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

March 20, 2024 updated by: Alan Baptist, University of Michigan

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois-Chicago
        • Contact:
        • Principal Investigator:
          • Lynn Gerald, PhD, MSPH
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
        • Principal Investigator:
          • Alan Baptist, MD
        • Contact:
    • Vermont
      • Burlington, Vermont, United States, 05405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOAR intervention
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.
Behavioral: SOAR 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 43
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.
Day 43
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.
Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 6 months
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.
baseline to 6 months
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.
baseline to 6 months
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.
baseline to 6 months
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.
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.
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.
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

American Lung Association

Investigators

  • Principal Investigator: Alan Baptist, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2023

Primary Completion (Actual)

December 14, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00219528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on SOAR intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe