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Self-regulation for Older Adults With Asthma Through Remote Education

Self-regulation for Older Adults With Asthma Through Remote Education

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05722834
Acronym
SOAR
Enrollment
20
Registered
2023-02-10
Start date
2023-06-13
Completion date
2024-05-31
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma education, Self-Regulation, Remote education, Counseling

Brief 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 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.

Interventions

BEHAVIORALSOAR intervention

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.

Sponsors

American Lung Association
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

12 participants along with the Primary care physicians will be enrolled (both will sign consents).

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providersDay 43A 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 providersDay 43A 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 providersDay 43This 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.

Secondary

MeasureTime frameDescription
Change in Geriatric Depression Scale - Short Form (GDS-SF-15)baseline to 6 monthsThis 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.
Change in Asthma control will be determined with the Asthma Control Test (ACT)baseline to 6 monthsAsthma 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.
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.baseline to 6 monthsThis 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.
Change in Mini Asthma Quality of Life Questionnaire (AQOL)baseline to 6 monthsThis is a 15 question questionnaire. The scores range 1-7, with higher scores indicating better quality of life.
Change in Perceived Control of Asthma Questionnaire (PCAQ)baseline to 6 monthsThis 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.
Change in Health Care Communication Questionnaire (HCCQ)baseline to 6 monthsThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026