An interventional study of Health Coaching in Chronic Obstructive Pulmonary Disease (COPD), sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 40 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
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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At least moderate COPD, defined as at least one of the following:
Exclusion Criteria:
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
Behavioral: Health Coaching
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.
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.
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
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
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
Exercise Capacity (6-minute Walk Test)
Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
Time frame: 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.
Time frame: 9 months
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
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
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
Proportion (%) of Participants Reporting Current Cigarette Use
Current cigarette use is defined as any use in the past 30 days.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
Proportion (%) of Participants With Correct Answer to Knowledge Question 1
Okay to get short of breath while exercising
Time frame: 9 months
Proportion (%) of Participants With Correct Answer to Knowledge Question 2
beneficial to stop smoking
Time frame: 9 months
Proportion (%) of Participants With Correct Answer to Knowledge Question 3
Okay to be on oxygen for long period
Time frame: 9 months
Proportion (%) of Participants With Correct Answer to Knowledge Question 4
Smoking does not help breathing
Time frame: 9 months
Rate of Outpatient Visits
Number of outpatient visits per patient per year
Time frame: 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
Time frame: 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
Time frame: Over 9 month study period
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
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
| Milestone | Health Coaching | Usual Care |
|---|---|---|
| Started | 100 | 92 |
| Completed | 75 | 83 |
| Not completed | 25 | 9 |
| Withdrew: Death | 4 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 20 | 7 |
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.
| units on a scale | Health Coaching | Usual Care |
|---|---|---|
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score | 4.58 ± 1.25 | 4.43 ± 1.28 |
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.
| units on a scale | Health Coaching | Usual Care |
|---|---|---|
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) | 4.98 ± 1.39 | 4.78 ± 1.49 |
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.
| events | Health Coaching | Usual Care |
|---|---|---|
| Rate of COPD Exacerbations Per Year | 1.17 ± 1.87 | 1.44 ± 2.16 |
Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
| Meters | Health Coaching | Usual Care |
|---|---|---|
| Exercise Capacity (6-minute Walk Test) | 326 ± 68.3 | 311 ± 73.8 |
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.
| units on a scale | Health Coaching | Usual Care |
|---|---|---|
| Self-efficacy to Manage Chronic Disease Scale | 6.84 ± 2.01 | 6.50 ± 2.00 |
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.
| units on a scale | Health Coaching | Usual Care |
|---|---|---|
| Short Version of the Patient Assessment of Quality of Care (PACIC) | 3.91 ± 0.95 | 3.44 ± 1.17 |
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.
| units on a scale | Health Coaching | Usual Care |
|---|---|---|
| COPD Assessment Test | 19.1 ± 8.80 | 20.2 ± 9.25 |
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.
| Percent of predicted value | Health Coaching | Usual Care |
|---|---|---|
| Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | 0.55 ± 0.20 | .59 ± .21 |
Current cigarette use is defined as any use in the past 30 days.
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants Reporting Current Cigarette Use | 29 | 34 |
Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.
| Days | Health Coaching | Usual Care |
|---|---|---|
| COPD-related Function (Bed Days Due to Respiratory Problems) | 2.15 ± 5.76 | 3.64 ± 6.81 |
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.
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants Demonstrating Adequate Inhaler Use | 27 | 9 |
Okay to get short of breath while exercising
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | 54 | 56 |
beneficial to stop smoking
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | 67 | 73 |
Okay to be on oxygen for long period
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | 51 | 52 |
Smoking does not help breathing
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | 72 | 80 |
Number of outpatient visits per patient per year
| visits per patient per year | Health Coaching | Usual Care |
|---|---|---|
| Rate of Outpatient Visits | 7.51 ± 5.64 | 6.83 ± 4.73 |
Number of ED visits for COPD per patient per year over 9 month study period
| Visits per patient per year | Health Coaching | Usual Care |
|---|---|---|
| Rate of ED Visits for COPD | 0.80 ± 1.63 | 0.89 ± 1.99 |
Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period
| Visits per patient per year | Health Coaching | Usual Care |
|---|---|---|
| Rate of ED Visits Not for COPD | 0.98 ± 1.89 | 0.83 ± 2.33 |
Number of hospitalizations for COPD per patient per year over 9 month study period
| Hospitalizations per patient per year | Health Coaching | Usual Care |
|---|---|---|
| Rate of Hospitalization for COPD | 0.27 ± 0.77 | 0.52 ± 1.25 |
Number of hospitalizations other than for COPD per patient per year during 9 month study period
| Hospitalizations per patient per year | Health Coaching | Usual Care |
|---|---|---|
| Rate of Hospitalizations Not for COPD | 0.16 ± 0.58 | 0.21 ± 0.81 |
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.
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version | 4 | 16 |
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.
| Participants | Health Coaching | Usual Care |
|---|---|---|
| Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD. | 91 | 72 |
Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Coaching | 4/100 (4%) | 23/100 (23%) | 48/100 (48%) |
| Usual Care | 2/92 (2.2%) | 25/92 (27.2%) | 43/92 (46.7%) |
| Event | Health Coaching | Usual Care |
|---|---|---|
| Hospitalization for COPD related diagnosisRespiratory, thoracic and mediastinal disorders | 14/100 | 20/92 |
| Hospitalization for other than COPD related diagnosisGeneral disorders | 9/100 | 8/92 |
| Event | Health Coaching | Usual Care |
|---|---|---|
| ED visit for non-COPD related diagnosisGeneral disorders | 33/100 | 25/92 |
| ED visit for COPD related diagnosisRespiratory, thoracic and mediastinal disorders | 29/100 | 28/92 |
| Age, Categorical(Participants) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 67 | 54 | 121 |
| >=65 years | 33 | 38 | 71 |
| Age, Continuous(years) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Mean | 60.7 ± 8.0 | 61.9 ± 7.1 | 61.3 ± 7.6 |
| Sex: Female, Male(Participants) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Female | 33 | 33 | 66 |
| Male | 67 | 59 | 126 |
| Ethnicity (NIH/OMB)(Participants) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 19 | 32 |
| Not Hispanic or Latino | 87 | 73 | 160 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 2 | 5 | 7 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 53 | 56 | 109 |
| White | 29 | 12 | 41 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 12 | 13 | 25 |
| Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score(units on a scale) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Mean | 4.24 ± 1.22 | 4.28 ± 1.23 | 4.26 ± 1.22 |
| Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)(units on a scale) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Mean | 4.39 ± 1.46 | 4.63 ± 1.45 | 4.51 ± 1.46 |
| Rate of COPD exacerbations(events per person year) | Health Coaching | Usual Care | Total |
|---|---|---|---|
| Mean | 0.95 ± 1.57 | 0.92 ± 1.34 | 0.94 ± 1.46 |
19 further baseline measures are reported on the registry.
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University of California, San Francisco