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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months
Health coaching is a promising model for improving evidence-based care for patients with COPD which had not been evaluated at the time the current study began in 2014. Health coaching by health workers or peers trained as coaches, has emerged as an effective model to improve these management domains for children with asthma and adults with diabetes, and hypertension receiving care in urban safety-net clinics. The role of the health coach includes many of the activities also provided by patient navigators, patient educators, and community health workers. Health coaching is a patient-centered model that recognizes that that people living with chronic disease are the primary decision-makers in their care; it is a tailored approach that builds on the strengths and expertise of patients and helps to ensure that they have the knowledge and skills to be active participants within the medical encounter and to effectively manage their conditions. Incorporating health coaches into care delivery fits well with the of integrated care model recommended by the American Thoracic Society which is based on the Chronic Care Mode. Health coaching can work on several components of the Chronic Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote patient goals. Health coaches provide decision support by helping execute customized care plans jointly developed by patients and providers. Coaches track care targets and conduct 'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the support they need by facilitating access to community, clinic, and specialist support, improving communication between patients and providers, working with patients to set goals and develop action plans to reach those goals. The goal of our study was to evaluate the effectiveness of a health coach model for improving outcomes for low-income urban patients with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual care (health coached arm) to usual care (usual care arm) alone for patients with moderate to severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of the study were:
Specific Aim 1. To compare disease specific quality of life for patients randomized to receive 9 months of health coaching plus usual care to those randomized to usual care alone. Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients in the health-coached arm when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the health coached arm to those in the usual care arm during the 9 month period starting at enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer exacerbations when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached arm to those in the usual care arm. Our hypothesis was that patients in the health-coached arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the health coached arm when tested against the null hypothesis of no difference in self-efficacy between health-coached and usual care patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Coaching | Experimental | Patients randomized to the health coaching intervention would work with a trained health coach who would provide patient education self-management support, use action planning to help patient make changes to reach goals, as well as help coordinate patient care between the primary care provider and pulmonary specialist, identify gaps in care, and help patient access needed services |
|
| Usual care | No Intervention | Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral | Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life. | 9 months |
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of COPD Exacerbations Per Year | A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Version of the Patient Assessment of Quality of Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care. |
Inclusion Criteria:
Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
Age 40 and older
Speaking English or Spanish
Plan to continue to be seen at current clinic and to not leave the area for >2 months anytime in the next 9 months or to be absent at 9 or 15 months
COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) <.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
Willingness to attempt spirometry
At least moderate COPD, defined as at least one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Thom, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Departmen of Public Health Community Clinics | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28599636 | Background | Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3. | |
| 30791871 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Coaching | Major health coach activities: Patient COPD education; Correct use of inhalers and nebulizers; Identifying red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services as needed; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members a |
| FG001 | Usual Care | Usual care includes access to specialist consultation via referral by the primary care clinician, access to patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Coaching | Coaching activities: Patient COPD education Correct use of inhalers and nebulizers Red flags and when to seek medical care Dyspnea management Use of oxygen Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations Ensuring appropriate preventive services (pneumovax, flu) Depression screening Reinforcing clinician education and use of treatment guidelines by primary care providers Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan Helping patients to make and keep appointments and obtain needed testing Facilitating communication between patients, pulmonary specialists and primary care providers Connecting with community resources Access to psychosocial services Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program Working with patient family members and caregivers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life. | All participants who completed the CRQ-SF at 9 months | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
9 months
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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 | Health Coaching | Health coaching included the following activities Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation, nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Helping patient obtain prescriptions Identifying gaps in care, areas where care not in line with care plan;Helping patients to make and keep appointments and obtain needed testing; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Helping to access to psychosocial services; Conducting exercise capacity assessment and working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for COPD related diagnosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED visit for COPD related diagnosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
Target sample size was reduced from 250 to 190 due difficulties with recruitment.
The outcome of medication adherence, measured by the Morisky Medication Adherence Scale, was deleted because we did not realized it required a license.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Thom | University of California San Francisco | 415-206-2278 | David.Thom@UCSF.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 8, 2014 | Mar 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2014 | Mar 7, 2019 | SAP_001.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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| Over 9 month study period |
| Exercise Capacity (6-minute Walk Test) | Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity. | 9 months |
| Self-efficacy to Manage Chronic Disease Scale | The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1="not at all confident" and 10='totally confident". The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD. | 9 months |
| 9 months |
| COPD Assessment Test | The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms. | 9 months |
| Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function. | 9 months |
| Proportion (%) of Participants Reporting Current Cigarette Use | Current cigarette use is defined as any use in the past 30 days. | 9 months |
| COPD-related Function (Bed Days Due to Respiratory Problems) | Number of days in past 4 weeks where COPD keep participant in bed all or most of the day. | 9 months |
| Proportion (%) of Participants Demonstrating Adequate Inhaler Use | Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler. | 9 months |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | Okay to get short of breath while exercising | 9 months |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | beneficial to stop smoking | 9 months |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | Okay to be on oxygen for long period | 9 months |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | Smoking does not help breathing | 9 months |
| Rate of Outpatient Visits | Number of outpatient visits per patient per year | Over 9 month study period |
| Rate of ED Visits for COPD | Number of ED visits for COPD per patient per year over 9 month study period | Over 9 month study period |
| Rate of ED Visits Not for COPD | Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period | Over 9 month study period |
| Rate of Hospitalization for COPD | Number of hospitalizations for COPD per patient per year over 9 month study period | Over 9 month study period |
| Rate of Hospitalizations Not for COPD | Number of hospitalizations other than for COPD per patient per year during 9 month study period | Over 9 month study period |
| Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y. |
| 30130430 | Result | Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC. |
| 31937527 | Derived | Willard-Grace R, Chirinos C, Wolf J, DeVore D, Huang B, Hessler D, Tsao S, Su G, Thom DH. Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial. Ann Fam Med. 2020 Jan;18(1):5-14. doi: 10.1370/afm.2461. |
| Lost to Follow-up |
|
| BG001 | Usual Care | Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life. | Mean | Standard Deviation | units on a scale |
|
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea. | missing data | Mean | Standard Deviation | units on a scale |
|
| Rate of COPD exacerbations | A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year. | Mean | Standard Deviation | events per person year |
|
| Exercise capacity (6-Minute Walk Test) | Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity. | Some participants were unable to do this test | Mean | Standard Deviation | meters |
|
| Self-efficacy to Manage Chronic Disease Scale | The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1="not at all confident" and 10='totally confident". The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD. | Mean | Standard Deviation | units on a scale |
|
| Short version of the Patient Assessment of Quality of Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care. | missing data | Mean | Standard Deviation | units on a scale |
|
| COPD Symptoms (COPD Assessment Test) | The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms. | Mean | Standard Deviation | units on a scale |
|
| Lung Function (FEV1 % predicted) | Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function. | We were not able to obtain spirometry on all patients due to contraindications or technical limitations | Mean | Standard Deviation | percent of predicted |
|
| Proportion (%) of Participants reporting Current Cigarette Use | Current cigarette use is defined as any use in the past 30 days. | missing data | Count of Participants | Participants |
|
| Proportion (%) of Participants Demonstrating Adequate Inhaler Use | Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler. | Some participants did not have inhalers prescribed at baseline | Count of Participants | Participants |
|
| COPD-related function (Bed days in past 4 weeks due to respiratory problems) | Number of days in past 4 weeks where COPD keep participant in bed all or most of the day. | missing data | Mean | Standard Deviation | days |
|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | Okay to get short of breath while exercising (correct answer is yes) | question not answered by 2 participants | Count of Participants | Participants |
|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | Beneficial to stop smoking (correct answer is yes) | question not answered by 2 participants | Count of Participants | Participants |
|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | Okay to be on oxygen long term (correct answer) | not answered by 3 participants | Count of Participants | Participants |
|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | Smoking does not help breathing (correct answer) | Question not answered by 3 participants | Count of Participants | Participants |
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| Rate of all outpatient visits | Number of visits to primary care provider, pulmonary specialist or urgent care, per patient per year, over 12 months prior to enrollment | Mean | Standard Deviation | visits per patient per year |
|
| Rate of emergency department (ED) visits for COPD | Number of visits to emergency department for COPD exacerbation, per patient per year, over 12 months prior to enrollment | Mean | Standard Deviation | visits per patient per year |
|
| Rate of all ED visits not for COPD | Number of visits to emergency department not for a COPD exacerbation, per patient per year, over 12 months prior to enrollment | Mean | Standard Deviation | visits per patient per year |
|
| Rate of hospitalizations for COPD | Number of hospital admissions for COPD exacerbation, per patient per year, over 12 months prior to enrollment | Mean | Standard Deviation | hospitalizations per patient per year |
|
| Rate of hospitalizations not for COPD | Number of hospital admissions not for a COPD exacerbation, per patient per year, over 12 months prior to enrollment | Mean | Standard Deviation | hospitalizations per patient per year |
|
| Proportion (%) of participants receiving guideline-concordant medications for COPD | Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D. | unable to determine GOLD classification for 2 patients (1 in each study arm) | Count of Participants | Participants |
|
| Proportion (%) of Patients with a score of >/= 15 on the Patient Health Questionnaire 8 item version | Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of >/= 15 indicates symptoms of at least moderate depression. | missing data on 1 participant | Count of Participants | Participants |
|
| OG001 | Usual Care | Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
|
|
|
| Primary | Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| Secondary | Rate of COPD Exacerbations Per Year | A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year. | Posted | Mean | Standard Deviation | events | Over 9 month study period |
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| Secondary | Exercise Capacity (6-minute Walk Test) | Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity. | Posted | Mean | Standard Deviation | Meters | 9 months |
|
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| Secondary | Self-efficacy to Manage Chronic Disease Scale | The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1="not at all confident" and 10='totally confident". The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| Other Pre-specified | Short Version of the Patient Assessment of Quality of Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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|
| Other Pre-specified | COPD Assessment Test | The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms. | Posted | Mean | Standard Deviation | units on a scale | 9 months |
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| Other Pre-specified | Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function. | Participants completing measurement of FEV1 % Predicted at 9 months | Posted | Mean | Standard Error | Percent of predicted value | 9 months |
|
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| Other Pre-specified | Proportion (%) of Participants Reporting Current Cigarette Use | Current cigarette use is defined as any use in the past 30 days. | Participants reporting smoking status at 9 months | Posted | Count of Participants | Participants | 9 months |
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| Other Pre-specified | COPD-related Function (Bed Days Due to Respiratory Problems) | Number of days in past 4 weeks where COPD keep participant in bed all or most of the day. | Participants reporting bed days at 9 monhts | Posted | Mean | Standard Deviation | Days | 9 months |
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| Other Pre-specified | Proportion (%) of Participants Demonstrating Adequate Inhaler Use | Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler. | Posted | Count of Participants | Participants | 9 months |
|
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| Other Pre-specified | Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | Okay to get short of breath while exercising | Posted | Count of Participants | Participants | 9 months |
|
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| Other Pre-specified | Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | beneficial to stop smoking | Posted | Count of Participants | Participants | 9 months |
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| Other Pre-specified | Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | Okay to be on oxygen for long period | Posted | Count of Participants | Participants | 9 months |
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| Other Pre-specified | Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | Smoking does not help breathing | Posted | Count of Participants | Participants | 9 months |
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| Other Pre-specified | Rate of Outpatient Visits | Number of outpatient visits per patient per year | Posted | Mean | Standard Deviation | visits per patient per year | Over 9 month study period |
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|
|
| Other Pre-specified | Rate of ED Visits for COPD | Number of ED visits for COPD per patient per year over 9 month study period | Posted | Mean | Standard Deviation | Visits per patient per year | Over 9 month study period |
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|
| Other Pre-specified | Rate of ED Visits Not for COPD | Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period | Posted | Mean | Standard Deviation | Visits per patient per year | Over 9 month study period |
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|
|
|
| Other Pre-specified | Rate of Hospitalization for COPD | Number of hospitalizations for COPD per patient per year over 9 month study period | Posted | Mean | Standard Deviation | Hospitalizations per patient per year | Over 9 month study period |
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|
|
|
| Other Pre-specified | Rate of Hospitalizations Not for COPD | Number of hospitalizations other than for COPD per patient per year during 9 month study period | Posted | Mean | Standard Deviation | Hospitalizations per patient per year | Over 9 month study period |
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| Post-Hoc | Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version | Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of >/= 15 indicates symptoms of at least moderate depression. | Posted | Count of Participants | Participants | 9 month study period |
|
|
|
|
| Post-Hoc | Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD. | Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D. | Posted | Count of Participants | Participants | 9 month study period |
|
|
|
|
| 4 |
| 100 |
| 23 |
| 100 |
| 48 |
| 100 |
| EG001 | Usual Care | Patients the usual care arm could be referred to a specialist by their primary care clinician and had access to education classes, smoking cessation classes, psychosocial medicine and nutritional counseling | 2 | 92 | 25 | 92 | 43 | 92 |
| Hospitalization for other than COPD related diagnosis | General disorders | Systematic Assessment |
|
| ED visit for non-COPD related diagnosis | General disorders | Systematic Assessment |
|
Not provided
Not provided
| 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 |
|
| Superiority |
| Superiority |
| Superiority |
Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering. |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |