Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.
Interventions
BEHAVIORALhealth coaching
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Sara Seifert
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of GOLD stage II, III, or IV COPD * current or previous smoker with at least 10 pack-years of cigarette smoking * be hospitalized for an exacerbation of COPD
Exclusion criteria
* high likelihood of being lost to follow-up or contact * inability to provide good data or follow commands * inability to do mild exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Daily Steps Between the Intervention and Control Conditions | Steps measured at baseline (week 1) and week 9 | 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. |
| Change in Physical Quality of Life Between the Intervention and Control Conditions | Quality of Life measured at baseline (week 1) and week 9 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| 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. | 74 |
| Total | 146 |
Baseline characteristics
| Characteristic | Control | Total | Activity Monitor Plus Health Coaching |
|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 9.1 | 68.9 years STANDARD_DEVIATION 8.6 | 69.4 years STANDARD_DEVIATION 8.1 |
| Physical Activity from ActiGraph | 4426.3 steps STANDARD_DEVIATION 2628.3 | 4016.1 steps STANDARD_DEVIATION 2326.7 | 3547.3 steps STANDARD_DEVIATION 1835.8 |
| Quality of Life Physical Summary | 4.2 units on a scale STANDARD_DEVIATION 1.1 | 4.2 units on a scale STANDARD_DEVIATION 1.2 | 4.3 units on a scale STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 73 Participants | 143 Participants | 70 Participants |
| Sex: Female, Male Female | 37 Participants | 75 Participants | 38 Participants |
| Sex: Female, Male Male | 37 Participants | 71 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 74 |
| other Total, other adverse events | 0 / 72 | 0 / 74 |
| serious Total, serious adverse events | 0 / 72 | 0 / 74 |
Outcome results
Primary
Change in Number of Daily Steps Between the Intervention and Control Conditions
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.
Time frame: Steps measured at baseline (week 1) and week 9
Population: Data is provided for 119 participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity Monitor Plus Health Coaching | Change in Number of Daily Steps Between the Intervention and Control Conditions | -344.8 steps | Standard Deviation 1657.7 |
| Control | Change in Number of Daily Steps Between the Intervention and Control Conditions | -975.8 steps | Standard Deviation 2596.3 |
Primary
Change in Physical Quality of Life Between the Intervention and Control Conditions
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.
Time frame: Quality of Life measured at baseline (week 1) and week 9
Population: Data is provided for 119 participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Activity Monitor Plus Health Coaching | Change in Physical Quality of Life Between the Intervention and Control Conditions | 0.2 units on a scale | Standard Deviation 1 |
| Control | Change in Physical Quality of Life Between the Intervention and Control Conditions | 0.0 units on a scale | Standard Deviation 0.7 |