Trial Outcomes & Findings for Home-Based Health Management of COPD Patients (NCT NCT02557178)
NCT ID: NCT02557178
Last Updated: 2021-02-24
Results Overview
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
COMPLETED
NA
154 participants
Steps measured at baseline (week 1) and week 9
2021-02-24
Participant Flow
2 controls off study before completing baseline forms or phone calls (1 withdrew and 1 lost to follow up) 6 intervention participants off study before completing baseline forms or phone calls (5 withdrew and 1 lost to follow up)
Participant milestones
| Measure |
Activity Monitor Plus Health Coaching
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
|
Control
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
COMPLETED
|
56
|
63
|
|
Overall Study
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home-Based Health Management of COPD Patients
Baseline characteristics by cohort
| Measure |
Activity Monitor Plus Health Coaching
n=72 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
|
Control
n=74 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
68.5 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
68.9 years
STANDARD_DEVIATION 8.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Physical Activity from ActiGraph
|
3547.3 steps
STANDARD_DEVIATION 1835.8 • n=93 Participants
|
4426.3 steps
STANDARD_DEVIATION 2628.3 • n=4 Participants
|
4016.1 steps
STANDARD_DEVIATION 2326.7 • n=27 Participants
|
|
Quality of Life Physical Summary
|
4.3 units on a scale
STANDARD_DEVIATION 1.2 • n=93 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.1 • n=4 Participants
|
4.2 units on a scale
STANDARD_DEVIATION 1.2 • n=27 Participants
|
PRIMARY outcome
Timeframe: Steps measured at baseline (week 1) and week 9Population: Data is provided for 119 participants who completed the study.
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Outcome measures
| Measure |
Activity Monitor Plus Health Coaching
n=56 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
|
Control
n=63 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
|
|---|---|---|
|
Change in Number of Daily Steps Between the Intervention and Control Conditions
|
-344.8 steps
Standard Deviation 1657.7
|
-975.8 steps
Standard Deviation 2596.3
|
PRIMARY outcome
Timeframe: Quality of Life measured at baseline (week 1) and week 9Population: Data is provided for 119 participants who completed the study.
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.
Outcome measures
| Measure |
Activity Monitor Plus Health Coaching
n=56 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
health coaching: Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
|
Control
n=63 Participants
Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.
|
|---|---|---|
|
Change in Physical Quality of Life Between the Intervention and Control Conditions
|
0.2 units on a scale
Standard Deviation 1.0
|
0.0 units on a scale
Standard Deviation 0.7
|
Adverse Events
Activity Monitor Plus Health Coaching
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place