Clinical trial NCT05722834: Self-regulation for Older Adults With Asthma Through Remote Education
Official title: Self-regulation for Older Adults With Asthma Through Remote Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma education
Self-Regulation
Remote education
Counseling
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2023-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 12 participants along with the Primary care physicians will be enrolled (both will sign consents).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers
timeFrame: Day 43
measure: Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
timeFrame: Day 43
measure: Intervention Appropriateness Measure (IAM) for patients and providers
timeFrame: Day 43
Secondary outcomes:
measure: Change in Asthma control will be determined with the Asthma Control Test (ACT)
timeFrame: baseline to 6 months
measure: Change in Perceived Control of Asthma Questionnaire (PCAQ)
timeFrame: baseline to 6 months
measure: Change in Health Care Communication Questionnaire (HCCQ)
timeFrame: baseline to 6 months
measure: Change in Geriatric Depression Scale - Short Form (GDS-SF-15)
timeFrame: baseline to 6 months
measure: Change in Mini Asthma Quality of Life Questionnaire (AQOL)
timeFrame: baseline to 6 months
measure: 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.
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois-Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Michigan
name: Alan Baptist, MD
role: PRINCIPAL_INVESTIGATOR
References: