Improving the Frequency and Quality of Sleep Apnea Care Management
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: VA Office of Research and Development

 
 
 
 
 
Improving the Frequency and Quality of Sleep Apnea Care Management 
 
ClinicalTrials.gov Identifier: NCT01916655 
 
July 25, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

BACKGROUND: 
Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of 
male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting 
in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly 
efficacious treatment for OSA, adherence with treatment is suboptimal. Because research is clear that 
adherence patterns are established early in treatment, we evaluated an mHealth intervention to 
facilitate early, productive interactions between patient and provider that improve the quality of care 
and ultimately improve adherence with therapy and outcomes. The mHealth interventional approach 
can allow for improved, more timely delivery of our Sleep Apnea Self-Management Program (SM). 
OBJECTIVES: 
The objective of this proposal was to evaluate an mHealth system for patients with Obstructive Sleep 
Apnea syndrome (OSA) that facilitates patient-centered, collaborative management for patients who are 
prescribed the gold-standard treatment, continuous positive airway pressure (CPAP). 
DESIGN & METHODS: 
The evaluative aspect of this proposal is designed as a randomized clinical trial-- Usual Care (Usual Care 
(control; UC); Self-Management Care (intervention 1; SM); and Self-Management via mHealth 
(intervention 2; SM-Mobile). The key feature of the SM-Mobile intervention is the use of a system that 
allows for receiving the SM via website at their convenience. The provider is able provide more directed 
feedback to the patient based on the telemedicine interaction, and the patient benefits from timely 
contact with the provider.  Specific inclusion and exclusion criteria included: age > 18 years; confirmed 
diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as 
noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San 
Diego Healthcare System Sleep Clinic. Participants were enrolled for a 4-month time period.  
FINDING: 
Overall Sample: The overall sample was aged 53.1±13.6, had a body mass index (BMI) of 32.6±5.7, 
apnea-hypopnea index (AHI) of 30.3±18.9, and a baseline Epworth Sleepiness Score (ESS) of 11.8±5.3. 
90% of the sample were men. There were no significant differences between the groups on BMI, AHI, 
ESS, sleep apnea symptoms, insomnia symptoms or depressive symptoms.  
 
Aim 1: To examine the effect of the Self-Management Care delivered by mHealth (SM-Mobile) 
intervention compared to Usual Care (UC) and Self-Management Care (SM) on level of CPAP adherence 
relative to Usual Care. The three groups were compared to see if there were differences on adherence. 
No statistically significant differences were found between UC, SM and SM-Mobile groups at the 2-
month timepoint (4.0±2.2, 3.9±2.4, and 3.8±2.4 hours per night, respectively; F=.113; p=.893). or the 4-
month timepoint (3.6±2.2, 3.6±2.5, and 3.6±2.5 hours per night, respectively; F=.041; p=.959).  
 
In addition, we had CPAP efficacy metrics, including the residual Apnea-Hypopnea Index (AHI) and mask 
leak. At the 4-month time point, CPAP resulted in very good control of sleep apnea as evidenced by the 
mean AHI of 3.3 across the entire group. There were no group differences on residual AHI (UC, SM, and 
SM-Mobile of 3.0, 3.6 and 3.3, respectively). The same was true at the 2-month timepoint (mean 
residual AHI = 3.4; 3.2, 3.7 and 3.5, respectively). Mask leak was also well within normal limits at both 
the 2-month (mean = .14; .11, .15, and .16 lps) and 4-month timepoints (mean = 12; .12, .12, and .13 
lps).  

 
Aim 2: To examine the effect of the SM-Mobile intervention, compared to Usual Care and Self-
Management Care, on the patient’s experience of the quality of patient-centered, collaborative care (as 
measured by the Patient Assessment of Chronic Illness Care [PACIC]). The PACIC results in a total score 
and five subscale scores (Patient Activation, Delivery/support, Goal, Problem-solving, and Follow-up). 
The three intervention groups did not differ statistically (UC, SM, SM-Mobile) (3.3±1.1; 3.4±1.1; 3.4±1.1, 
respectively) on the PACIC Total Score. Higher scores indicated higher ratings of chronic illness care. The 
range of scores for the subscales was 2.6 to 3.7, with the higher overall scores on the Delivery/support 
subscale and the lowest on the Follow-up subscale. Overall, the scores were as high or higher than those 
reported in the literature for patients with similar chronic medical conditions, such as diabetes, asthma, 
depression and arthritis, indicating that the interventions studied in this project resulted in higher than 
average chronic illness care, as rated by patients.  
 
Aim 3: To examine the effect of SM-Mobile, compared to UC and SM, on OSA apnea outcomes (e.g., OSA 
symptoms and OSA-specific health-related quality of life [HRQOL]). The Epworth Sleepiness Scale scores 
dropped from baseline to 2-months by 3.4 points and to 4-months by 4.0 points. Given that the cut-off 
for the ESS is 10 points (above which is considered sleepy; below which is considered within normal 
limits), all three interventions combined to reduce the sleepiness level of the sample from the sleepy 
range to the normal limits range (i.e., from mean ESS score of 11.8 to mean ESS score of 8.4 and 7.8 for 
2-months and 4-months respectively). The mean ESS scores did not differ significantly between the 
groups at either the 2-month timepoint (8.3, 8.5, and 8.5 for the 3 groups respectively, UC, SM and SM-
Mobile) or the 4-month timepoint (7.9, 7.4, and 8.2 for the 3 groups respectively, UC, SM and SM-
Mobile). Sleep quality as measured by the Pittsburgh Sleep Quality Index was also significantly improved 
across all 3 groups from baseline (mean 11.9) to 2-months (2.8 points, mean 9.1) and to 4-months (2.9 
points, mean 9.0). The mean PSQI scores did not differ significantly between the groups at either the 2-
month timepoint (8.7, 9.4, and 9.5 for the 3 groups respectively, UC, SM and SM-Mobile) or the 4-month 
timepoint (8.5, 9.0, and 9.7 for the 3 groups respectively, UC, SM and SM-Mobile). 
 
 
STATISTICAL ANALYSIS PLAN (SAP): 
Data Analytic Plan. Preliminary analyses will begin with an examination of the distribution of variables 
to assess their characteristics (means, standard deviations, skewness, and kurtosis), to provide 
descriptive statistics of the study population, and to allow assessment of randomization. Continuous 
measures will be tested for normality and homogeneity of variance. Non-normally distributed variables 
will be transformed to meet the normal distribution assumption for linear statistical models. 
The research question in the primary aim 1 will be addressed by comparing the CPAP adherence at post-
intervention among the three intervention  groups (UC, SM, SM-Mobile) and secondary aims 2 and 3 will 
be addressed by comparing the three intervention groups (UC, SM, SM-Mobile) on the changes in PACIC, 
OSA symptoms and OSA HRQOL from pre-intervention to post-intervention. The analytic model is based 
on an analysis of variance on the post-intervention measure (primary aim) or the change measures 
(secondary aims). For the change measures, the ANOVA will be accompanied by an analysis of 
covariance (ANCOVA) on the change scores with intervention as a main effect and the corresponding 
baseline measurement (baseline PACIC, OSA symptoms and OSA HRQOL) as the covariate. Adjustments 
will be made to correct for other baseline imbalances between groups, and to adjust for variables 
known to influence outcome independently of intervention. To explore this, univariate methods will be 
used. Each of the following variables will be assessed for imbalance between the three intervention 
groups and their association with each of the outcomes using a univariate analysis (ANOVA, Fisher’s 
exact test or Spearman correlation coefficient as appropriate): age, gender, education and baseline OSA 

severity. These variables will be included as covariates in the ANCOVA model if found to be moderately 
associated (p<0.15) with the outcome under study (CPAP adherence, CAHPS, PACIC, OSA symptoms and 
OSA HRQOL) or unbalanced (p<0.10) among intervention groups. The outcomes in secondary aims 2 and 
3 will also be assessed by the random effects model, which is useful for examining changes in variables 
from clustered or longitudinal data and allows us to account for all levels of clustering when analyzing 
the data. It accommodates unequal time intervals and will include all available data, minimizing the 
effects of missing data on the analyses. The data analytic plan for secondary aim 4, which involves a cost 
analysis among three interventions [and a calcuation of the adherence level per intervention cost], is 
fully described in section D.7 below. An intent-to-treat analysis will be performed and no correction will 
be made for multiple comparisons. All above analyses will be performed in R.110 Given below are 
detailed analysis plans for the primary aim and secondary aims 1 and 2.  
Aim 1: An ANOVA will be used to assess the CPAP adherence at post-intervention among the three 
groups. Followed will be an ANCOVA by including potential covariates. Any variable that is significantly 
different at baseline (p<0.10) and found to be associated with response (p<0.15) as well as any clinically 
significant variables will be included as covariates.  
Aim 2:  An ANOVA will be used to assess the post vs. pre changes in PACIC among the three groups. An 
ANCOVA will be performed with treatment as a main effect and baseline score as a covariate. Any 
variable that is significantly different at baseline (p<0.10) and found to be associated with response 
(p<0.15) as well as any clinically significant variables will be included as covariates. As a secondary 
analysis, the change in PACIC will also be evaluated using a random effects model with a group, time and 
a group-by-time interaction term.  
Aim 3:  An ANOVA will be used to assess the post vs. pre changes in OSA symptoms and OSA HRQOL 
among the three groups. An ANCOVA will be performed with treatment as a main effect and baseline 
score as a covariate. Any variable that is significantly different at baseline (p<0.10) and found to be 
associated with response (p<0.15) as well as any clinically significant variables will be included as 
covariates. As a secondary analysis, a random effects model with a group-by-visit interaction term will 
be used to assess the rate of change in PACIC differs among three intervention groups.  
 
 

VA San Diego Healthcare System
IRB NUMBER: H130350
IRB APPROVAL DATE: 09/27/2017
Department of  Veterans Affairs 
RESEARCH INFORMED CONSENT   Page 1 of 5 
                                         IRB Protocol #: H130350
Title of Study: 
Improving the Frequency and Quality of Sleep Apnea Care Management
Principal Investigator:
Carl J. Stepnowsky, Jr., PhD
VAMC:
VA San Diego Healthcare System
10-1086 VASDHS 20130412 
This document must be stamped 
by the IRB with approval dates
   
1 hk
                   
1) Purpose of this research study
Carl J. Stepnowsky, Jr., PhD and associates are conducting a research study to find out more 
about improving care provided to patients with sleep apnea. You have been asked to participate 
because you have a diagnosis of sleep apnea and have been prescribed continuous positive 
airway pressure (CPAP). There will be approximately 400 participants at this VA site.  The 
funding source of this study is the Department of Veterans Affairs (VA) Health Services 
Research & Development Service (HSR&D).
2) How long the study will take
Your participation will take approximately 30-60 minutes each time you come to the VA hospital, 
and you will be expected to come to the hospital 1-5 times over a 4-month period. The entire 
study will take about 4 years.
3) What will happen to you in this study 
If you agree to be in the study, the following will happen to you:
a.
You will be randomized to one of three groups that are being studied using a 
random number generator.
b.
The three groups will each differ on how the education and clinical support will be 
provided to you, but all three will be at or above the standard level of care. 
c.
You will be asked to follow an educational program that will help you learn to
manage your sleep apnea using CPAP therapy.
d.
You will be asked to complete questionnaires before you start CPAP therapy, and 
then again at two-months and at the end of the 4-month study period.
e.
You will be set-up with the CPAP therapy device and fitted for a mask.  You will be 
instructed on how to use the device and you will be able to call our Respiratory 
Therapist with any questions or problems you have with CPAP.
f.
At a minimum, you will be called by the Respiratory Therapist during the first week 
and scheduled for a face-to-face visit at 1-month visit.
4) Which procedure(s) or treatment(s) are done for research only
Your treatment of sleep apnea with Continuous Positive Airway Pressure (CPAP) therapy is the 
standard of care for your condition, and it is not experimental in this study. What is experimental 
in this study is how the care is organized and delivered to you via two different communication 
methods, either by traditional face-to-face and telephone communication or by the use video 
teleconferencing  via a mobile phone.  Video teleconferencing includes the transmission of 
audio/video, and will be done using the VA-approved Clinical Video Teleconferencing Into the 
Subject Name:
Date:

VA San Diego Healthcare System
IRB NUMBER: H130350
IRB APPROVAL DATE: 09/27/2017
Department of  Veterans Affairs 
RESEARCH INFORMED CONSENT   Page 2 of 5 
                                         IRB Protocol #: H130350
Title of Study: 
Improving the Frequency and Quality of Sleep Apnea Care Management
Principal Investigator:
Carl J. Stepnowsky, Jr., PhD
VAMC:
VA San Diego Healthcare System
10-1086 VASDHS 20130412 
This document must be stamped 
by the IRB with approval dates
   
1 hk
Home (CVTH) service. CVTH uses end-to-end encryption (Advanced Encryption Standard) for 
data security. You will be seen for all of your regularly scheduled clinic visits and will be treated 
at a minimum as you normally would in the Sleep Clinic – this represents the standard of care 
and is not experimental in this study.  
5) RISKS reasonably to be expected
Participation in this program may involve some risks or discomforts.  There is the possible risk of 
loss of confidentiality through participation in research because of access to your medical 
record. Safeguards will be taken to ensure that your confidentiality is not lost. A trained research 
staff member will access your medical record only to obtain data from your sleep study – the 
information the research study requires includes summary indices such as your apnea-
hypopnea index (the number of breathing disturbances per hour of sleep), oxygen desaturation 
index (the number of times your oxygen drops ≥3% per hour of sleep), and total sleep time (the 
total amount of time in minutes that you are asleep). Use of the sleep recording device might 
results in (a) minor irritation to the skin caused by the electrode adhesive or (b) disrupted sleep 
from wearing the sleep equipment, which can result in sleepiness the next day. 
Unforeseeable RISKS 
Because this is an investigational study there may be some unknown risks that are currently 
unforeseeable. You will be informed if the researchers learn of any change in the amount of risk 
to you.
6) BENEFITS reasonably to be expected.
There may or may not be a direct benefit to you from these procedures. The study, however, 
may learn more about how best to organize and deliver care to patients with sleep apnea on 
CPAP.  
7) Voluntary nature of participation and right to withdraw without penalty.
Participation in research is entirely voluntary. You may refuse to participate or withdraw at any 
time without jeopardy to the medical care you will receive at this institution or loss of benefits to 
which you are entitled.  
8) Alternatives to the research procedure or treatment 
The alternatives to participation in this study are: (a) to not participate; (b) to contact your 
current physician regarding any sleep apnea-related problems you may be experiencing, or (c)  
contacting your local A.W.A.K.E. group, which stands for Alert, Well, And Keeping Energetic, 
and is organized by the American Sleep Apnea Association. The goal of this informal group is to 
provide educational and emotional support from other sleep apnea patients – however, this 
does not replace the standard of care provided by your physician and his/her staff.

VA San Diego Healthcare System
IRB NUMBER: H130350
IRB APPROVAL DATE: 09/27/2017
Department of  Veterans Affairs 
RESEARCH INFORMED CONSENT   Page 3 of 5 
                                         IRB Protocol #: H130350
Title of Study: 
Improving the Frequency and Quality of Sleep Apnea Care Management
Principal Investigator:
Carl J. Stepnowsky, Jr., PhD
VAMC:
VA San Diego Healthcare System
10-1086 VASDHS 20130412 
This document must be stamped 
by the IRB with approval dates
   
1 hk
9) Procedure for the orderly termination of a volunteer’s participation
If you decide that you no longer wish to participate in this study please call Tania Zamora at 
858-642-3269. You will be asked to come in for one final visit to complete the last set of 
questionnaires. You should come in for a final visit if you decide to stop participation in this 
study so that the investigators can ensure your health and well-being.
You may be withdrawn from the study by Dr. Stepnowsky for unanticipated circumstances.  
Though unlikely, these circumstances may include: cancellation of the study, you being unable 
to participate due to your health concerns or other reasons, or that your continuation may be 
harmful to you or to others.  You may also be withdrawn from the study if you do not follow the 
instructions given you by the study personnel.
10) Information learned from the study will be shared with you
While you are a participant in this study you will be told if any important new information is found 
that may affect your wanting to continue.
If the results of this research might influence your medical care after you have completed your 
participation, the investigators will contact you to let you know these results.
11) Care provided if you are injured as a result of this study
The VA will provide necessary medical treatment should you be injured as a result of 
participating in this study and following study procedures.  You will be treated for the injury by 
the VA at no cost to you or your insurance but no additional compensation is available.  Every 
reasonable safety measure will be taken to protect your well-being. 
12) Privacy and confidentiality
Participation in this study may involve a loss of privacy, but information about you will be 
handled as confidentially as possible. If study involves treatment, clinical resources, or potential 
for adverse events a CPRS note is required.  
Your research records will be labeled with a code number. The list that matches your name with 
the code number will be kept in a locked file in the research team’s office. The research records 
will be kept only as paper records in a secure VASDHS location, or as files behind the secure 
VASDHS computer firewall. Any presentations or publications from this information will not 
identify you. 
Any presentations or publications from this information will not identify you. 

VA San Diego Healthcare System
IRB NUMBER: H130350
IRB APPROVAL DATE: 09/27/2017
Department of  Veterans Affairs 
RESEARCH INFORMED CONSENT   Page 4 of 5 
                                         IRB Protocol #: H130350
Title of Study: 
Improving the Frequency and Quality of Sleep Apnea Care Management
Principal Investigator:
Carl J. Stepnowsky, Jr., PhD
VAMC:
VA San Diego Healthcare System
10-1086 VASDHS 20130412 
This document must be stamped 
by the IRB with approval dates
   
1 hk
We will keep confidential all research and medical records that identify you to the extent allowed 
by law.  However, you should know that there are some circumstances in which we may have to 
show your information to other people.  For example, the Federal Office of Human Research 
Protections, the General Accounting Office, the VASDHS R&D Committee, the VASDHS 
Institutional Review Board, the VA Health Services Research & Development (the sponsor of 
this study) and federal compliance officers may look at or copy portions of records that identify 
you. 
13) Payment
Costs to you or your insurance 
There will be no costs to you or your insurance for any procedures or testing done only as part 
of this research study.  If you receive a bill for services that you think could be related to your 
participation in this study, you should contact Dr. Stepnowsky at (858)642-1240.
Medical care and services provided by the VA that are not part of this study (e.g., normal 
hospital and prescription expenses which are not part of the research study) may require co-
payments if your VA-eligibility category requires co-payment for VA services.  
You or your insurance company will be charged for any procedure or test that is medically 
necessary for the treatment of your illness, including the CPAP treatment, related tests and 
procedures. You will be responsible for all insurance co-payments and deductibles. The study 
test and procedures will be provided to you at no cost.  
Payment for participating
You will receive payment for participating in this study. You will receive $20 for completion of the 
baseline questionnaires, $20 for completion of the 2-month questionnaire and $35 for 
completion of the final set of questionnaires for a total of $75 for the entire project.
14) Additional Information
The VA San Diego Healthcare System provides oversight and resources for this study.  
15) RESEARCH SUBJECTS' RIGHTS: You have read or have had read to you all of the above. 
You have been informed that you do not have to take part in this study, and your refusal 
to participate will involve no penalty or loss of rights to which you are entitled. You may 
withdraw from this study at any time without penalty or loss of VA or other benefits to 
which you are entitled.
In the event of illness or injury that you believe to be related to the study, or have questions 
about this research, you can call Dr. Stepnowsky at (858)642-1240 during the day.  If you have 

VA San Diego Healthcare System
IRB NUMBER: H130350
IRB APPROVAL DATE: 09/27/2017
Department of  Veterans Affairs 
RESEARCH INFORMED CONSENT   Page 5 of 5 
                                         IRB Protocol #: H130350
Title of Study: 
Improving the Frequency and Quality of Sleep Apnea Care Management
Principal Investigator:
Carl J. Stepnowsky, Jr., PhD
VAMC:
VA San Diego Healthcare System
10-1086 VASDHS 20130412 
This document must be stamped 
by the IRB with approval dates
   
1 hk
any questions or concerns about your rights as a research subject, the validity of a research 
study, or research personnel you can contact the Research Compliance Officer at 858-642-
3817, VA Research Service at 858-642-3657, VA Regional Counsel at 858-642-1540, or the 
VASDHS Human Research Protection Program at 858-642-6320.
__________________ has explained the study to you and answered all of your questions. You 
have been told of the risks or discomforts and possible benefits of the study.  You have been 
told of other choices of treatment available to you.  You will receive a copy of this consent form 
and a copy of the Health Insurance Portability and Accountability Act (HIPAA) Authorization that 
you signed.  You will also receive a copy of the California Experimental Subject's Bill of Rights. 
By signing this form you indicate that you have been informed of your rights as a research 
subject, and that you voluntarily consent to participate in this study.  You have been informed 
what the study is about and how and why it is being done.
Subject's Signature
Date
       
                
            
                   
     
Signature of Researcher obtaining consent 
           Name (print)         
        Date