AsthmaSOARNCT05722834
Self-regulation for Older Adults With Asthma Through Remote Education
A study testing SOAR intervention in people with Asthma, run by University of Michigan at 3 sites in United States.
Trial summary
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for asthma. The purpose of this study is to implement and evaluate an asthma self-management intervention through multiple locations in the United States that is tailored to the challenges older adults… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- SOAR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2023to 31 May 2024
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of asthma
- Poorly controlled asthma, as evidenced by a score ≤ 19 on the Asthma Control Test
- Have a primary care provider willing to participate in the study by receiving email updates regarding the status of the participant
Who cannot join
- Physician diagnosis of any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)
- A greater than 20 pack-year smoking history
- Lack of telephone access
- Decreased cognitive capacity such that participation in the program would not be possible
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Vermont
Burlington, Vermont, 05405
University of Illinois-Chicago
Chicago, Illinois, 60607
About this study
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for asthma.
The purpose of this study is to implement and evaluate an asthma self-management intervention through multiple locations in the United States that is tailored to the challenges older adults face and is based on an individual behavioral theory of change.
Eligible participants will be enrolled and participate for six weeks in the SOAR intervention.
- Conditions
- Asthma
- Being tested
- SOAR intervention
- Keywords
- Asthma education, Self-Regulation, Remote education, Counseling
- Medical subject headings
- Asthma, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOAR interventionBehavioural
This program intervention will be over 6 weeks and participants will have two group sessions and individual sessions, all conducted by an asthma health coach over Zoom (or phone). The two Zoom group sessions will be recorded so that all the information from the conversations will be maintained and used for research purposes. Additionally, participants will keep track of asthma symptoms and complete surveys at specified time-points (the last one at 6 months after participation).
Primary care physicians will be sent emails regarding the self-management goals of their patients.
| Study group | Role | What they receive |
|---|---|---|
| SOAR intervention | Experimental | The SOAR intervention will be a remote intervention that will follow a self-regulation process in which the participant first selects a specific problem to address and researches how asthma is preventing resolution of the problem, and finally identifies and develops a plan to achieve the objective. Receives: Behavioral: SOAR intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers
A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived feasibility.
Measured: Day 43
Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived acceptability.
Measured: Day 43
Intervention Appropriateness Measure (IAM) for patients and providers
This is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived appropriateness.
Measured: Day 43
Secondary outcomes (6)
Change in Asthma control will be determined with the Asthma Control Test (ACT)
Asthma Control Test (ACT) has 5 questions. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: baseline to 6 months
Change in Perceived Control of Asthma Questionnaire (PCAQ)
This questionnaire has 11 questions. Responses are graded on a 5-point scale, scoring between 11 and 55, with higher scores reflecting greater perceived control of asthma.
Measured: baseline to 6 months
Change in Health Care Communication Questionnaire (HCCQ)
This is a 6-question questionnaire. Responses are given on a Likert scale from Strongly Disagree to Strongly Agree. The range of scores is 1-7, the final score being the mean of all individual responses. Higher scores indicate a perception of better communication with the health care provider.
Measured: baseline to 6 months
Change in Geriatric Depression Scale - Short Form (GDS-SF-15)
This is a 15-question instrument that has a range from 0-15. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: baseline to 6 months
Change in Mini Asthma Quality of Life Questionnaire (AQOL)
This is a 15 question questionnaire. The scores range 1-7, with higher scores indicating better quality of life.
Measured: baseline to 6 months
Change in Short Form Health Survey (SF-12v2) - 12 questions. Survey responses are grouped into two scales: physical score and mental score. Higher scores indicate perception of better health.
This is a 12 question survey. Survey responses are grouped into two scales: physical score and mental score. The range of scores is 0-100, higher scores indicate perception of better health.
Measured: baseline 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 posted10 Feb 2023
- Study start13 Jun 2023
- Primary completion14 May 2024
- Study completion31 May 2024
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 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 participants along with the Primary care physicians will be enrolled (both will sign consents).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- 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
- NCT05722834
- Sponsor's protocol ID
- HUM00219528
- Acronym
- SOAR
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2023
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-regulation for Older Adults With Asthma Through Remote Education
- ClinicalTrials.gov ID
- NCT05722834
- Acronym / sponsor ID
- SOAR / HUM00219528
- Conditions
- Asthma
- Keywords
- Asthma education, Self-Regulation, Remote education, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Feb 2023 (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 research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for asthma.
The purpose of this study is to implement and evaluate an asthma self-management intervention through multiple locations in the United States that is tailored to the challenges older adults face and is based on an individual behavioral theory of change.
Eligible participants will be enrolled and participate for six weeks in the SOAR intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 participants along with the Primary care physicians will be enrolled (both will sign consents).
| Arm | Type | Receives |
|---|---|---|
| SOAR intervention | Experimental | Behavioral: SOAR interventionThe SOAR intervention will be a remote intervention that will follow a self-regulation process in which the participant first selects a specific problem to address and researches how asthma is preventing resolution of the problem, and finally identifies and develops a plan to achieve the objective. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Physician diagnosis of asthma
- Poorly controlled asthma, as evidenced by a score ≤ 19 on the Asthma Control Test
- Have a primary care provider willing to participate in the study by receiving email updates regarding the status of the participant
Key exclusion criteria (4 listed)
- Physician diagnosis of any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)
- A greater than 20 pack-year smoking history
- Lack of telephone access
- Decreased cognitive capacity such that participation in the program 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 |
|---|---|---|
| SOAR interventionThis program intervention will be over 6 weeks and participants will have two group sessions and individual sessions, all conducted by an asthma health coach over Zoom (or phone). The two Zoom group sessions will be recorded so that all the information from the conversations will be maintained and used for research purposes. Additionally, participants will keep track of asthma symptoms and complete surveys at specified time-points (the last one at 6 months after participation). Primary care physicians will be sent emails regarding the self-management goals of their patients. | Behavioural | SOAR intervention |
Primary outcome
The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers
Time frame: Day 43
A 4-item instrument to assess perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived feasibility.
Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
Time frame: Day 43
A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived acceptability.
Intervention Appropriateness Measure (IAM) for patients and providers
Time frame: Day 43
This is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean. Higher scores indicate greater perceived appropriateness.
6 secondary outcomes
Change in Asthma control will be determined with the Asthma Control Test (ACT)
Time frame: baseline to 6 months
Change in Perceived Control of Asthma Questionnaire (PCAQ)
Time frame: baseline to 6 months
Change in Health Care Communication Questionnaire (HCCQ)
Time frame: baseline to 6 months
Change in Geriatric Depression Scale - Short Form (GDS-SF-15)
Time frame: baseline to 6 months
Change in Mini Asthma Quality of Life Questionnaire (AQOL)
Time frame: baseline to 6 months
Change in Short Form Health Survey (SF-12v2) - 12 questions. Survey responses are grouped into two scales: physical score and mental score. Higher scores indicate perception of better health.
Time frame: baseline 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 1 Jul 2024.
- 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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOAR intervention in people with Asthma, run by University of Michigan at 3 sites 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers (time frame: Day 43). The study lists 3 primary outcomes in all. 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 1 Jul 2024.