An interventional study of health coaching in Chronic Obstructive Pulmonary Disease, sponsored by Sara Seifert. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by Sara Seifert · Not applicable, Interventional, and Supportive care
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 154 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →This is the only study on the registry with Sara Seifert as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: 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.
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
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
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
| Milestone | Activity Monitor Plus Health Coaching | Control |
|---|---|---|
| Started | 72 | 74 |
| Completed | 56 | 63 |
| Not completed | 16 | 11 |
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.
| steps | Activity Monitor Plus Health Coaching | Control |
|---|---|---|
| Change in Number of Daily Steps Between the Intervention and Control Conditions | -344.8 ± 1657.7 | -975.8 ± 2596.3 |
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.
| units on a scale | Activity Monitor Plus Health Coaching | Control |
|---|---|---|
| Change in Physical Quality of Life Between the Intervention and Control Conditions | 0.2 ± 1.0 | 0.0 ± 0.7 |
Collected over Adverse events were monitored through the study time frame, an average of 17 weeks per participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Activity Monitor Plus Health Coaching | 0/72 (0%) | 0/72 (0%) | 0/72 (0%) |
| Control | 0/74 (0%) | 0/74 (0%) | 0/74 (0%) |
| Age, Continuous(years) | Activity Monitor Plus Health Coaching | Control | Total |
|---|---|---|---|
| Mean | 69.4 ± 8.1 | 68.5 ± 9.1 | 68.9 ± 8.6 |
| Sex: Female, Male(Participants) | Activity Monitor Plus Health Coaching | Control | Total |
|---|---|---|---|
| Female | 38 | 37 | 75 |
| Male | 34 | 37 | 71 |
| Race (NIH/OMB)(Participants) | Activity Monitor Plus Health Coaching | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 70 | 73 | 143 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Physical Activity from ActiGraph(steps) | Activity Monitor Plus Health Coaching | Control | Total |
|---|---|---|---|
| Mean | 3547.3 ± 1835.8 | 4426.3 ± 2628.3 | 4016.1 ± 2326.7 |
| Quality of Life Physical Summary(units on a scale) | Activity Monitor Plus Health Coaching | Control | Total |
|---|---|---|---|
| Mean | 4.3 ± 1.2 | 4.2 ± 1.1 | 4.2 ± 1.2 |
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