Clinical trial NCT05106257: Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Official title: Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Keywords: COPD
Self-management
Lifestyle change
Patient education
Quality of life
Physical activity
Inhaler use
Caregiver support
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2021-11-03
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Although self-management treatment improves quality of life among individuals with COPD, there is limited understanding of which elements of treatment are most effective. The proposed research will test the feasibility of using an engineering-inspired study design to identify effective COPD self-management treatment components. The long-term goal of this line of research is to optimize the effectiveness of COPD self-management treatment, and improve quality of life for individuals with COPD.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is an increasingly prevalent and costly chronic health condition, and is the third major cause of morbidity and mortality in the United States. Self-management treatment programs for COPD are shown to improve health-related quality of life and prevent COPD-related hospitalizations. Despite their clinical benefits, these programs are typically multi-component and time- and resource-intensive. To date, no study has been conducted to isolate the role of individual self-management treatment components in contributing to improved COPD outcomes. The proposed research will establish the feasibility of using the Multiphase Optimization Strategy (MOST) framework to optimize COPD self-management treatment delivered by the American Lung Association (ALA) Helpline. Treatment components to be evaluated include duration of self-management education, ground-based walking training, inhaler training, and caregiver support. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization. Specific aims are:

Aim 1: Design a factorial experiment and develop operational procedures. The investigators will design a factorial experiment with the same number of experimental conditions and length of follow-up as the planned optimization trial. In collaboration with the ALA COPD Helpline, the investigators will develop operational procedures (i.e., recruitment, screening, randomization, and database management) for successful implementation.

Aim 2: Establish feasibility and acceptability by pilot testing the study design. The investigators will deliver treatment to three participants per experimental condition (N=48) with good fidelity, and will remotely assess baseline, mediator, and outcome variables. The investigators will conduct qualitative interviews at end-of-treatment with 15-20 participants. Resulting values will provide estimates of recruitment and retention rates, treatment fidelity, acceptability of treatment components, and outcome measure variability to inform a subsequent, fully-powered optimization trial. The primary outcome is health-related quality of life, with secondary outcomes of COPD symptom burden, self-management behaviors, and hospitalization.

Eligibility criteria: Inclusion criteria:

Eligible participants will be males and females who are:

1. 40 years or older,
2. report a physician diagnosis of COPD,
3. use an inhaler for COPD at least once a week,
4. able to walk at least one block without assistance,
5. able to identify a caregiver, and
6. have access to a connected device (i.e., smart phone, tablet, and/ or computer).

Exclusion criteria:

1. cognitive dysfunction impairing ability to provide informed consent and follow study procedures,
2. terminal illness (i.e. less than 6 months life expectancy) that is non-COPD related,
3. living at a chronic care facility (i.e. nursing home, assisted living), or
4. inability to speak and read English.

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: Change from baseline at 90-day follow-up
Secondary outcomes:
measure: COPD Symptom Burden
timeFrame: Change from baseline at 90-day follow-up
measure: Self-management Behaviors
timeFrame: Change from baseline at 90-day follow-up
measure: Hospitalization
timeFrame: Incidence at 90-day follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Amanda R Mathew, PhD
role: PRINCIPAL_INVESTIGATOR
References: