Trial Outcomes & Findings for Aides in Respiration Health Coaching for COPD (NCT NCT02234284)

Last Updated: 2019-06-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

192 participants

Primary outcome timeframe

9 months

Results posted on

2019-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	100	92
Overall Study COMPLETED	75	83
Overall Study NOT COMPLETED	25	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Death	4	2
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	20	7

Baseline Characteristics

missing data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=100 Participants	0 Participants n=92 Participants	0 Participants n=192 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=100 Participants	54 Participants n=92 Participants	121 Participants n=192 Participants
Age, Categorical >=65 years	33 Participants n=100 Participants	38 Participants n=92 Participants	71 Participants n=192 Participants
Age, Continuous	60.7 years STANDARD_DEVIATION 8.0 • n=100 Participants	61.9 years STANDARD_DEVIATION 7.1 • n=92 Participants	61.3 years STANDARD_DEVIATION 7.6 • n=192 Participants
Sex: Female, Male Female	33 Participants n=100 Participants	33 Participants n=92 Participants	66 Participants n=192 Participants
Sex: Female, Male Male	67 Participants n=100 Participants	59 Participants n=92 Participants	126 Participants n=192 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=100 Participants	19 Participants n=92 Participants	32 Participants n=192 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=100 Participants	73 Participants n=92 Participants	160 Participants n=192 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=100 Participants	0 Participants n=92 Participants	0 Participants n=192 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=100 Participants	2 Participants n=92 Participants	4 Participants n=192 Participants
Race (NIH/OMB) Asian	2 Participants n=100 Participants	5 Participants n=92 Participants	7 Participants n=192 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=100 Participants	2 Participants n=92 Participants	3 Participants n=192 Participants
Race (NIH/OMB) Black or African American	53 Participants n=100 Participants	56 Participants n=92 Participants	109 Participants n=192 Participants
Race (NIH/OMB) White	29 Participants n=100 Participants	12 Participants n=92 Participants	41 Participants n=192 Participants
Race (NIH/OMB) More than one race	1 Participants n=100 Participants	2 Participants n=92 Participants	3 Participants n=192 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=100 Participants	13 Participants n=92 Participants	25 Participants n=192 Participants
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score	4.24 units on a scale STANDARD_DEVIATION 1.22 • n=100 Participants	4.28 units on a scale STANDARD_DEVIATION 1.23 • n=92 Participants	4.26 units on a scale STANDARD_DEVIATION 1.22 • n=192 Participants
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 • n=99 Participants • missing data	4.63 units on a scale STANDARD_DEVIATION 1.45 • n=91 Participants • missing data	4.51 units on a scale STANDARD_DEVIATION 1.46 • n=190 Participants • missing data
Rate of COPD exacerbations	0.95 events per person year STANDARD_DEVIATION 1.57 • n=100 Participants	0.92 events per person year STANDARD_DEVIATION 1.34 • n=92 Participants	0.94 events per person year STANDARD_DEVIATION 1.46 • n=192 Participants
Exercise capacity (6-Minute Walk Test)	305 meters STANDARD_DEVIATION 83.1 • n=71 Participants • Some participants were unable to do this test	292 meters STANDARD_DEVIATION 77.5 • n=65 Participants • Some participants were unable to do this test	299 meters STANDARD_DEVIATION 80.4 • n=136 Participants • Some participants were unable to do this test
Self-efficacy to Manage Chronic Disease Scale	6.36 units on a scale STANDARD_DEVIATION 2.23 • n=100 Participants	6.45 units on a scale STANDARD_DEVIATION 2.11 • n=92 Participants	6.40 units on a scale STANDARD_DEVIATION 2.17 • n=192 Participants
Short version of the Patient Assessment of Quality of Care (PACIC)	3.58 units on a scale STANDARD_DEVIATION .98 • n=93 Participants • missing data	3.29 units on a scale STANDARD_DEVIATION 1.20 • n=85 Participants • missing data	3.45 units on a scale STANDARD_DEVIATION 1.10 • n=178 Participants • missing data
COPD Symptoms (COPD Assessment Test)	20.6 units on a scale STANDARD_DEVIATION 8.34 • n=100 Participants	20.9 units on a scale STANDARD_DEVIATION 7.41 • n=92 Participants	20.7 units on a scale STANDARD_DEVIATION 7.89 • n=192 Participants
Lung Function (FEV1 % predicted)	0.55 percent of predicted STANDARD_DEVIATION 0.19 • n=79 Participants • We were not able to obtain spirometry on all patients due to contraindications or technical limitations	0.60 percent of predicted STANDARD_DEVIATION 0.20 • n=73 Participants • We were not able to obtain spirometry on all patients due to contraindications or technical limitations	0.58 percent of predicted STANDARD_DEVIATION 0.20 • n=152 Participants • We were not able to obtain spirometry on all patients due to contraindications or technical limitations
Proportion (%) of Participants reporting Current Cigarette Use	54 Participants n=99 Participants • missing data	45 Participants n=85 Participants • missing data	99 Participants n=184 Participants • missing data
Proportion (%) of Participants Demonstrating Adequate Inhaler Use	12 Participants n=95 Participants • Some participants did not have inhalers prescribed at baseline	5 Participants n=83 Participants • Some participants did not have inhalers prescribed at baseline	17 Participants n=178 Participants • Some participants did not have inhalers prescribed at baseline
COPD-related function (Bed days in past 4 weeks due to respiratory problems)	2.75 days STANDARD_DEVIATION 6.44 • n=99 Participants • missing data	3.86 days STANDARD_DEVIATION 6.86 • n=90 Participants • missing data	3.28 days STANDARD_DEVIATION 6.65 • n=189 Participants • missing data
Proportion (%) of Participants With Correct Answer to Knowledge Question 1	75 Participants n=100 Participants • question not answered by 2 participants	64 Participants n=90 Participants • question not answered by 2 participants	139 Participants n=190 Participants • question not answered by 2 participants
Proportion (%) of Participants With Correct Answer to Knowledge Question 2	83 Participants n=100 Participants • question not answered by 2 participants	75 Participants n=90 Participants • question not answered by 2 participants	158 Participants n=190 Participants • question not answered by 2 participants
Proportion (%) of Participants With Correct Answer to Knowledge Question 3	67 Participants n=99 Participants • not answered by 3 participants	50 Participants n=89 Participants • not answered by 3 participants	117 Participants n=188 Participants • not answered by 3 participants
Proportion (%) of Participants With Correct Answer to Knowledge Question 4	96 Participants n=99 Participants • Question not answered by 3 participants	85 Participants n=90 Participants • Question not answered by 3 participants	181 Participants n=189 Participants • Question not answered by 3 participants
Rate of all outpatient visits	6.62 visits per patient per year STANDARD_DEVIATION 5.43 • n=100 Participants	6.53 visits per patient per year STANDARD_DEVIATION 4.08 • n=92 Participants	6.58 visits per patient per year STANDARD_DEVIATION 4.82 • n=192 Participants
Rate of emergency department (ED) visits for COPD	0.54 visits per patient per year STANDARD_DEVIATION 1.26 • n=100 Participants	0.62 visits per patient per year STANDARD_DEVIATION 1.19 • n=92 Participants	0.58 visits per patient per year STANDARD_DEVIATION 1.23 • n=192 Participants
Rate of all ED visits not for COPD	1.12 visits per patient per year STANDARD_DEVIATION 2.52 • n=100 Participants	0.62 visits per patient per year STANDARD_DEVIATION 1.29 • n=92 Participants	0.88 visits per patient per year STANDARD_DEVIATION 2.03 • n=192 Participants
Rate of hospitalizations for COPD	0.13 hospitalizations per patient per year STANDARD_DEVIATION 0.39 • n=100 Participants	0.34 hospitalizations per patient per year STANDARD_DEVIATION 0.77 • n=92 Participants	0.23 hospitalizations per patient per year STANDARD_DEVIATION 0.61 • n=192 Participants
Rate of hospitalizations not for COPD	0.21 hospitalizations per patient per year STANDARD_DEVIATION 0.57 • n=100 Participants	0.18 hospitalizations per patient per year STANDARD_DEVIATION 0.44 • n=92 Participants	0.20 hospitalizations per patient per year STANDARD_DEVIATION 0.51 • n=192 Participants
Proportion (%) of participants receiving guideline-concordant medications for COPD	72 Participants n=99 Participants • unable to determine GOLD classification for 2 patients (1 in each study arm)	63 Participants n=91 Participants • unable to determine GOLD classification for 2 patients (1 in each study arm)	135 Participants n=190 Participants • unable to determine GOLD classification for 2 patients (1 in each study arm)
Proportion (%) of Patients with a score of >/= 15 on the Patient Health Questionnaire 8 item version	13 Participants n=100 Participants • missing data on 1 participant	17 Participants n=91 Participants • missing data on 1 participant	30 Participants n=191 Participants • missing data on 1 participant

PRIMARY outcome

Timeframe: 9 months

Population: All participants who completed the CRQ-SF at 9 months

Outcome measures

Outcome measures
Measure	Health Coaching n=75 Participants 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	Usual Care n=83 Participants 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.
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score	4.58 units on a scale Standard Deviation 1.25	4.43 units on a scale Standard Deviation 1.28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=75 Participants 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	Usual Care n=83 Participants 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.
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	4.78 units on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of COPD Exacerbations Per Year	1.17 events Standard Deviation 1.87	1.44 events Standard Deviation 2.16

SECONDARY outcome

Timeframe: 9 months

Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.

Outcome measures

Outcome measures
Measure	Health Coaching n=37 Participants 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	Usual Care n=42 Participants 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.
Exercise Capacity (6-minute Walk Test)	326 Meters Standard Deviation 68.3	311 Meters Standard Deviation 73.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=73 Participants 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	Usual Care n=83 Participants 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.
Self-efficacy to Manage Chronic Disease Scale	6.84 units on a scale Standard Deviation 2.01	6.50 units on a scale Standard Deviation 2.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=72 Participants 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	Usual Care n=72 Participants 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.
Short Version of the Patient Assessment of Quality of Care (PACIC)	3.91 units on a scale Standard Deviation 0.95	3.44 units on a scale Standard Deviation 1.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=83 Participants 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.
COPD Assessment Test	19.1 units on a scale Standard Deviation 8.80	20.2 units on a scale Standard Deviation 9.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: Participants completing measurement of FEV1 % Predicted at 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=55 Participants 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	Usual Care n=54 Participants 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.
Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)	0.55 Percent of predicted value Standard Error 0.20	.59 Percent of predicted value Standard Error .21

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: Participants reporting smoking status at 9 months

Current cigarette use is defined as any use in the past 30 days.

Outcome measures

Outcome measures
Measure	Health Coaching n=77 Participants 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	Usual Care n=81 Participants 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.
Proportion (%) of Participants Reporting Current Cigarette Use	29 Participants	34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Population: Participants reporting bed days at 9 monhts

Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=83 Participants 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.
COPD-related Function (Bed Days Due to Respiratory Problems)	2.15 Days Standard Deviation 5.76	3.64 Days Standard Deviation 6.81

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Coaching n=70 Participants 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	Usual Care n=77 Participants 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.
Proportion (%) of Participants Demonstrating Adequate Inhaler Use	27 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Okay to get short of breath while exercising

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=82 Participants 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.
Proportion (%) of Participants With Correct Answer to Knowledge Question 1	54 Participants	56 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

beneficial to stop smoking

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=82 Participants 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.
Proportion (%) of Participants With Correct Answer to Knowledge Question 2	67 Participants	73 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Okay to be on oxygen for long period

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=82 Participants 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.
Proportion (%) of Participants With Correct Answer to Knowledge Question 3	51 Participants	52 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months

Smoking does not help breathing

Outcome measures

Outcome measures
Measure	Health Coaching n=74 Participants 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	Usual Care n=82 Participants 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.
Proportion (%) of Participants With Correct Answer to Knowledge Question 4	72 Participants	80 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 9 month study period

Number of outpatient visits per patient per year

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of Outpatient Visits	7.51 visits per patient per year Standard Deviation 5.64	6.83 visits per patient per year Standard Deviation 4.73

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 9 month study period

Number of ED visits for COPD per patient per year over 9 month study period

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of ED Visits for COPD	0.80 Visits per patient per year Standard Deviation 1.63	0.89 Visits per patient per year Standard Deviation 1.99

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of ED Visits Not for COPD	0.98 Visits per patient per year Standard Deviation 1.89	0.83 Visits per patient per year Standard Deviation 2.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 9 month study period

Number of hospitalizations for COPD per patient per year over 9 month study period

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of Hospitalization for COPD	0.27 Hospitalizations per patient per year Standard Deviation 0.77	0.52 Hospitalizations per patient per year Standard Deviation 1.25

OTHER_PRE_SPECIFIED outcome

Timeframe: Over 9 month study period

Number of hospitalizations other than for COPD per patient per year during 9 month study period

Outcome measures

Outcome measures
Measure	Health Coaching n=100 Participants 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	Usual Care n=92 Participants 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.
Rate of Hospitalizations Not for COPD	0.16 Hospitalizations per patient per year Standard Deviation 0.58	0.21 Hospitalizations per patient per year Standard Deviation 0.81

POST_HOC outcome

Timeframe: 9 month study period

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.

Outcome measures

Outcome measures
Measure	Health Coaching n=72 Participants 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	Usual Care n=82 Participants 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.
Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version	4 Participants	16 Participants

POST_HOC outcome

Timeframe: 9 month study period

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.

Outcome measures

Outcome measures
Measure	Health Coaching n=99 Participants 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	Usual Care n=91 Participants 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.
Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD.	91 Participants	72 Participants

Adverse Events

Health Coaching

Serious events: 23 serious events

Other events: 48 other events

Deaths: 4 deaths

Usual Care

Serious events: 25 serious events

Other events: 43 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Health Coaching n=100 participants at risk 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	Usual Care n=92 participants at risk 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
Respiratory, thoracic and mediastinal disorders Hospitalization for COPD related diagnosis	14.0% 14/100 • Number of events 20 • 9 months	21.7% 20/92 • Number of events 35 • 9 months
General disorders Hospitalization for other than COPD related diagnosis	9.0% 9/100 • Number of events 12 • 9 months	8.7% 8/92 • Number of events 14 • 9 months

Other adverse events

Other adverse events
Measure	Health Coaching n=100 participants at risk 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	Usual Care n=92 participants at risk 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
Respiratory, thoracic and mediastinal disorders ED visit for COPD related diagnosis	29.0% 29/100 • Number of events 59 • 9 months	30.4% 28/92 • Number of events 57 • 9 months
General disorders ED visit for non-COPD related diagnosis	33.0% 33/100 • Number of events 73 • 9 months	27.2% 25/92 • Number of events 57 • 9 months

Additional Information

Dr. David Thom

University of California San Francisco

Phone: 415-206-2278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place