Trial Outcomes & Findings for Optimizing Self-management COPD Treatment Through the American Lung Association Helpline (NCT NCT05106257)
NCT ID: NCT05106257
Last Updated: 2025-02-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Change from baseline at 90-day follow-up
Results posted on
2025-02-20
Participant Flow
Participant milestones
| Measure |
Condition #1
Education = short Walking training = on Inhaler training = on Caregiver support = on
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. The short condition consists of two calls (30-45 minutes each).
Ground-based walking training: Participants randomized to this condition will be mailed a pedometer 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.
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 (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Condition #2
Education = short Walking training = on Inhaler training = on Caregiver support = off
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.
|
Condition #3
Education = short Walking training = on Inhaler training = off Caregiver support = on
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. The short condition consists of two calls (30-45 minutes each).
Ground-based walking training: Participants randomized to this condition will be mailed a pedometer 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.
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Condition #4
Education = short Walking training = on Inhaler training = off Caregiver support = off
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.
|
Condition #5
Education = short Walking training = off Inhaler training = on Caregiver support = on
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. The short condition consists of two calls (30-45 minutes each).
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 (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Condition #6
Education = short Walking training = off Inhaler training = on Caregiver support = off
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.
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.
|
Condition #7
Education = short Walking training = off Inhaler training = off Caregiver support = on
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.
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.
|
Condition #8
Education = short Walking training = off Inhaler training = off Caregiver support = off
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.
|
Condition #9
Education = long Walking training = on Inhaler training = on Caregiver support = on
Ground-based walking training: Participants randomized to this condition will be mailed a pedometer 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.
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 (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
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. The long condition consists of five, weekly calls (30-45 minutes each).
|
Condition #10
Education = long Walking training = on Inhaler training = on Caregiver support = off
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.
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.
|
Condition #11
Education = long Walking training = on Inhaler training = off Caregiver support = on
Ground-based walking training: Participants randomized to this condition will be mailed a pedometer 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.
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
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. The long condition consists of five, weekly calls (30-45 minutes each).
|
Condition #12
Education = long Walking training = on Inhaler training = off Caregiver support = off
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.
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.
|
Condition #13
Education = long Walking training = off Inhaler training = on Caregiver support = on
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 (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
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. The long condition consists of five, weekly calls (30-45 minutes each).
|
Condition #14
Education = long Walking training = off Inhaler training = on Caregiver support = off
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.
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.
|
Condition #15
Education = long Walking training = off Inhaler training = off Caregiver support = on
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.
|
Condition #16
Education = long Walking training = off Inhaler training = off Caregiver support = off
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
2
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
2
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimizing Self-management COPD Treatment Through the American Lung Association Helpline
Baseline characteristics by cohort
| Measure |
Condition #1
n=2 Participants
Education = short Walking training = on Inhaler training = on Caregiver support = on
|
Condition #2
n=3 Participants
Education = short Walking training = on Inhaler training = on Caregiver support = off
|
Condition #3
n=3 Participants
Education = short Walking training = on Inhaler training = off Caregiver support = on
|
Condition #4
n=2 Participants
Education = short Walking training = on Inhaler training = off Caregiver support = off
|
Condition #5
n=3 Participants
Education = short Walking training = off Inhaler training = on Caregiver support = on
|
Condition #6
n=3 Participants
Education = short Walking training = off Inhaler training = on Caregiver support = off
|
Condition #7
n=3 Participants
Education = short Walking training = off Inhaler training = off Caregiver support = on
|
Condition #8
n=3 Participants
Education = short Walking training = off Inhaler training = off Caregiver support = off
|
Condition #9
n=3 Participants
Education = long Walking training = on Inhaler training = on Caregiver support = on
|
Condition #10
n=3 Participants
Education = long Walking training = on Inhaler training = on Caregiver support = off
|
Condition #11
n=3 Participants
Education = long Walking training = on Inhaler training = off Caregiver support = on
|
Condition #12
n=3 Participants
Education = long Walking training = on Inhaler training = off Caregiver support = off
|
Condition #13
n=3 Participants
Education = long Walking training = off Inhaler training = on Caregiver support = on
|
Condition #14
n=3 Participants
Education = long Walking training = off Inhaler training = on Caregiver support = off
|
Condition #15
n=3 Participants
Education = long Walking training = off Inhaler training = off Caregiver support = on
|
Condition #16
n=3 Participants
Education = long Walking training = off Inhaler training = off Caregiver support = off
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 13 • n=5 Participants
|
58 years
STANDARD_DEVIATION 11 • n=7 Participants
|
63 years
STANDARD_DEVIATION 2 • n=5 Participants
|
66 years
STANDARD_DEVIATION 7 • n=4 Participants
|
67 years
STANDARD_DEVIATION 11 • n=21 Participants
|
67 years
STANDARD_DEVIATION 1 • n=8 Participants
|
65 years
STANDARD_DEVIATION 8 • n=8 Participants
|
65 years
STANDARD_DEVIATION 5 • n=24 Participants
|
61 years
STANDARD_DEVIATION 27 • n=42 Participants
|
63 years
STANDARD_DEVIATION 14 • n=42 Participants
|
70 years
STANDARD_DEVIATION 9 • n=42 Participants
|
64 years
STANDARD_DEVIATION 8 • n=42 Participants
|
74 years
STANDARD_DEVIATION 4 • n=36 Participants
|
71 years
STANDARD_DEVIATION 9 • n=36 Participants
|
74 years
STANDARD_DEVIATION 1 • n=24 Participants
|
74 years
STANDARD_DEVIATION 7 • n=135 Participants
|
67 years
STANDARD_DEVIATION 10 • n=136 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
28 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
18 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
45 Participants
n=136 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
13 Participants
n=136 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
30 Participants
n=136 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
3 participants
n=42 Participants
|
3 participants
n=36 Participants
|
3 participants
n=36 Participants
|
3 participants
n=24 Participants
|
3 participants
n=135 Participants
|
46 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at 90-day follow-upPopulation: Please note that the Arms/ Groups in the Outcome Measures are a recombination of the Participant Flow Arms/ Groups to report results by factor.
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.
Outcome measures
| Measure |
Self-management Education (Short)
n=22 Participants
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.
|
Self-management Education (Long)
n=24 Participants
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.
|
Ground-based Walking Training (on)
n=22 Participants
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.
|
Ground-based Walking Training (Off)
n=24 Participants
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=23 Participants
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.
|
Inhaler Training (Off)
n=23 Participants
Not randomized to receive inhaler training
|
Caregiver Support (on)
n=23 Participants
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=23 Participants
Not randomized to receive caregiver support
|
|---|---|---|---|---|---|---|---|---|
|
Health-related Quality of Life
|
0.6 score on a scale
Standard Deviation 1.5
|
0.7 score on a scale
Standard Deviation 1.5
|
1.3 score on a scale
Standard Deviation 1.5
|
0.1 score on a scale
Standard Deviation 1.2
|
0.3 score on a scale
Standard Deviation 1.6
|
0.9 score on a scale
Standard Deviation 1.3
|
0.7 score on a scale
Standard Deviation 1.5
|
0.5 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Change from baseline at 90-day follow-upMeasured 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.
Outcome measures
| Measure |
Self-management Education (Short)
n=19 Participants
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.
|
Self-management Education (Long)
n=18 Participants
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.
|
Ground-based Walking Training (on)
n=15 Participants
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.
|
Ground-based Walking Training (Off)
n=22 Participants
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=17 Participants
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.
|
Inhaler Training (Off)
n=20 Participants
Not randomized to receive inhaler training
|
Caregiver Support (on)
n=19 Participants
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=18 Participants
Not randomized to receive caregiver support
|
|---|---|---|---|---|---|---|---|---|
|
COPD Symptom Burden
|
-1.9 units on a scale
Standard Deviation 6
|
-3.1 units on a scale
Standard Deviation 5
|
-3.9 units on a scale
Standard Deviation 4.9
|
-1.5 units on a scale
Standard Deviation 5.8
|
-0.4 units on a scale
Standard Deviation 4.3
|
-4.3 units on a scale
Standard Deviation 5.9
|
-0.6 units on a scale
Standard Deviation 4.5
|
-4.4 units on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Change from baseline at 90-day follow-upMeasured 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.
Outcome measures
| Measure |
Self-management Education (Short)
n=16 Participants
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.
|
Self-management Education (Long)
n=16 Participants
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.
|
Ground-based Walking Training (on)
n=13 Participants
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.
|
Ground-based Walking Training (Off)
n=19 Participants
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=13 Participants
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.
|
Inhaler Training (Off)
n=19 Participants
Not randomized to receive inhaler training
|
Caregiver Support (on)
n=16 Participants
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=16 Participants
Not randomized to receive caregiver support
|
|---|---|---|---|---|---|---|---|---|
|
Self-management Behaviors
|
3.6 score on a scale
Standard Deviation 18
|
12.7 score on a scale
Standard Deviation 16.9
|
10.9 score on a scale
Standard Deviation 17.9
|
6.2 score on a scale
Standard Deviation 18
|
3.1 score on a scale
Standard Deviation 20.9
|
11.6 score on a scale
Standard Deviation 15
|
8.3 score on a scale
Standard Deviation 13.9
|
8 score on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Incidence at 90-day follow-upSelf-reported hospitalization history.
Outcome measures
| Measure |
Self-management Education (Short)
n=22 Participants
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.
|
Self-management Education (Long)
n=24 Participants
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.
|
Ground-based Walking Training (on)
n=22 Participants
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.
|
Ground-based Walking Training (Off)
n=24 Participants
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=23 Participants
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.
|
Inhaler Training (Off)
n=23 Participants
Not randomized to receive inhaler training
|
Caregiver Support (on)
n=23 Participants
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=23 Participants
Not randomized to receive caregiver support
|
|---|---|---|---|---|---|---|---|---|
|
Hospitalization
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Self-management Education (Short)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Self-management Education (Long)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Ground-based Walking Training (on)
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Ground-based Walking Training (Off)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Inhaler Training (on)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Inhaler Training (Off)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Caregiver Support (on)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Caregiver Support (Off)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Self-management Education (Short)
n=22 participants at risk
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.
|
Self-management Education (Long)
n=24 participants at risk
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.
|
Ground-based Walking Training (on)
n=22 participants at risk
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.
|
Ground-based Walking Training (Off)
n=24 participants at risk
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=23 participants at risk
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.
|
Inhaler Training (Off)
n=23 participants at risk
Not randomized to receive inhaler training.
|
Caregiver Support (on)
n=23 participants at risk
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=23 participants at risk
Not randomized to receive caregiver support.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation/ hospitalization
|
27.3%
6/22 • Number of events 6 • 3 months
|
8.3%
2/24 • Number of events 2 • 3 months
|
31.8%
7/22 • Number of events 7 • 3 months
|
4.2%
1/24 • Number of events 1 • 3 months
|
26.1%
6/23 • Number of events 6 • 3 months
|
8.7%
2/23 • Number of events 2 • 3 months
|
8.7%
2/23 • Number of events 2 • 3 months
|
26.1%
6/23 • Number of events 6 • 3 months
|
Other adverse events
| Measure |
Self-management Education (Short)
n=22 participants at risk
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.
|
Self-management Education (Long)
n=24 participants at risk
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.
|
Ground-based Walking Training (on)
n=22 participants at risk
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.
|
Ground-based Walking Training (Off)
n=24 participants at risk
Not randomized to receive ground-based walking training.
|
Inhaler Training (on)
n=23 participants at risk
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.
|
Inhaler Training (Off)
n=23 participants at risk
Not randomized to receive inhaler training.
|
Caregiver Support (on)
n=23 participants at risk
Caregiver support: Participants randomized to this condition will identify an informal caregiver (i.e., spouse, family member, or friend), who will receive a mailed copy of the Respiratory Health Association's COPD Caregiver's Toolkit. Caregivers will receive two brief (10-15 minute) check-in calls from a trained staff member.
|
Caregiver Support (Off)
n=23 participants at risk
Not randomized to receive caregiver support.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Symptoms requiring immediate medical attention
|
27.3%
6/22 • Number of events 6 • 3 months
|
41.7%
10/24 • Number of events 10 • 3 months
|
40.9%
9/22 • Number of events 9 • 3 months
|
29.2%
7/24 • Number of events 7 • 3 months
|
26.1%
6/23 • Number of events 6 • 3 months
|
43.5%
10/23 • Number of events 10 • 3 months
|
30.4%
7/23 • Number of events 7 • 3 months
|
39.1%
9/23 • Number of events 9 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place