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Trial Outcomes & Findings for Comprehensive Self-management Support for COPD Patients (NCT NCT04533412)

NCT ID: NCT04533412

Last Updated: 2023-09-28

Results Overview

The COPD Assessment Test (CAT) is a validated measure designed to measure the impact of COPD on a person's life, and how this changes over time. Full range from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2023-09-28

Participant Flow

Recruitment Site for Phase 1: Icahn School of Medicine at Mount Sinai \& Northwestern University, Phase 2 Site: Icahn School of Medicine at Mount Sinai

Participant milestones

Participant milestones
Measure
Targeted Self-management Barrier Support
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Overall Study
STARTED
30
29
Overall Study
COMPLETED
28
24
Overall Study
NOT COMPLETED
2
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Targeted Self-management Barrier Support
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Overall Study
Withdrawal by Subject
1
1
Overall Study
Lost to Follow-up
1
4

Baseline Characteristics

Comprehensive Self-management Support for COPD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Targeted Self-management Barrier Support
n=30 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=29 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Total
n=59 Participants
Total of all reporting groups
Age, Continuous
64.2 years
STANDARD_DEVIATION 7.7 • n=99 Participants
64.0 years
STANDARD_DEVIATION 8.4 • n=107 Participants
64.1 years
STANDARD_DEVIATION 8.0 • n=206 Participants
Sex: Female, Male
Female
19 Participants
n=99 Participants
18 Participants
n=107 Participants
37 Participants
n=206 Participants
Sex: Female, Male
Male
11 Participants
n=99 Participants
11 Participants
n=107 Participants
22 Participants
n=206 Participants
Race/Ethnicity, Customized
White, non-Hispanic
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Race/Ethnicity, Customized
Black, non-Hispanic
17 Participants
n=99 Participants
11 Participants
n=107 Participants
28 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic
11 Participants
n=99 Participants
15 Participants
n=107 Participants
26 Participants
n=206 Participants
Education
<High school
10 Participants
n=99 Participants
8 Participants
n=107 Participants
18 Participants
n=206 Participants
Education
High school graduate
7 Participants
n=99 Participants
9 Participants
n=107 Participants
16 Participants
n=206 Participants
Education
Some college
9 Participants
n=99 Participants
10 Participants
n=107 Participants
19 Participants
n=206 Participants
Education
College graduate or higher degree
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Education
Missing information
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Number of participants with monthly household income ≤$3000
26 Participants
n=99 Participants
24 Participants
n=107 Participants
50 Participants
n=206 Participants
Married/partnered
2 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
Number of participants with Medicaid insurance
19 Participants
n=99 Participants
19 Participants
n=107 Participants
38 Participants
n=206 Participants
Number of participants with marginal or inadequate Health Literacy
16 Participants
n=99 Participants
14 Participants
n=107 Participants
30 Participants
n=206 Participants
Social Provisional Scale: The EPS-10 Items
32.7 units on a scale
STANDARD_DEVIATION 5.2 • n=99 Participants
32.4 units on a scale
STANDARD_DEVIATION 4.0 • n=107 Participants
32.6 units on a scale
STANDARD_DEVIATION 4.6 • n=206 Participants
Number of participants with poor-fair physical/mental general health on PROMIS Global Health (v 1.2)
9 Participants
n=99 Participants
7 Participants
n=107 Participants
16 Participants
n=206 Participants
Charlson Comorbidity Index
6.0 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
5.6 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
5.8 units on a scale
STANDARD_DEVIATION 2.7 • n=206 Participants
Modified Activities of Daily Living (ADL) total score
0.7 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
0.5 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
0.6 units on a scale
STANDARD_DEVIATION 1.2 • n=206 Participants
Lawton -Brody Instrumental Activities of Daily Living Scale (IADL) total score
2.3 units on a scale
STANDARD_DEVIATION 2.7 • n=99 Participants
2.6 units on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
2.5 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
Number of participants who scored between 11-21 on the HADS anxiety subscale
8 Participants
n=99 Participants
5 Participants
n=107 Participants
13 Participants
n=206 Participants
Number of participants who scored between 11-21 on the depression subscale of the HADS
3 Participants
n=99 Participants
4 Participants
n=107 Participants
7 Participants
n=206 Participants
Number of participants with for ≥mild impairment on the Trail Making Test B
6 Participants
n=99 Participants
5 Participants
n=107 Participants
11 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: 6 month data provide for those who completed the 6 month visit.

The COPD Assessment Test (CAT) is a validated measure designed to measure the impact of COPD on a person's life, and how this changes over time. Full range from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=30 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=29 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
COPD Assessment Test (CAT)
Baseline
22.0 score on a scale
Standard Deviation 8.6
21.9 score on a scale
Standard Deviation 8.3
COPD Assessment Test (CAT)
6 months
21.5 score on a scale
Standard Deviation 9.6
22.7 score on a scale
Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Participants not included if not on controller medication or were not taking their prescribed controller medication/not filling doctor prescriptions and hence did not complete MARS.

The MARS is a validated measure to assess COPD medication adherence. The MARS assess asthma beliefs about asthma medication adherence. The MARS is a 10-item instrument, full range from 0-10, higher score indicates higher likelihood of medication adherence. Adherence was defined as a score ≥4.5.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=29 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=27 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Number of Participants With Medication Adherence Report Scale (MARS) Score ≥4.5
6 months
14 Participants
10 Participants
Number of Participants With Medication Adherence Report Scale (MARS) Score ≥4.5
Baseline
13 Participants
13 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Reasons for missed visits include 6 month phone interview instead of in person visit, participants not feeling well or wheelchair bound.

The six minute walking test (6MWT), developed by the American Thoracic Society, is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes. Participants walked back and forth in the hallway with aim to walk as far as possible in 6 minutes. Participants were allowed to slow down, to stop, and to rest as necessary. They may stand and rest but resume walking as soon as they were able.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=26 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=25 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Exercise Tolerance - 6 Minute Walk Test
Baseline
244.3 meters
Standard Deviation 92.4
288.3 meters
Standard Deviation 101.2
Exercise Tolerance - 6 Minute Walk Test
6 months
266.9 meters
Standard Deviation 76.9
291.0 meters
Standard Deviation 68.8

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Missing data because there is branching logic in instrument, wherein, if the previous question asking whether an activity was done is answered "no", the following question will not be asked to the participants.

The PAAQ captures behavior in the seven days before the visit. Questions pertain to total time spent doing moderate to vigorous-intensity physical activity (MVPA) in three domains: transportation, leisure time and other (includes work, home and volunteering), and how much time was dedicated to vigorous activity (compared with total MVPA). Respondents are asked to report activities that lasted at least 10 consecutive minutes. Once completed, a total amount of time spent doing MVPA in the last 7 days was calculated. Cut off in terms of the specific definition of physical activity in the Guidelines-\>accumulating at least 150 minutes of MVPA a week in bouts of at least 10 minutes is considered adequate.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=20 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=21 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Physical Activity Adult Questionnaire (PAAQ)
Baseline
214 minutes
Standard Deviation 190
231 minutes
Standard Deviation 294
Physical Activity Adult Questionnaire (PAAQ)
6 months
262 minutes
Standard Deviation 271
234 minutes
Standard Deviation 402

SECONDARY outcome

Timeframe: Baseline and 6 months

Number of participants with hospitalizations for COPD exacerbations or any respiratory issue in the prior 6 months.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=30 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=29 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Number of Participants With Hospitalizations
Baseline
15 Participants
14 Participants
Number of Participants With Hospitalizations
6 months
10 Participants
12 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Number of participants with Emergency Dept (ED) for COPD exacerbations or any respiratory issue in the prior 6 months.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=30 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=29 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Number of Participants With ED Visits
Baseline
15 Participants
19 Participants
Number of Participants With ED Visits
6 months
13 Participants
13 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Data for participants that have controller device data

Medication adherence was also measured using electronic monitoring devices, the Doser CT (Meditrack, Hudson, MA) for metered dose inhalers and the Smartdisk (Nexus6, Franklin, OH) for dry powder inhalers. Patients used the devices over a 4-week period of observation. Adherence was defined as use of ≥80% of doses prescribed.

Outcome measures

Outcome measures
Measure
Targeted Self-management Barrier Support
n=13 Participants
Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers Self-management barrier support: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
Guided COPD Education
n=11 Participants
Control group - Guided COPD education with a COPD educator Basic COPD Education: The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.
Number of Participants With Controller Medication Adherence
Baseline
3 Participants
3 Participants
Number of Participants With Controller Medication Adherence
6 months
5 Participants
0 Participants

Adverse Events

Targeted Self-management Barrier Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Guided COPD Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alex D. Federman, MD, MPH

Icahn School of Medicine at Mount Sinai

Phone: (212) 824-7565

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place