Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Health Coaching, Health Disparities, Self-management, Chronic Disease Model
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALHealth Coaching
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.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No
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: * Ever Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted * 1 or more emergency department (ED) visit for COPD exacerbation in past 12 months * 1 or more hospital stays for COPD exacerbation in past 12 months * 1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12 months * Ever on home oxygen therapy * Ever outpatient percutaneous oxygen saturation of \</=88% * Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of \</=55mm Hg * At least 3 outpatient visits for COPD in past 12 months AND (a current COPD Assessment Test (CAT) score of \>/=10 OR an modified Medical Research Council (mMRC) score of \>/=2). * Currently using tiotropium inhaler or combination inhaled corticosteroid and long-acting beta agonist
Exclusion criteria
* Unable to participate in the study due to mental or physical impairment * Severe or terminal illness that precludes focus on COPD * No phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | 9 months | 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. |
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of COPD Exacerbations Per Year | Over 9 month study period | 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. |
| Exercise Capacity (6-minute Walk Test) | 9 months | Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity. |
| Self-efficacy to Manage Chronic Disease Scale | 9 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of Participants Demonstrating Adequate Inhaler Use | 9 months | 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. |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | 9 months | Okay to get short of breath while exercising |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | 9 months | beneficial to stop smoking |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | 9 months | Okay to be on oxygen for long period |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | 9 months | Smoking does not help breathing |
| Short Version of the Patient Assessment of Quality of Care (PACIC) | 9 months | 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. |
| Rate of ED Visits for COPD | Over 9 month study period | Number of ED visits for COPD per patient per year over 9 month study period |
| Rate of ED Visits Not for COPD | Over 9 month study period | Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period |
| Rate of Hospitalization for COPD | Over 9 month study period | Number of hospitalizations for COPD per patient per year over 9 month study period |
| Rate of Hospitalizations Not for COPD | Over 9 month study period | Number of hospitalizations other than for COPD per patient per year during 9 month study period |
| Rate of Outpatient Visits | Over 9 month study period | Number of outpatient visits per patient per year |
| COPD Assessment Test | 9 months | 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. |
| Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | 9 months | 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. |
| Proportion (%) of Participants Reporting Current Cigarette Use | 9 months | Current cigarette use is defined as any use in the past 30 days. |
| COPD-related Function (Bed Days Due to Respiratory Problems) | 9 months | Number of days in past 4 weeks where COPD keep participant in bed all or most of the day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 100 |
| 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. | 92 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 2 |
| Overall Study | Lost to Follow-up | 20 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 38 Participants | 71 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 54 Participants | 121 Participants |
| Age, Continuous | 60.7 years STANDARD_DEVIATION 8 | 61.9 years STANDARD_DEVIATION 7.1 | 61.3 years STANDARD_DEVIATION 7.6 |
| COPD-related function (Bed days in past 4 weeks due to respiratory problems) | 2.75 days STANDARD_DEVIATION 6.44 | 3.86 days STANDARD_DEVIATION 6.86 | 3.28 days STANDARD_DEVIATION 6.65 |
| COPD Symptoms (COPD Assessment Test) | 20.6 units on a scale STANDARD_DEVIATION 8.34 | 20.9 units on a scale STANDARD_DEVIATION 7.41 | 20.7 units on a scale STANDARD_DEVIATION 7.89 |
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | 4.39 units on a scale STANDARD_DEVIATION 1.46 | 4.63 units on a scale STANDARD_DEVIATION 1.45 | 4.51 units on a scale STANDARD_DEVIATION 1.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 19 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 73 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Exercise capacity (6-Minute Walk Test) | 305 meters STANDARD_DEVIATION 83.1 | 292 meters STANDARD_DEVIATION 77.5 | 299 meters STANDARD_DEVIATION 80.4 |
| Lung Function (FEV1 % predicted) | 0.55 percent of predicted STANDARD_DEVIATION 0.19 | 0.60 percent of predicted STANDARD_DEVIATION 0.2 | 0.58 percent of predicted STANDARD_DEVIATION 0.2 |
| Proportion (%) of Participants Demonstrating Adequate Inhaler Use | 12 Participants | 5 Participants | 17 Participants |
| Proportion (%) of participants receiving guideline-concordant medications for COPD | 72 Participants | 63 Participants | 135 Participants |
| Proportion (%) of Participants reporting Current Cigarette Use | 54 Participants | 45 Participants | 99 Participants |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | 75 Participants | 64 Participants | 139 Participants |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | 83 Participants | 75 Participants | 158 Participants |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | 67 Participants | 50 Participants | 117 Participants |
| Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | 96 Participants | 85 Participants | 181 Participants |
| Proportion (%) of Patients with a score of >/= 15 on the Patient Health Questionnaire 8 item version | 13 Participants | 17 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 56 Participants | 109 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) White | 29 Participants | 12 Participants | 41 Participants |
| Rate of all ED visits not for COPD | 1.12 visits per patient per year STANDARD_DEVIATION 2.52 | 0.62 visits per patient per year STANDARD_DEVIATION 1.29 | 0.88 visits per patient per year STANDARD_DEVIATION 2.03 |
| Rate of all outpatient visits | 6.62 visits per patient per year STANDARD_DEVIATION 5.43 | 6.53 visits per patient per year STANDARD_DEVIATION 4.08 | 6.58 visits per patient per year STANDARD_DEVIATION 4.82 |
| Rate of COPD exacerbations | 0.95 events per person year STANDARD_DEVIATION 1.57 | 0.92 events per person year STANDARD_DEVIATION 1.34 | 0.94 events per person year STANDARD_DEVIATION 1.46 |
| Rate of emergency department (ED) visits for COPD | 0.54 visits per patient per year STANDARD_DEVIATION 1.26 | 0.62 visits per patient per year STANDARD_DEVIATION 1.19 | 0.58 visits per patient per year STANDARD_DEVIATION 1.23 |
| Rate of hospitalizations for COPD | 0.13 hospitalizations per patient per year STANDARD_DEVIATION 0.39 | 0.34 hospitalizations per patient per year STANDARD_DEVIATION 0.77 | 0.23 hospitalizations per patient per year STANDARD_DEVIATION 0.61 |
| Rate of hospitalizations not for COPD | 0.21 hospitalizations per patient per year STANDARD_DEVIATION 0.57 | 0.18 hospitalizations per patient per year STANDARD_DEVIATION 0.44 | 0.20 hospitalizations per patient per year STANDARD_DEVIATION 0.51 |
| Self-efficacy to Manage Chronic Disease Scale | 6.36 units on a scale STANDARD_DEVIATION 2.23 | 6.45 units on a scale STANDARD_DEVIATION 2.11 | 6.40 units on a scale STANDARD_DEVIATION 2.17 |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 66 Participants |
| Sex: Female, Male Male | 67 Participants | 59 Participants | 126 Participants |
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | 4.24 units on a scale STANDARD_DEVIATION 1.22 | 4.28 units on a scale STANDARD_DEVIATION 1.23 | 4.26 units on a scale STANDARD_DEVIATION 1.22 |
| Short version of the Patient Assessment of Quality of Care (PACIC) | 3.58 units on a scale STANDARD_DEVIATION 0.98 | 3.29 units on a scale STANDARD_DEVIATION 1.2 | 3.45 units on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 100 | 2 / 92 |
| other Total, other adverse events | 48 / 100 | 43 / 92 |
| serious Total, serious adverse events | 23 / 100 | 25 / 92 |
Outcome results
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | 4.98 units on a scale | Standard Deviation 1.39 |
| Usual Care | Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | 4.78 units on a scale | Standard Deviation 1.49 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.295% CI: [-0.13, 0.65]Mixed Models Analysis
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.
Time frame: 9 months
Population: All participants who completed the CRQ-SF at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | 4.58 units on a scale | Standard Deviation 1.25 |
| Usual Care | Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | 4.43 units on a scale | Standard Deviation 1.28 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.3595% CI: [-0.15, 0.43]Mixed Models Analysis
Secondary
Exercise Capacity (6-minute Walk Test)
Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Exercise Capacity (6-minute Walk Test) | 326 Meters | Standard Deviation 68.3 |
| Usual Care | Exercise Capacity (6-minute Walk Test) | 311 Meters | Standard Deviation 73.8 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.3295% CI: [-8.18, 25.26]Mixed Models Analysis
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.
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of COPD Exacerbations Per Year | 1.17 events | Standard Deviation 1.87 |
| Usual Care | Rate of COPD Exacerbations Per Year | 1.44 events | Standard Deviation 2.16 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.1395% CI: [-0.49, 0.07]Mixed Models Analysis
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Self-efficacy to Manage Chronic Disease Scale | 6.84 units on a scale | Standard Deviation 2.01 |
| Usual Care | Self-efficacy to Manage Chronic Disease Scale | 6.50 units on a scale | Standard Deviation 2 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.2795% CI: [-0.23, 0.83]Mixed Models Analysis
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | COPD Assessment Test | 19.1 units on a scale | Standard Deviation 8.8 |
| Usual Care | COPD Assessment Test | 20.2 units on a scale | Standard Deviation 9.25 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.495% CI: [-2.78, 1.12]Mixed Models Analysis
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.
Time frame: 9 months
Population: Participants reporting bed days at 9 monhts
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | COPD-related Function (Bed Days Due to Respiratory Problems) | 2.15 Days | Standard Deviation 5.76 |
| Usual Care | COPD-related Function (Bed Days Due to Respiratory Problems) | 3.64 Days | Standard Deviation 6.81 |
p-value: 0.2995% CI: [-2.07, 0.62]Mixed Models Analysis
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.
Time frame: 9 months
Population: Participants completing measurement of FEV1 % Predicted at 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | 0.55 Percent of predicted value | Standard Error 0.2 |
| Usual Care | Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | .59 Percent of predicted value | Standard Error 0.21 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.9895% CI: [-3, 3]Mixed Models Analysis
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.
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants Demonstrating Adequate Inhaler Use | 27 Participants |
| Usual Care | Proportion (%) of Participants Demonstrating Adequate Inhaler Use | 9 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: <0.00195% CI: [19.6, 59.8]Mixed Models Analysis
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.
Time frame: 9 month study period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD. | 91 Participants |
| Usual Care | Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD. | 72 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.0195% CI: [3.3, 25.9]Mixed Models Analysis
Other Pre-specified
Proportion (%) of Participants Reporting Current Cigarette Use
Current cigarette use is defined as any use in the past 30 days.
Time frame: 9 months
Population: Participants reporting smoking status at 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants Reporting Current Cigarette Use | 29 Participants |
| Usual Care | Proportion (%) of Participants Reporting Current Cigarette Use | 34 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.395% CI: [-33.3, 10.2]Mixed Models Analysis
Other Pre-specified
Proportion (%) of Participants With Correct Answer to Knowledge Question 1
Okay to get short of breath while exercising
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | 54 Participants |
| Usual Care | Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | 56 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.3895% CI: [-9.5, 25.2]Mixed Models Analysis
Other Pre-specified
Proportion (%) of Participants With Correct Answer to Knowledge Question 2
beneficial to stop smoking
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | 67 Participants |
| Usual Care | Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | 73 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.7395% CI: [-9.4, 13.4]Mixed Models Analysis
Other Pre-specified
Proportion (%) of Participants With Correct Answer to Knowledge Question 3
Okay to be on oxygen for long period
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | 51 Participants |
| Usual Care | Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | 52 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.795% CI: [-14, 20.8]Mixed Models Analysis
Other Pre-specified
Proportion (%) of Participants With Correct Answer to Knowledge Question 4
Smoking does not help breathing
Time frame: 9 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | 72 Participants |
| Usual Care | Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | 80 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.9795% CI: [-5.5, 5.3]Mixed Models Analysis
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.
Time frame: 9 month study period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Coaching | Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version | 4 Participants |
| Usual Care | Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version | 16 Participants |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.0195% CI: [-33.1, -4.8]Mixed Models Analysis
Other Pre-specified
Rate of ED Visits for COPD
Number of ED visits for COPD per patient per year over 9 month study period
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of ED Visits for COPD | 0.80 Visits per patient per year | Standard Deviation 1.63 |
| Usual Care | Rate of ED Visits for COPD | 0.89 Visits per patient per year | Standard Deviation 1.99 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.7895% CI: [-0.32, 0.22]Mixed Models Analysis
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
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of ED Visits Not for COPD | 0.98 Visits per patient per year | Standard Deviation 1.89 |
| Usual Care | Rate of ED Visits Not for COPD | 0.83 Visits per patient per year | Standard Deviation 2.33 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.895% CI: [-0.56, 0.4]Mixed Models Analysis
Other Pre-specified
Rate of Hospitalization for COPD
Number of hospitalizations for COPD per patient per year over 9 month study period
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of Hospitalization for COPD | 0.27 Hospitalizations per patient per year | Standard Deviation 0.77 |
| Usual Care | Rate of Hospitalization for COPD | 0.52 Hospitalizations per patient per year | Standard Deviation 1.25 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.3595% CI: [-0.32, 0.06]Mixed Models Analysis
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
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of Hospitalizations Not for COPD | 0.16 Hospitalizations per patient per year | Standard Deviation 0.58 |
| Usual Care | Rate of Hospitalizations Not for COPD | 0.21 Hospitalizations per patient per year | Standard Deviation 0.81 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.3795% CI: [-0.2, 0.04]Mixed Models Analysis
Other Pre-specified
Rate of Outpatient Visits
Number of outpatient visits per patient per year
Time frame: Over 9 month study period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Rate of Outpatient Visits | 7.51 visits per patient per year | Standard Deviation 5.64 |
| Usual Care | Rate of Outpatient Visits | 6.83 visits per patient per year | Standard Deviation 4.73 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.5295% CI: [-0.32, 1.28]Mixed Models Analysis
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.
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Coaching | Short Version of the Patient Assessment of Quality of Care (PACIC) | 3.91 units on a scale | Standard Deviation 0.95 |
| Usual Care | Short Version of the Patient Assessment of Quality of Care (PACIC) | 3.44 units on a scale | Standard Deviation 1.17 |
Comparison: Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.p-value: 0.0295% CI: [0.07, 0.68]Mixed Models Analysis