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OpenTrials
Completed

NCT Number: NCT05722834

Self-regulation for Older Adults With Asthma Through Remote Education

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.

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Key information

Conditions

Asthma Behavior Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Self-Control Social Behavior

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois-Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOAR intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

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

    Time frame: baseline to 6 months

    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.

  2. Change in Perceived Control of Asthma Questionnaire (PCAQ)

    Time frame: baseline to 6 months

    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.

  3. Change in Health Care Communication Questionnaire (HCCQ)

    Time frame: baseline to 6 months

    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.

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

    Time frame: baseline to 6 months

    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.

  5. Change in Mini Asthma Quality of Life Questionnaire (AQOL)

    Time frame: baseline to 6 months

    This is a 15 question questionnaire. The scores range 1-7, with higher scores indicating better quality of life.

  6. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Lung Association

Registry information

Acronym: SOAR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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