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CompletedNCT04951102Updated Nov 17, 2022

An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

An interventional study of Electronic Asthma Shared Decision-Making App and Shared Decision Making Physician Training Video in Asthma, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by University of Michigan · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Mar 2021, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Shared Decision Making
  • SDM
03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 81 is close to the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • English speaking
  • Diagnosis of persistent asthma
  • Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Group A Patients who receive SDM intervention

    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.

    Behavioral: Electronic Asthma Shared Decision-Making App

  • Active comparator
    Group B Patients who receive standard care

    Group B patients will receive standard care.

    Behavioral: Standard Care

  • Experimental
    Group A Physicians who receive SDM training and electronic Asthma SDM App data

    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.

    Behavioral: Shared Decision Making Physician Training Video · Behavioral: Electronic Asthma Shared Decision-Making App- Patient Data

  • Active comparator
    Group B Physicians who provide standard care

    Group B physicians will provide standard care.

    Behavioral: Standard Care

Interventions

  • BehavioralElectronic Asthma Shared Decision-Making App

    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.

  • BehavioralShared Decision Making Physician Training Video

    Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.

  • BehavioralElectronic Asthma Shared Decision-Making App- Patient Data

    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.

  • BehavioralStandard Care

    Standard Care for asthma.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit

Secondary outcomes

  1. 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.

    Time frame: Within 1 week of patient visit

  2. 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.

    Time frame: Up to 6 months

07

Study locations

1 site
  • Michigan Medicine, University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Mar 2022, 12 months.

Of 466 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's 12 months is below that.

Counting every sponsor, half of 502 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2021
First posted
Jul 6, 2021
StartActual
Mar 3, 2021
Primary completionActual
Mar 28, 2022
CompletionActual
Sep 14, 2022
Last update
Nov 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04951102
Responsible party
Alan Baptist (Assistant Professor of Internal Medicine, University of Michigan) — Principal investigator
First posted
Jul 6, 2021
Start date
Mar 3, 2021
Primary completion
Mar 28, 2022
Completion
Sep 14, 2022
Last update
Nov 17, 2022

Study contacts

Alan Baptist, MD
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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