Self-regulation for Older Adults With Asthma Through Remote Education

Study 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.

Official Title
-----------------
Self-regulation for Older Adults With Asthma Through Remote Education

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: SOAR intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 12 participants along with the Primary care physicians will be enrolled (both will sign consents).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOAR intervention<br>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<br>* 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.<br>|

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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma education, Self-Regulation, Remote education, Counseling