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| ID | Type | Description | Link |
|---|---|---|---|
| 1K24HL138150-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Coaching | Experimental | Participants in this group will receive health coaching calls |
|
| Control group | Active Comparator | Participants in this group will receive 6 educational guides |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching Calls | Behavioral | Participants in this group will receive 12 weekly health coaching calls |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score | The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea. | Baseline, 3 months |
| Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score | The CRQ-Fatigue is a 4-item questionnaire that assesses fatigue on a Likert scale from 1 - 7. Higher scores indicate less severity of fatigue. | Baseline, 3 months |
| Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score | The CRQ-Mastery is a 4-item questionnaire that assesses mastery on a Likert scale from 1 - 7. Higher scores indicate a higher level of mastering the ability to deal with the symptoms of the disease. | Baseline, 3 months |
| Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score | The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 - 7. Higher scores indicate less severity of emotions. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Physical Activity | Mean change in the number of steps per day | Baseline,3 months |
| Change in Self Management | Self-Management Ability Scale-30 item questionnaire measuring ability and function. Total score range is 0-100, higher score indicated better ability and function. |
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Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath.
Exclusion: terminal illness, inability to communicate by phone
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| Name | Affiliation | Role |
|---|---|---|
| Roberto P Benzo | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants in this group received 6 educational guides and 6 calls Control: Participants in this group received 6 educational guides and 6 calls to remind them to read the educational guides |
| FG001 | Health Coaching | Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants in this group received 6 educational guides and 6 calls Control: Participants in this group received 6 educational guides and 6 calls to remind them to read the educational guides |
| BG001 | Health Coaching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age and Sex are unknown for one participant in each arm |
| 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 Chronic Respiratory Questionnaire (CRQ) Dyspnea Score | The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
Adverse Events were collected from baseline to end of study, approximately 1 year.
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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 | Control Group | Participants in this group received 6 educational guides and 6 calls Control: Participants in this group received 6 educational guides and 6 calls to remind them to read the educational guides |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto P. Benzo, M.D. | Mayo Clinic | 507-284-0561 | Benzo.Roberto@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 | Apr 14, 2021 | May 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Randomized Control wait design
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It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.
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| Control | Behavioral | Participants in this group will receive 6 educational guides |
|
| Baseline, 3 months |
| Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning | The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Presence of Meaning subscale score = subtract the rating for item #9 from 8, then add to the ratings for items 1, 4, 5, and 6. Total Presence of Meaning Scores range between 5 and 35. Higher scores indicate more fullness of meaning a person feels in their life. | Baseline, 3 months |
| Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning | The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Search for Meaning subscale score = add together the ratings for items 2, 3, 7, 8, and 10. Total Search for Meaning scores range between 5 and 35. Higher scores indicate more engaged and motivated a person feels to understand and find meaning in their life | Baseline, 3 months |
| Change in Depression | The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. | Baseline, 3 months |
| Change in Anxiety | The General Anxiety Disorder 2-item (GAD 2) scale assess severity of generalized anxiety disorder. Total scores range from 0-6, a higher score indicates greater anxiety. | Baseline,3 months |
Participants in this group received health coaching calls
Health Coaching Calls: Participants in this group received 12 weekly health coaching calls
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Age and Sex are unknown for one participant in each arm | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score | The CRQ-Fatigue is a 4-item questionnaire that assesses fatigue on a Likert scale from 1 - 7. Higher scores indicate less severity of fatigue. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Primary | Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score | The CRQ-Mastery is a 4-item questionnaire that assesses mastery on a Likert scale from 1 - 7. Higher scores indicate a higher level of mastering the ability to deal with the symptoms of the disease. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Primary | Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score | The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 - 7. Higher scores indicate less severity of emotions. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Daily Physical Activity | Mean change in the number of steps per day | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | steps per day | Baseline,3 months |
|
|
|
| Secondary | Change in Self Management | Self-Management Ability Scale-30 item questionnaire measuring ability and function. Total score range is 0-100, higher score indicated better ability and function. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning | The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Presence of Meaning subscale score = subtract the rating for item #9 from 8, then add to the ratings for items 1, 4, 5, and 6. Total Presence of Meaning Scores range between 5 and 35. Higher scores indicate more fullness of meaning a person feels in their life. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning | The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Search for Meaning subscale score = add together the ratings for items 2, 3, 7, 8, and 10. Total Search for Meaning scores range between 5 and 35. Higher scores indicate more engaged and motivated a person feels to understand and find meaning in their life | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Depression | The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Anxiety | The General Anxiety Disorder 2-item (GAD 2) scale assess severity of generalized anxiety disorder. Total scores range from 0-6, a higher score indicates greater anxiety. | Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline,3 months |
|
|
|
| 3 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Health Coaching | Participants in this group received health coaching calls Health Coaching Calls: Participants in this group received 12 weekly health coaching calls | 2 | 30 | 0 | 30 | 0 | 30 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|