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| ID | Type | Description | Link |
|---|---|---|---|
| R44HL114162 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Mayo Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Monitor plus Health Coaching | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| health coaching | Behavioral | Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Quality of Life measured at baseline (week 1) and week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Seifert, MPH | Minnesota HealthSolutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33906954 | Derived | Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27. |
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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)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data is provided for 119 participants who completed the study. | Posted | Mean | Standard Deviation | steps | Steps measured at baseline (week 1) and week 9 |
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Adverse events were monitored through the study time frame, an average of 17 weeks per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johanna Hoult | Mayo Clinic | 507-293-1989 | hoult.johanna@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2014 | Nov 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Physical Activity from ActiGraph | Mean | Standard Deviation | steps |
|
| Quality of Life Physical Summary | The Chronic Respiratory Disease Questionnaire uses 20 items in four categories to assess quality of life. Physical summary uses the dyspnea and fatigue categories. The items are assessed numerically on a 7-point modified Likert scale. Scores for each category are obtained by adding the scores for the items that make up the category and dividing by the number of items. Physical summary adds the fatigue and dyspnea scores and divides by two; hence, the range for each item, domain, and physical scale is 1 to 7. A minimally important difference is a change in score of 0.5 or more. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
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| 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. | Data is provided for 119 participants who completed the study. | Posted | Mean | Standard Deviation | units on a scale | Quality of Life measured at baseline (week 1) and week 9 |
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| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | 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. | 0 | 74 | 0 | 74 | 0 | 74 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |