Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: University of California, San Francisco

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Study Protocol 
Aides in Respiration (AIR) Health Coaching for Patients with COPD 
NCT02234284 
Last Updated September 8, 2014 
Uploaded March 7, 2019 
 
Each document must include a cover page with the Official Title of the study, NCT number (if 
available), and date of the document. 
 
A. Goals and Aims 
The goal of the Aides in Respiration (AIR) 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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B. Study Design 
Nine-month randomized controlled parallel trial, single-blinded. 
 
C. Setting  
This study was conducted at seven urban county-operated primary care clinics designated as 
federally qualified health centers (FQHCs) that primarily serve a low-income, publically insured 
patient population. Two of these sites are large academic residency teaching practices based at 
the public hospital that is part of the county-owned system. Pulmonary specialty care is available 
through the public hospital that is part of the health network. Clinic sites have integrated 
behavioral health services. All sites have had prior exposure to health coaching for diabetes, 
hypertension, and/or as part of complex care management programs. 
 
D. Participants 
The study enrolled low income and vulnerable patients receiving care FQHCs because these 
patients experience disparities in quality of care and disease burden and have been 
underrepresented in clinical research studies of COPD.  Multiple clinic sites were necessary to 
obtain an adequate sample size.   
 
E. Inclusion and exclusion criteria:  
In addition to meeting diagnostic criteria for COPD, clinical inclusion for having moderate to 
severe COPD required at least one of the following:  
At least one hospital admission due to COPD-related diagnosis in the last 12 months; 
At least two emergency department visits due to COPD-related diagnosis in the last 12 
months; 
Prescription of short term oral steroids (at least 40 mg for at least 5 days but <21 days) for 
respiratory symptoms in the last 12 months; 
Current prescription of anticholinergic inhaler; 
Current prescription of combination long-acting bronchodilator and corticosteroid inhaler; 
Prescription of home oxygen therapy (ever); 
Post-bronchodilator forced expiratory volume over 1 second (FEV1) < 80% of predicted 
(ever); 
Resting O2 Saturation <= 88% as an outpatient (ever); 
Arterial blood gas (ABG/PPO2) <=55 mm Hg as an outpatient (ever). 
Non-clinical inclusion criteria were all of the following: 
Age > 40 years; 
Able to be reached by telephone; 
Speaking Spanish or English;  

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Currently a patient at one of the 7 participating clinic sites with at least 1 outpatient visit 
within the last 12 months and planning to continue care at clinic for the next 9 months; 
Planning to be in San Francisco area for at least 6 of the next 9 months, including at the end 
of study 
Willing to attempt spirometry.  
Exclusion criteria were any of the following: 
Unable to participate in the study as judged by their PCP 
Unable to travel to their primary care clinic 
Unable to complete the enrollment process.   
Spanish speaking patients were recruited by a bilingual research assistant. To maximize 
participation of from under-represented groups, we minimized exclusion criteria.  Specifically, 
we did not exclude patients who were homeless, had substance abuse, mental illness, or other 
conditions as long as they were able to receive health coaching and participate in the study. 
F. Health coaching intervention  
Health coach training.  The two study health coaches were college graduates without medical 
training or certification but who had previously worked with patients in the public health clinic 
system, one as a research assistant and the other as a volunteer health coach.  Both received 
over 100 hours of training over 3 months using a COPD health coaching curriculum specific to 
the study.  The curriculum was comprised of two primary domains: health coaching techniques 
and COPD-specific knowledge. The health coaching curriculum [CEPC website] focused on five 
areas: (1) active listening and non-judgmental communication, (2) helping patients create self-
management goals and action plans, (3) healthcare navigation, (4) medication reconciliation and 
adherence and (5) closing the loop (checking for comprehension by asking patients to describe 
the key messages in their own words). COPD-specific training covered the physiology of COPD, 
related comorbidities, care recommended by the Global Initiative for Chronic Obstructive Lung 
Disease (GOLD),5 prevention and management of exacerbations, and lifestyle management.  
Upon completion of training, coaches were required to score at least 90% on three exams 
assessing content knowledge and to demonstrate mastery of coaching skills through simulated 
role-plays and observed health coaching sessions.  
Health coaching activities.  Patients received health coaching for 9 months. Each health coach 
worked with a total of 50 patients over the two-year duration of the study, with a maximum 
caseload of thirty patients at any given time. Patient needs and preferences guided the 
frequency of contact, with a suggested minimum frequency of connecting with the patient once 
every three weeks. Health coaches were expected to complete an initial visit within 2–3 weeks 
of enrollment, to meet in person with the patient at least 3 additional times over the course of 
the study and to have a phone check-in call at least every 3 weeks, including within two weeks 
after each medical visit.  Coaches were also expected to conduct at least one in-depth 
consultation with the study pulmonary nurse practitioner specialist (PNPS) to optimize patient 
care and to attend at least one medical visit between the patient and their primary care provider 

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(PCP).  Coaches provided patient education, worked with patients to set goals and develop 
action plans to reach those goals, facilitated patient access to clinical care and resources, and 
supported communication between patients, their PCP, and the PNPS. 
As summarized below, coaches interacted with patients in one-on-one in person meetings, by 
telephone and during medical visits.  Coaches also presented patients to the PNPS for 
consultation. 
Initial meeting. The purpose of the initial meeting was to build rapport building and 
understand the patients’ motivations, strengths, and barriers to self-management. 
Subsequent meetings.  Subsequent meetings occurred in person at the clinic or at the 
patient’s home when possible, or by phone if an in-person meeting was not feasible. The 
purpose of these meetings, which generally lasting 15 to 90 minutes, was to set goals or 
address barriers to carrying out goals to assess patient knowledge, share information about 
target conditions, review inhaler use technique, and to assist with navigation of health and 
community resources (including making and keeping appointments, accessing classes and 
smoking cessation resources and meeting with a member of the behavioral health team).  
Home visits were utilized most frequently by patients that had difficulties with public 
transportation or general mobility. Home visits were also used to identify COPD/asthma 
triggers within the home, acquire accurate knowledge of what medications a patient has in 
the home, including any duplicate or expired medications, identify barriers to medication 
adherence, and ensure patients on oxygen have the necessary equipment. 
Phone check-ins.  Phone check-ins were done to provide on-going support for patient self-
management, check for barriers to self-management and provide reminders for up-coming 
appointments.  
Medical visits.  Coaches also meet with patients at the time of their medical visits to conduct 
medication reconciliation, gather clinical information including administration of the COPD 
Assessment Tool, identify gaps in care and help patient to establish priorities and goals for 
the visit prior to the patient seeing the PCP.   With the patient’s permission, the health coach 
was present during the medical visit and could offer clarifications and support as needed. 
After the visit, the health coach reviewed the PCP‘s recommendations with patient to ensure 
patient understanding, and helped patients choose attainable goals and create an action plan 
for making changes to achieve those goals.  The health coach called the patient 
approximately 2 weeks later to follow-up on action plans. 
Consultations with the PNPS. The Health Coach consultation with the PNPS had several steps. 
Health coaches recorded patient medical history and co-morbidities, smoking history, risk and 
symptom assessment, COPD and asthma medications and treatment history, environmental 
triggers and screens for symptoms of sleep apnea, from review of the EMR and information 
supplied by the patient. The health coach then presented the patient’s information to the 
PNPS who could gather additional information from the medial record if needed. The PNPS 
created a set of recommendations for changes in care using the GOLD guidelines, generally 

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without the need to see the patient.     Recommendations could include changes to inhaler 
therapy, further diagnostic testing, and referrals to pulmonology, pulmonary rehabilitation, 
physical therapy, and other appropriate programs. Recommendations were communicated to 
the patient’s PCP via the EMR and/or through secure email.  The Health Coach followed-up 
with the patient to see if the recommendations had be accepted by the primary care provider 
and to provide education and support to the patient for implementing the recommendations.  
 
G. Usual care control group  
Patients randomized to usual care continued to have visits with their primary care provider over 
the course of the 9-month period. They received any resources their provider and their clinic 
offer as part of standard care, including: access to COPD educators, respiratory therapists, COPD 
education classes, pulmonary rehabilitation, or smoking cessation classes.   
 
H. Recruitment and enrollment 
Electronic billing records for the seven clinics and for the county hospital and ED were screened 
for patients with a COPD-related diagnosis (ICD-9 codes 491, 492, 496, 490+305.1, 493+305.1, 
786+305.1) in the past year.  Trained research assistants conducted chart reviews for patients 
identified by ICD-9 codes to gather clinical measures to determine eligibility criteria based on the 
previously stated criteria.  Primary care providers received a list of their patients who appeared 
to be  eligible after chart review and were asked to exclude those with severe physical or 
cognitive impairment, or who were known not be otherwise be eligible (e.g. deceased, no longer 
seen at clinic, or did not speak English or Spanish).  The research associates then attempted to 
contact the remaining patients to confirm eligibility and, if eligible, to offer the chance to enroll 
in the study.  Patients who did not have a COPD diagnosis confirmed by spirometry but who 
otherwise appeared to be eligible were offered spirometry. Eligible patients interested in 
enrolling in the study were scheduled to meet with a research assistant at their primary care 
clinic and were enrolled with informed consent.  Baseline measurements, which included a 
survey, a 6 minute walk test and spirometry, were obtained prior to the patient being 
randomized. 
 
I. Collection of baseline data  
All study participants met with a research assistant (RA) at their primary care clinic.  The 
research assistant administered the Patient Baseline Survey (see Attachments) either in English 
or in Spanish, based on the patient’s preference.  The RA also administered spirometry (see 
Attachments) the 6-minute walk test (see Attachments), and recorded weight, height, blood 
pressure, pulse and O2.   
 
J. Randomization  
A random binary sequence, stratified by site, was used to order study arm assignment into 
sequentially numbered envelopes. Once baseline measures are complete, the research 

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assistant asked the patient to open a sealed envelope with a randomization card indicating 
whether the patient will be assigned to the usual care or health coaching arm. 

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K. Outcomes  
Study outcomes and references for the measures are shown in Table 1 below.  All outcomes 
were measured at baseline and 9 months.  Additional phone surveys at 3 and 6 months ask 
about smoking status, COPD-related quality of life (CRQ-SF) and bed days in past 4 weeks due to 
COPD.  The 3 and 6 month surveys also asked about any ED visits or hospitalization at sites other 
than the county hospital.  Medical records were then requested for these visits.  Participants 

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receive $10 for each measure (survey, exercise capacity test, and spirometry) at baseline, $10 for 
each survey at 3 and 6 months, and $20 for each measure completed at 9 months in 
acknowledgement of their participation in the study.  
COPD-related quality of life (Specific Aim 1) was The Chronic Respiratory Disease Questionnaire 
(CRQ) which generates scores in four domains (dyspnea, fatigue, physical function and mastery) 
and an overall score, has been validated in multiple studies. The CRQ has the advantage of 
having a near normal total score distribution and of being sensitive to change.  and has establish 
minimal clinically important differences for total score and for each of its 4 domain scores 
(dyspnea, fatigue, physical function and mastery)   We chose to use the standardized, self-
administered version of the CRQ due to its ease of  administration and superior discriminant 
validity. 
A COPD exacerbation (Specific Aim 2) was defined as worsening of respiratory symptoms 
resulting in prescription of an antibiotic and/or steroid medication, an unscheduled or 
emergency visit, or a hospitalization.  Similar utilization-based definitions have been used in 
previous studies for moderate to severe exacerbations and is consistent with guideline 
definition.   
Exercise capacity (Specific Aim 3) was measured by the standardized 6 minute walk test (6MWT) 
which measures how far a patient can walk in 6 minutes, was administered by the RA using an 
established protocol recommended by the American Thoracic Society. The distance a patient is 
able to walk in 6 minutes, is a well-recognized and widely used measure of exercise capacity. The 
MICD for the 6MWT is generally considered to be 25 to 50 meters. Previous studies have 
documented the 6MWT is sensitive to measuring change over time.   
Self-efficacy (Specific Aim 4) has been shown to predict functional capacity and quality of life for 
patients with COPD.   We chose to measure self-efficacy using the 6 item scale developed by Dr. 
Kate Lorig and others at Stanford.   
Patient-reported quality of care was measured using the short form of the Patient Assessment 
of Chronic Illness Care (PACIC) 
Level of COPD symptoms was assessed using the  COPD Assessment Test (CAT).   
Lung Function was assessed by spirometry conducted by the research assistant using the VMAX 
Vyntus SPIRO with SentrySuite. All spirometry results were reviewed by the Director of the 
Community Spirometry program to determine quality based on American Thoracic Society (ATS) 
guidelines. To be used, spirometry had to receive a grade of C or higher.  Patients were allowed a 
maximum of 10 attempts at either pre- or post-bronchodilator spirometry. If a patient felt 
unable to complete the test, the RA terminated the attempt and referred the patient to the 
pulmonary function testing (PFT) lab or to a respiratory therapist for testing.   
Smoking status was ascertained by patient self-report.  Patients who reported having smoking at 
all in the past 30 days were considered to be current smokers.  
Patient-reported medication adherence was assessed using the Morisky Medical Adherence 
Scale (MMAS4) 
COPD knowledge was assessed using 10 questions developed for the current study. 

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Inhaler use was observed by research assistants and documented using checklists specific to 
each type of inhaler (see Attachments).  Checklists were based on published checklists and 
consistent with manufacturers’ directions for inhaler use.   
Symptoms of depression in the previous 4 weeks was measured using the Patient Health 
Questionnaire 8-item version (omitting the question asking about suicidal ideation).    
Functional status was measured by patient-self report of number of days unable to do usual 
activities due to COPD (bed days).   
Utilization was assessed at the end of the study by review of EMR and of all records obtained 
from outside hospitals.  
Guideline concordant care included prescription for COPD medication corresponding to GOLD 
recommendation by COPD category (A=low symptoms, low risk; B=high symptoms, low risk, 
C=low symptoms, high risk and D=high symptoms, high risk). 
 
Table 1. Outcomes  with reference to specific aim (SA)  if relevant 
 
Outcomes  
Measure used 
Source 
Reference 
Primary (SA 1) 
 
 
 
COPD-related quality of life 
Short Form Chronic Respiratory 
Disease Questionnaire (SF-CRQ)  
Patient survey 
1-10  
Dyspnea 
SF-CRQ dyspnea sub-scale 
Patient survey 
1-10 
 
 
 
 
Secondary outcomes 
 
 
 
COPD exacerbations (SA 2) 
Review of medical records 
 
11 
Exercise capacity (SA 3) 
6 Minute Walk Test  
Administered by 
RA 
12-16  
Self-efficacy for managing 
COPD (SA 4) 
Stanford Self-Efficacy for 
Managing Chronic Disease  
Patient survey 
17  
 
 
 
 
Other pre-specified 
outcomes 
 
 
 
Patient-reported quality of 
care  
Patient Assessment of Chronic 
Illness Care (PACIC)  
Patient survey 
18 
COPD symptoms 
COPD Assessment Test (CAT)  
Patient survey 
19-21 
Lung function   
Force Expiratory Volume at 1 
second (FEV1)  by spirometry 
Administered by 
RA 
 
Smoking status 
Smoked cigarette in past 30 days Patient survey 
NA 
Medication adherence 
Morisky Medication Adherence 
Scale   
Patient survey 
22,23 
Knowledge of COPD  
Individual questions 
Patient survey 
NA 
Correct use of inhalers 
Inhaler checklist for each type of 
inhaler (adapted) 
Observed by RA 
24-26 

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Functional status 
Bed days due to respiratory 
problems 
Patient survey 
27, 28 
Utilization by type of visit 
Outpatient, urgent care, 
emergency department and 
hospitalizations 
Review of EMR 
NA 
Post-hoc outcomes 
 
 
 
Symptoms of depression 
Patient Health Questionnaire 
(PHQ-8) 
 
29 
Guideline concordant care 
GOLD recommendations 
Patient-report and 
review of EMR 
5 
 
L. Follow-up 
Participant contact information, including phone numbers, address and emails, were obtained 
at enrollment the best way(s) to contact the participant was established.  Participants in both 
study arms were contacted every 3 months by the RA and asked to complete a brief interval 
survey (see attachments) which asked about recent exacerbations, and current smoking status.  
Participants were paid $10 for each interval survey.  To the extent possible, the same RA follow-
up with participant each time to help build trust. For the 9-month, end of study measures, 
which required an in person visit, RAs met with the patient at the patients primary care clinic, 
helping to arrange transportation if needed. The proportion of patients completing surveys 
were similar between study arms at 3 and 6 months, was but higher in usual care arm at 9 
months.  Reasons for withdrawal from the study was documented to the extent possible, based 
on contacting the patient and reviewing the medical record.  
 
M. Sample size 
The original target sample size for enrollment was 250 patients allocated in a 1:1 ratio between 
study arms.  Sample size and power estimates for comparison of the health-coached and usual 
care groups assumed a target power of .80 or higher and significance to be defined by a two-
sided a = 0.05.   Expected effect sizes and minimum clinically important differences (MCIDs) for 
each outcome, were derived from previous studies for the primary measures for the first 3 
aims: COPD-related quality of life,30 number of exacerbations,31 and the 6-minute walk test.32  
Expected differences and minimal clinically important differences were not available for the 
fourth specific aim, patient self-efficacy of COPD management. Based on our previous 
experience in conducting randomized controlled trials in this population,33 (Willard Grace) we 
assumed an attrition rate of 20%, resulting in 200 patients available for analysis at the end of 
the study.  We further assumed an intraclass correlation coefficient (ICC) of 1% between clinic 
sites based on our previous experience. The target sample size gave us sufficient power to 
detect the anticipated differences between groups for each outcome variable, which are at 
least as large as the MCIDs previously established, as shown in the following table. 
 
   Table 2. Original study power based on 100 participants in each arm at end of study 

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Outcome 
MCID* 
Power of 
study to 
detect MCID 
Difference 
expected based on 
previous studies 
Minimum difference 
for which study has 
>80% power 
CRQ-SF total 
1.0 
.99 
.73-2.00 
0.33 
CRQ-SF dyspnea 
0.5 
.88 
.76-1.06 
0.45 
# of exacerbations 
22% 
.90 
20-26% 
20% 
6 minute walk test 
50 m 
.97 
48-85 m 
25 m 
 
As detailed in section F18 below, we were not able to meet our initial goal of 250 patients and 
had modify our enrollment goal to 190 patients that, with a 20% attrition, was expected to yield 
152 patients at the end of the study.  The power for the revised sample size is presented below. 
 
   Table 3. Revised study power based on 76 participants in each arm at end of study 
Outcome 
MCID* 
Power of 
study to 
detect MCID 
Difference 
expected based on 
previous studies 
Minimum difference 
for which study has 
>80% power 
CRQ-SF total 
1.0 
.96 
.73-2.00 
0.45 
CRQ-SF dyspnea 
0.5 
.78 
.76-1.06 
0.51 
# of exacerbations 
22% 
.81 
20-26% 
22% 
6 minute walk test 
50 m 
.92 
48-85 m 
35 m 
 
 
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