group B will be the control group.
| Arm | Type | Receives |
|---|---|---|
| Group A Patients who receive SDM intervention | Experimental | Behavioral: Electronic Asthma Shared Decision-Making AppGroup A patients will complete a pre-visit electronic Asthma SDM App. They may also receive educational information regarding asthma, medication management, smoking cessation, COVID-19 and COVID-19 vaccines. |
| Group B Patients who receive standard care | Active comparator | Behavioral: Standard CareGroup B patients will receive standard care. |
| Group A Physicians who receive SDM training and electronic Asthma SDM App data | Experimental | Behavioral: Shared Decision Making Physician Training Video, Behavioral: Electronic Asthma Shared Decision-Making App- Patient DataGroup A physicians will view an SDM Physician Training Video and receive the patients' reported data from the pre-visit asthma SDM App prior to the patients' visits. |
| Group B Physicians who provide standard care | Active comparator | Behavioral: Standard CareGroup B physicians will provide standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Diagnosis of persistent asthma
- Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study
Key exclusion criteria (4 listed)
- Diagnosis of intermittent asthma
- Any other lung disease
- Smoking greater than 20 pack years or current smoking
- Mental impairment such that participation would not be possible
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 |
|---|---|---|
| Electronic Asthma Shared Decision-Making AppThe electronic Asthma SDM App will ask questions related to medicine-related, non-medicine-related, and COVID-19-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment. They may also use the Asthma SDM app to find information about asthma, medication management, COVID-19 and COVID-19 vaccines. | Behavioural | Group A Patients who receive SDM intervention |
| Shared Decision Making Physician Training VideoTraining video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools. | Behavioural | Group A Physicians who receive SDM training and electronic Asthma SDM App data |
| Electronic Asthma Shared Decision-Making App- Patient DataData from the pre-visit electronic Asthma SDM app completed by the patients. Data includes medicine-related, non-medicine-related, and COVID-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment. | Behavioural | Group A Physicians who receive SDM training and electronic Asthma SDM App data |
| Standard CareStandard Care for asthma. | Behavioural | Group B Patients who receive standard care, Group B Physicians who provide standard care |
Primary outcome
Patient satisfaction
Time frame: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit
Patient satisfaction as determined by Patient Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-9 (psychometrically validated measures for shared decision-making from the perspectives of patients), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician.
2 secondary outcomes
Physician satisfaction
Time frame: Within 1 week of patient visit
Change in level of asthma control will be determined
Time frame: Up to 6 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 17 Nov 2022.
- Derived from this study: PubMed 37329951Lee DL, Hammond JW, Finkel K, Gardner DD, Nelson B, Baptist AP. An Electronic Shared Decision-Making App to Improve Asthma Outcomes: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2023 Oct;11(10):3116-3122.e5. doi: 10.1016/j.jaip.2023.06.016. Epub 2023 Jun 16.
- Individual participant dataSharing planned: No
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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.
Alan Baptist, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Asthma Shared Decision-Making App, Shared Decision Making Physician Training Video and Electronic Asthma Shared Decision-Making App- Patient Data in people with Asthma, run by University of Michigan 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 3 inclusion and 4 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 17 Nov 2022. 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?
Patient satisfaction (time frame: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit). 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 NCT04951102, 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 17 Nov 2022; AzTrials last refreshed its copy on 29 Oct 2026.