Copd
Conditions
Keywords
COPD, Self-management, Lifestyle change, Patient education, Quality of life, Physical activity, Inhaler use, Caregiver support
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.
Interventions
BEHAVIORALSelf-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.
BEHAVIORALGround-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.
BEHAVIORALInhaler 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.
BEHAVIORALCaregiver 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.
BEHAVIORALSelf-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.
Sponsors
American Lung Association
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | Change from baseline at 90-day follow-up | Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COPD Symptom Burden | Change from baseline at 90-day follow-up | Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact. |
| Self-management Behaviors | Change from baseline at 90-day follow-up | Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management. |
| Hospitalization | Incidence at 90-day follow-up | Self-reported hospitalization history. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Condition #1 Education = short Walking training = on Inhaler training = on Caregiver support = on | 2 |
| Condition #2 Education = short Walking training = on Inhaler training = on Caregiver support = off | 3 |
| Condition #3 Education = short Walking training = on Inhaler training = off Caregiver support = on | 3 |
| Condition #4 Education = short Walking training = on Inhaler training = off Caregiver support = off | 2 |
| Condition #5 Education = short Walking training = off Inhaler training = on Caregiver support = on | 3 |
| Condition #6 Education = short Walking training = off Inhaler training = on Caregiver support = off | 3 |
| Condition #7 Education = short Walking training = off Inhaler training = off Caregiver support = on | 3 |
| Condition #8 Education = short Walking training = off Inhaler training = off Caregiver support = off | 3 |
| Condition #9 Education = long Walking training = on Inhaler training = on Caregiver support = on | 3 |
| Condition #10 Education = long Walking training = on Inhaler training = on Caregiver support = off | 3 |
| Condition #11 Education = long Walking training = on Inhaler training = off Caregiver support = on | 3 |
| Condition #12 Education = long Walking training = on Inhaler training = off Caregiver support = off | 3 |
| Condition #13 Education = long Walking training = off Inhaler training = on Caregiver support = on | 3 |
| Condition #14 Education = long Walking training = off Inhaler training = on Caregiver support = off | 3 |
| Condition #15 Education = long Walking training = off Inhaler training = off Caregiver support = on | 3 |
| Condition #16 Education = long Walking training = off Inhaler training = off Caregiver support = off | 3 |
| Total | 46 |
Baseline characteristics
| Characteristic | Condition #1 | Total | Condition #16 | Condition #15 | Condition #14 | Condition #13 | Condition #12 | Condition #11 | Condition #10 | Condition #9 | Condition #8 | Condition #7 | Condition #6 | Condition #5 | Condition #4 | Condition #3 | Condition #2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 13 | 67 years STANDARD_DEVIATION 10 | 74 years STANDARD_DEVIATION 7 | 74 years STANDARD_DEVIATION 1 | 71 years STANDARD_DEVIATION 9 | 74 years STANDARD_DEVIATION 4 | 64 years STANDARD_DEVIATION 8 | 70 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 14 | 61 years STANDARD_DEVIATION 27 | 65 years STANDARD_DEVIATION 5 | 65 years STANDARD_DEVIATION 8 | 67 years STANDARD_DEVIATION 1 | 67 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 7 | 63 years STANDARD_DEVIATION 2 | 58 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 45 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 13 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 30 Participants | 3 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 2 participants | 46 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 3 participants | 2 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 28 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 18 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 24 | 0 / 22 | 0 / 24 | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 6 / 22 | 10 / 24 | 9 / 22 | 7 / 24 | 6 / 23 | 10 / 23 | 7 / 23 | 9 / 23 |
| serious Total, serious adverse events | 6 / 22 | 2 / 24 | 7 / 22 | 1 / 24 | 6 / 23 | 2 / 23 | 2 / 23 | 6 / 23 |
Outcome results
Primary
Health-related Quality of Life
Measured by the Chronic Respiratory Disease Questionnaire (CRQ) dyspnea subscale score. Possible scale range is 1-7; higher scores indicate better health-related quality of life.
Time frame: Change from baseline at 90-day follow-up
Population: Please note that the Arms/ Groups in the Outcome Measures are a recombination of the Participant Flow Arms/ Groups to report results by factor.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management Education (Short) | Health-related Quality of Life | 0.6 score on a scale | Standard Deviation 1.5 |
| Self-management Education (Long) | Health-related Quality of Life | 0.7 score on a scale | Standard Deviation 1.5 |
| Ground-based Walking Training (on) | Health-related Quality of Life | 1.3 score on a scale | Standard Deviation 1.5 |
| Ground-based Walking Training (Off) | Health-related Quality of Life | 0.1 score on a scale | Standard Deviation 1.2 |
| Inhaler Training (on) | Health-related Quality of Life | 0.3 score on a scale | Standard Deviation 1.6 |
| Inhaler Training (Off) | Health-related Quality of Life | 0.9 score on a scale | Standard Deviation 1.3 |
| Caregiver Support (on) | Health-related Quality of Life | 0.7 score on a scale | Standard Deviation 1.5 |
| Caregiver Support (Off) | Health-related Quality of Life | 0.5 score on a scale | Standard Deviation 1.4 |
Secondary
COPD Symptom Burden
Measured by the COPD Assessment Test (CAT), an 8-item questionnaire measuring the global impact of dyspnea on health status. Possible score range is 0-40; higher scores indicate more severe symptom impact.
Time frame: Change from baseline at 90-day follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management Education (Short) | COPD Symptom Burden | -1.9 units on a scale | Standard Deviation 6 |
| Self-management Education (Long) | COPD Symptom Burden | -3.1 units on a scale | Standard Deviation 5 |
| Ground-based Walking Training (on) | COPD Symptom Burden | -3.9 units on a scale | Standard Deviation 4.9 |
| Ground-based Walking Training (Off) | COPD Symptom Burden | -1.5 units on a scale | Standard Deviation 5.8 |
| Inhaler Training (on) | COPD Symptom Burden | -0.4 units on a scale | Standard Deviation 4.3 |
| Inhaler Training (Off) | COPD Symptom Burden | -4.3 units on a scale | Standard Deviation 5.9 |
| Caregiver Support (on) | COPD Symptom Burden | -0.6 units on a scale | Standard Deviation 4.5 |
| Caregiver Support (Off) | COPD Symptom Burden | -4.4 units on a scale | Standard Deviation 5.9 |
Secondary
Hospitalization
Self-reported hospitalization history.
Time frame: Incidence at 90-day follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-management Education (Short) | Hospitalization | 2 Participants |
| Self-management Education (Long) | Hospitalization | 2 Participants |
| Ground-based Walking Training (on) | Hospitalization | 3 Participants |
| Ground-based Walking Training (Off) | Hospitalization | 1 Participants |
| Inhaler Training (on) | Hospitalization | 4 Participants |
| Inhaler Training (Off) | Hospitalization | 0 Participants |
| Caregiver Support (on) | Hospitalization | 1 Participants |
| Caregiver Support (Off) | Hospitalization | 3 Participants |
Secondary
Self-management Behaviors
Measured by the Patient Activation Measure (PAM-13), a 13-item questionnaire measuring patient knowledge, skill, and confidence for self-management. Items are summed to yield a raw score (possible range 13-52), which is then converted to a normalized score (possible range 0-100). Higher scores indicate better self-management.
Time frame: Change from baseline at 90-day follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-management Education (Short) | Self-management Behaviors | 3.6 score on a scale | Standard Deviation 18 |
| Self-management Education (Long) | Self-management Behaviors | 12.7 score on a scale | Standard Deviation 16.9 |
| Ground-based Walking Training (on) | Self-management Behaviors | 10.9 score on a scale | Standard Deviation 17.9 |
| Ground-based Walking Training (Off) | Self-management Behaviors | 6.2 score on a scale | Standard Deviation 18 |
| Inhaler Training (on) | Self-management Behaviors | 3.1 score on a scale | Standard Deviation 20.9 |
| Inhaler Training (Off) | Self-management Behaviors | 11.6 score on a scale | Standard Deviation 15 |
| Caregiver Support (on) | Self-management Behaviors | 8.3 score on a scale | Standard Deviation 13.9 |
| Caregiver Support (Off) | Self-management Behaviors | 8 score on a scale | Standard Deviation 21.5 |