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Clinical Trials/NCT05722834
NCT05722834
Completed
Not Applicable

Self-regulation for Older Adults With Asthma Through Remote Education

University of Michigan3 sites in 1 country20 target enrollmentJune 13, 2023
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Michigan
Enrollment
20
Locations
3
Primary Endpoint
Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 13, 2023
End Date
May 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alan Baptist

Associate Professor of Internal Medicine

University of Michigan

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change in Mini Asthma Quality of Life Questionnaire (AQOL)(baseline to 6 months)
  • Change in Perceived Control of Asthma Questionnaire (PCAQ)(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.(baseline to 6 months)
  • Change in Asthma control will be determined with the Asthma Control Test (ACT)(baseline to 6 months)
  • Change in Geriatric Depression Scale - Short Form (GDS-SF-15)(baseline to 6 months)
  • Change in Health Care Communication Questionnaire (HCCQ)(baseline to 6 months)

Study Sites (3)

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