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Self-regulation for Older Adults With Asthma Through Remote Education (SOAR)

Primary Purpose

Asthma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SOAR intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma education, Self-Regulation, Remote education, Counseling

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois-ChicagoRecruiting
  • University of MichiganRecruiting
  • University of VermontRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOAR intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers
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.
Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
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
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 Outcome Measures

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

Full Information

First Posted
February 1, 2023
Last Updated
August 1, 2023
Sponsor
University of Michigan
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT05722834
Brief Title
Self-regulation for Older Adults With Asthma Through Remote Education
Acronym
SOAR
Official Title
Self-regulation for Older Adults With Asthma Through Remote Education
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Lung Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma education, Self-Regulation, Remote education, Counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
12 participants along with the Primary care physicians will be enrolled (both will sign consents).
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SOAR intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SOAR intervention
Intervention Description
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 Outcome Measure Information:
Title
The Feasibility of Intervention Measure (FIM) of the SOAR intervention for patients and providers
Description
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.
Time Frame
Day 43
Title
Acceptability of Intervention Measure (AIM) of the SOAR intervention for patients and providers
Description
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.
Time Frame
Day 43
Title
Intervention Appropriateness Measure (IAM) for patients and providers
Description
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.
Time Frame
Day 43
Secondary Outcome Measure Information:
Title
Change in Asthma control will be determined with the Asthma Control Test (ACT)
Description
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.
Time Frame
baseline to 6 months
Title
Change in Perceived Control of Asthma Questionnaire (PCAQ)
Description
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.
Time Frame
baseline to 6 months
Title
Change in Health Care Communication Questionnaire (HCCQ)
Description
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.
Time Frame
baseline to 6 months
Title
Change in Geriatric Depression Scale - Short Form (GDS-SF-15)
Description
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.
Time Frame
baseline to 6 months
Title
Change in Mini Asthma Quality of Life Questionnaire (AQOL)
Description
This is a 15 question questionnaire. The scores range 1-7, with higher scores indicating better quality of life.
Time Frame
baseline to 6 months
Title
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.
Description
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.
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Carpenter
Phone
734-232-6868
Email
lauriemc@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Gerald, PhD, MSPH
Email
lgerald@uic.edu
First Name & Middle Initial & Last Name & Degree
Lynn Gerald, PhD, MSPH
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurie Carpenter
Phone
734-232-6868
Email
lauriemc@umich.edu
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Dixon
Email
anne.dixon@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Anne Dixon

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-regulation for Older Adults With Asthma Through Remote Education

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