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SOAR Intervention for Asthma (SOAR Trial)

N/A

Waitlist Available

Led By Alan Baptist, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosis of asthma

Poorly controlled asthma, as evidenced by a score ≤ 19 on the Asthma Control Test

Must not have

Decreased cognitive capacity such that participation in the program would not be possible

Physician diagnosis of any other significant cardiopulmonary disease (including chronic obstructive pulmonary disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if changing behaviors can improve asthma in older adults. Participants will take part in a 6-week intervention tailored to their needs.

Who is the study for?

This trial is for older adults with poorly controlled asthma, as shown by a score of 19 or less on the Asthma Control Test. They must have a primary care provider to participate and be able to communicate via telephone. People can't join if they've smoked heavily in the past, lack phone access, have cognitive issues that prevent participation, or have other serious heart/lung diseases.

What is being tested?

The SOAR intervention is being tested to see if it helps manage asthma in older adults through behavior change. Participants will engage with this program for six weeks across multiple U.S. locations.

What are the potential side effects?

Since the SOAR intervention involves education and self-management without medications, there are no direct medical side effects; however, participants may experience stress or frustration while adapting new behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma by a doctor.

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My asthma is not well-managed, as shown by my low test score.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My thinking or memory problems make it hard for me to participate in studies.

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I have been diagnosed with a significant heart or lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers

Intervention Appropriateness Measure (IAM) for patients and providers

The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers

Secondary study objectives

Change in Asthma control will be determined with the Asthma Control Test (ACT)

Change in Geriatric Depression Scale - Short Form (GDS-SF-15)

Change in Health Care Communication Questionnaire (HCCQ)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SOAR interventionExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SOAR intervention

2023

N/A

~20

0 / 4Eligibility criteria met