Optimizing Self-management COPD Treatment Through the American Lung Association Helpline

Copd Clinical Trial

Official title:

Optimizing Self-management COPD Treatment Through the American Lung Association Helpline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05106257
• Other study ID #: 20050506
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Copd

Intervention

Behavioral:
• Self-management education (short)
The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The short condition consists of two calls (30-45 minutes each) to introduce patient education topics and refer to the booklet for further information.
• Ground-based walking training
Participants randomized to this condition will be mailed a pedometer (3DFitBud Simple Step Counter) and instructed on its use to establish baseline steps/ day for 7 days. They will then receive a booklet with instructions to establish a walking program and three brief (10-15 minute), bi-weekly calls from a trained staff member to review step count values and engage in setting personal activity goals over the course of 6 weeks, following established exercise guidelines for individuals with COPD.
• Inhaler training
Participants randomized to this condition will receive two sessions of inhaler technique education using a virtual teach-to-goal (TTG) method in which individuals are observed using their inhaler, provided feedback, and then observed again.
• Caregiver support
Participants randomized to this condition will identify an informal caregiver who is involved in their healthcare (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit, a comprehensive informational resource to support the care of the person living with COPD. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member. The structured content of these sessions will include providing an overview of toolkit content, identifying goals for sections(s) to review and incorporate into caregiving activities, and addressing any questions.
• Self-management education (long)
The self-management education condition is based on the Living Well with COPD program. The program consists of a mailed booklet and structured phone counseling delivered by certified COPD educators. Topics include disease information, breathing retraining, action planning, medication use, energy conservation, and following good health habits. The long condition consists of five, weekly calls (30-45 minutes each) following a structured curriculum of patient education topics.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	Measured by the Chronic Respiratory Disease Questionnaire (CRQ), a 20-item questionnaire yielding a total score and subscale scores for mastery, fatigue, emotional functioning, and dyspnea. The total score ranges from 20-140, with 10 points considered to be a minimal clinically important difference.	Change from baseline at 90-day follow-up
Secondary	COPD symptom burden	Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status.	Change from baseline at 90-day follow-up
Secondary	Self-management behaviors	Measured by the Patient Activation Measure (PAM-13), 9 a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management.	Change from baseline at 90-day follow-up
Secondary	Hospitalization	Self-reported hospitalization history.	Incidence at 90-day follow-up