Self-regulation for Older Adults With Asthma Through Remote Education

NCT05722834 | Completed

• 1 other identifier: HUM00219528
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

Asthma education; Self-Regulation; Remote education; Counseling

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

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

  baseline to 6 months

• Change in Perceived Control of Asthma Questionnaire (PCAQ)

  baseline to 6 months

• Change in Health Care Communication Questionnaire (HCCQ)

  baseline to 6 months

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

  baseline to 6 months

• Change in Mini Asthma Quality of Life Questionnaire (AQOL)

  baseline to 6 months

Study Arms (1)

SOAR intervention

EXPERIMENTAL

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

Interventions

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.

SOAR intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• American Lung Association: collaborator

Study Sites (3)

University of Illinois-Chicago

Chicago, Illinois, 60607, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Asthma; Self-Control

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Alan Baptist, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: 12 participants along with the Primary care physicians will be enrolled (both will sign consents).

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 10, 2023
• Study Start: June 13, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 31, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)