Video Consultation as an Adequate Alternative to Face-to-face Consultations in CPAP Use for Patients With Obstructive Sleep Apnea: Randomized Controlled Trial.
Phase: NA
Conditions: Obstructive Sleep Apnea
Sponsor: Rijnstate Hospital

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Research Protocol  
The effects of video consultation on patients’ CPAP use 
regarding CPAP treatment in patients with sleep apnea, a 
randomized controlled trial 
 
 
 
 
 
 
Protocol ID 
 
Title 
The effects of video consultation on patients’ self-
efficacy regarding CPAP treatment in patients with 
sleep apnea, a randomized controlled trial 
Version 
4 
Date 
12-11-2018 
Principal investigator 
Prof. dr. W.H. van Harten 
Coordinating investigator/project leader 
Laura Kooij, MSc 
Sponsor (in Dutch: verrichter/opdrachtgever) 
Rijnstate hospital 
Subsidising party 
NA 
Independent expert (s) 
Dr. N.J.M. Claessens 
Laboratory sites > 
NA 
Pharmacy  
NA 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
INTRODUCTION ............................................................................................................ 5 
2. 
OBJECTIVES ................................................................................................................. 6 
3. 
STUDY DESIGN ............................................................................................................ 6 
4. 
STUDY POPULATION ................................................................................................... 6 
4.1 
Population (base) .................................................................................................... 6 
4.2 
Inclusion criteria ...................................................................................................... 7 
4.3 
Exclusion criteria ..................................................................................................... 7 
4.4 
Sample size calculation ........................................................................................... 7 
5. 
TREATMENT OF SUBJECTS ........................................................................................ 7 
5.1 
Investigational product/treatment ............................................................................. 7 
5.2 
Use of co-intervention (if applicable) ....................................................................... 8 
5.3 
Escape medication (if applicable) ............................................................................ 8 
6. 
INVESTIGATIONAL PRODUCT ..................................................................................... 8 
7. 
NON-INVESTIGATIONAL PRODUCT ............................................................................ 8 
8. 
METHODS ..................................................................................................................... 8 
8.1 
Study parameters/endpoints .................................................................................... 8 
8.1.1 
Main study parameter ....................................................................................... 8 
8.1.2 
Secondary study parameters/endpoints (if applicable) ..................................... 8 
8.1.3 
Other study parameters (if applicable) .............................................................10 
8.2 
Randomisation, blinding and treatment allocation ..................................................10 
8.2.1 
Randomization ................................................................................................10 
8.2.2 
Blinding ...........................................................................................................10 
8.2.3 
Treatment allocation ........................................................................................10 
8.3 
Study procedures ...................................................................................................10 
8.4 
Withdrawal of individual subjects ............................................................................11 
8.4.1 
Specific criteria for withdrawal (if applicable) ...................................................11 
8.5 
Replacement of individual subjects after withdrawal ...............................................11 
8.6 
Follow-up of subjects withdrawn from treatment .....................................................11 
8.7 
Premature termination of the study .........................................................................11 
9. 
SAFETY REPORTING ..................................................................................................11 
10. 
STATISTICAL ANALYSIS ..........................................................................................11 
10.1 
Primary study parameter(s) – self-efficacy (SEMSA subscale) ...............................11 
10.2 
Secondary study parameter(s) – self-efficacy (SEMSA subscale), perceived risk 
(SEMSA subscale), outcome expectancies (SEMSA subscale), adherence, expectations 
and experiences and satisfaction ......................................................................................11 
10.3 
Other study parameters ..........................................................................................12 
10.4 
Interim analysis (if applicable) ................................................................................12 
10.5 
Missing data ...........................................................................................................12 
11. 
ETHICAL CONSIDERATIONS ...................................................................................12 
11.1 
Regulation statement .............................................................................................12 

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11.2 
Recruitment and consent........................................................................................12 
11.3 
Objection by minors or incapacitated subjects (if applicable) ..................................12 
11.4 
Benefits and risks assessment, group relatedness .................................................12 
11.5 
Compensation for injury .........................................................................................13 
11.6 
Incentives (if applicable) .........................................................................................13 
12. 
ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION .........................13 
12.1 
Handling and storage of data and documents ........................................................13 
12.2 
Monitoring and Quality Assurance ..........................................................................13 
12.3 
Amendments ..........................................................................................................13 
All substantial amendments will be notified to the METC and to the competent authority. ....13 
12.4 
Annual progress report ...........................................................................................13 
12.5 
Temporary halt and (prematurely) end of study report ............................................14 
12.6 
Public disclosure and publication policy ..................................................................14 
13. 
STRUCTURED RISK ANALYSIS...............................................................................14 
14. 
REFERENCES ..........................................................................................................14 
Appendix 1 – Study process .................................................................................................16 
Appendix 2 – FaceTalk specifications ...................................................................................17 

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LIST OF ABBREVIATIONS AND RELEVANT DEFINITIONS  
 
AHI 
Apnea-hypopnea index 
CCMO 
Central Committee on Research Involving Human Subjects 
In Dutch: Centrale Commissie Mensgebonden Onderzoek 
CPAP 
Continuous Positive Airway Pressure 
ODI 
Oxygen desaturation index 
OSA 
Obstructive Sleep Apnea 
SEMSA Self-Efficacy Measure for Sleep Apnea 
WMO 
Medical Research Involving Human Subjects Act (in Dutch: Wet Medisch-
wetenschappelijk Onderzoek met Mensen 
 
 
 
 

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1. INTRODUCTION  
 
Obstructive Sleep Apnea (OSA) is a sleep disorder that affects at least 2% - 4% of the adult population 
[1] and is characterized by repeated episodes of full or partial occlusion of the upper airway during 
sleep [1, 2]. OSA can be considered a chronic disease [3] and can have multiple effects on patients’ 
health such as cognitive dysfunction [1], a decrease in health-related quality of life [1, 4], an increase 
in cardiovascular disease risk and sleepiness during daytime [4]. Treatment of OSA is dependent on 
the severity, which can be expressed as the apnea-hypopnea index (AHI), the oxygen desaturation 
index (ODI) and symptoms. The AHI represents the number of apneas and hypopneas per hour [1] 
and is classified as mild (5-15 per hour), moderate (15-30 per hour) or severe (>30 per hour) [5]. 
Continuous Positive Airway Pressure (CPAP) is the treatment of choice [4], especially for moderate to 
severe OSA [2]. CPAP prevents the airway to narrow or collapse by applying a positive pressure via a 
nasal mask during sleep [6] and tailored to each individual patient [7]. However, treatment adherence 
is often problematic  [8, 9] especially due to the discomfort of the mask and the machine [8, 9]. As the 
effectiveness of CPAP is dependent on the use [2, 10] good adherence is essential. 
 
Participation of patients in their own treatment [11], a closer follow-up [12] and support during 
treatment [13] can positively affect adherence. Patients often decide at an early stage of the treatment 
process whether or not to use the CPAP machine [14], and this start can be predictive of further use 
[15]. Behavior change is considered a relevant factor for CPAP use [14] and treatment self-efficacy 
can be an important factor for behavior change  [16]. Patients’ perceived self-efficacy is “is concerned 
with judgments of how well one can execute courses of action required to deal with prospective 
situations” [16].  
 
Video consultation is a useful way of supporting OSA patients during their treatment [12, 17] and is 
defined as a “technology used to realize a real-time visual and audio patient assessment at a distance” 
[18]. It has been successful in chronic conditions for example diabetes [19], cancer [20] and in care for 
OSA patients [17]. A recent review described five studies that used video consultation for CPAP 
treatment [21], of which the outcomes included patient satisfaction [12, 17, 22] and compliance [17, 
22, 23]. Isetta et al. [12] conducted two studies, one to assess patients’ satisfaction about the video 
consultation. The second study was an RCT in which 40 patients were trained to use CPAP. The 
results show that patients were positive about the use of video consultations and willing to replace 
future face-to-face consultations with a video consultation. Patients’ knowledge after receiving training 
about OSA and CPAP via video consultation was comparable to the knowledge of patients that 
received the same training face-to-face [12]. In a nurse educational intervention, supported by video 
consultation, satisfaction and adherence was also evaluated in patients who were nonadherent during 
the first 3 months of their treatment. This study showed a positive effect on CPAP treatment 
adherence and patients’ satisfaction [22]. In a multicenter RCT a telemedicine follow-up intervention 
was compared with hospital (face-to-face) follow-up to evaluate effects on cost-effectiveness, 
compliance and quality of life. Patients in the telemedicine group received access to a website with 

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information about CPAP and OSA. Professionals’ monitored patients’ answers to questionnaires about 
for example CPAP, status and sleep time. The website was also used for communication and video 
consultation. Patients in hospital group received face-to-face follow-up consultations. The results show 
that telemedicine was more cost-effective. The levels of CPAP compliance and satisfaction were 
comparable in both groups [23].  
Parikh et al [17] compared the effects of video consultations, used for OSA patients that will receive 
CPAP treatment, in a controlled setting to compare satisfaction and CPAP adherence. Surveys were 
used to measure satisfaction and adherence was analyzed using a retrospective cohort. No 
differences in patients’ satisfaction and compliance comparing a group patients with CPAP treatment 
[17].  
 
Multiple studies have evaluated the use of video consultation for OSA patients treated with CPAP on 
treatment adherence [17, 22, 23]. However, there is lack of knowledge about the effects of video 
consultation on CPAP treatment adherence for new patients during their CPAP treatment. Because 
self-efficacy can be an important element for treatment adherence [24], more knowledge is also 
needed about the effects of video consultation on patient’s self-efficacy. 
 
2. OBJECTIVES 
 
We will evaluate the effects of video consultation versus face-to-face and consultations by telephone 
for patients with sleep apnea in terms of patients’ CPAP use (minutes/per night) (primary outcome). 
Also the effects on self-efficacy, risk perception, outcome expectancy, CPAP adherence, video 
consultation expectations and experiences, and patients’ and professionals’ satisfaction will be 
assessed (secondary outcomes). 
 
3. STUDY DESIGN 
 
The study will be a randomized controlled trial with an intervention group (video consultation) and a 
usual care control group (1:1 allocation), with assessments at baseline and after four weeks. The 
intervention group, receiving video consultation combined with face-to-face consultations during their 
treatment with CPAP, will be compared to a control group receiving face-to-face and consultations by 
telephone. A detailed description of the intervention can be found in paragraph 5.1 and a detailed 
description of the study procedure in paragraph 8.3. 
 
4. STUDY POPULATION 
4.1 Population (base)  
We will include Dutch patients with confirmed obstructive sleep apnea (OSA) (AHI > 15) that will be 
starting treatment with CPAP at the Rijnstate hospital in Arnhem. Annually, approximately 475 patients 

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(2017) with OSA (AHI > 15) are being treated with CPAP in Rijnstate. We will be able to include 
approximately 140 patients in a 6 month period assuming an uptake of 60%. 
 
4.2 Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet all of the following criteria: 
• 
diagnosed with moderate or severe sleep apnea AHI > 15 
• 
patients will be treated with CPAP 
• 
Age > 18 years 
• 
no history of CPAP treatment  
• 
having (access to) a tablet or smartphone  
o 
with a (integrated) webcam, speakers, microphone 
o 
working internet connection 
o 
access to the browsers Chrome, Firefox, Internet Explorer or Safari. 
• 
able to use a tablet or smartphone (including a web-cam) 
• 
ability to read and understand the Dutch language  
• 
signed informed consent 
 
4.3 Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation in this 
study: 
• 
having a severe cognitive or psychiatric disorder  
 
4.4 Sample size calculation 
In total, 126 patients will be required for our primary study objective, n=63 in the intervention and n=63 
in the control group. For CPAP adherence we assumed that a difference of 1 h/day of average CPAP 
use is clinically significant (SD 2.0)[23, 25]. Using a t-test, alpha of 0.05, and 80% power, 63 subjects 
per group (a total of 126 patients) are needed. Correcting for 10% drop out, 70 patients in each group 
will be included. 
 
 
5. TREATMENT OF SUBJECTS 
5.1 Investigational product/treatment 
Patients are informed about the video consultation study by their physician during their first face-to-
face consultation in the hospital, after they received their treatment plan. After this consultation the 
researcher will provide patients with additional information and, if asked for, answer questions. 
Because of clinical necessity patients have to start treatment the same day and therefore the 
researcher will ask patients for their informed consent and to fill in the baseline questionnaire 
(approximately 20 minutes) in the hospital. After that, patients will be randomized by the researcher 

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using the software program ‘research manager’. Participants in the intervention group are also 
provided with information to install the video consultation system – using FaceTalk –  at home (see 
Appendix 2 for specifications). If necessary, they can call a researcher for support. Two days after the 
start all participants will have a consultation by telephone and approximately 1 week after start with 
CPAP the participants in the intervention group will have a video consultation planned and the 
controlled group a face-to-face consultation (with a nurse). Three focus points will be discussed during 
the consultations: (1) adherence (> 6 hours per night); (2) rest AHI <5 (or <10 if age >70); and (3) 
improvements or complaints. As long as these objectives are not achieved a video consultation will be 
planned weekly for the intervention group and face-to-face consults in the control group. If the 
objectives are achieved one week after start with CPAP, a video consultation will be planned four 
weeks later. See appendix I for the total CPAP treatment process. 
 
5.2 Use of co-intervention (if applicable) 
NA 
 
5.3 Escape medication (if applicable) 
NA 
 
6. INVESTIGATIONAL PRODUCT  
NA 
  
7. NON-INVESTIGATIONAL PRODUCT 
NA 
 
 
8. METHODS 
8.1 Study parameters/endpoints 
8.1.1 
Main study parameter 
8.1.1.1 Use (minutes/per night) 
CPAP use will be measured with Encore anywhere (Philips) and information will be obtained from the 
Electronic Medical Record.  
8.1.2 
Secondary study parameters/endpoints (if applicable) 
8.1.2.1 Treatment self-efficacy (SEMSA subscale) 
Self-efficacy is a subscale of the Self-Efficacy Measure for Sleep Apnea (SEMSA).The SEMSA is a 
26-item scale and indicated good psychometric properties with reported internal consistency 
(Cronbach’s alpha = 0.92) and test-retest reliability (0.68) [24]. The subscale self-efficacy consists of 9 
questions including “I would use CPAP…if have to wear a tight mask” and “I would use CPA…if it 

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disturbed my partner”. These items will be rated on a 4-point scale ranging from not at all try – very 
true. A sum score for this subscale will be calculated by taking the mean score of the nine items.  
 
 
8.1.2.1 Risk perception (SEMSA subscale) 
Risk perception is a subscale of the Self-Efficacy Measure for Sleep Apnea [24], and consists of 8 
questions, for example “having OSA, my chances of falling asleep driving” and “having OSA my 
chances of difficulty concentrating”. These items will be rated on a 4-point scale ranging from “very low 
to very high”. A sum score for this subscale will be calculated by taking the mean score of the eight 
items.  
 
8.1.2.2 Outcome expectancies (SEMSA subscale) 
Outcome expectancies will be measured, which is a subscale of the Self-Efficacy Measure for Sleep 
Apnea [24], and consists of 9 items for example “If I use CPAP…I will be more active”. These items 
will be rated by a 4-point scale ranging from “not at all true – very true.” A sum score for this subscale 
will be calculated by taking the mean score of the eight items.  
 
8.1.2.3 Adherence  
Adherence will be measured with Encore anywhere (Philips) and information will be obtained from the 
Electronic Medical Record. Adherence for CPAP use is defined as using CPAP at least seven nights a 
week for at least six hours a night, according to the protocol in Rijnstate hospital.  
 
8.1.2.4 Expectations and experiences – according to constructs of the UTAUT model 
Questions covering constructs of the Unified Theory of Acceptance and Use of Technology (UTAUT) 
model will be used to measure expectations and experiences of use of the video consultation system. 
The UTAUT consist of four constructs that influence behavioral intention and behavior: (1) 
performance expectancy, (2) effort expectancy, (3) social influence, (4) facilitating conditions [26]. 
Eight items will be rated on a seven point scale. Results will be presented as mean and standard 
deviation (SD). 
 
8.1.2.5 Satisfaction 
All patients will be asked to fill in a questionnaire assessing effects on satisfaction with the video 
consultation system (for the intervention group only) and patient-professional communication. 
 
Healthcare professionals will also be asked to fill in a questionnaire, after patients’ treatment, 
measuring effects on:  
• 
Experiences with the system; 
• 
satisfaction  
• 
organizational benefits (e.g. time, efficiency of work processes) 

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8.1.3 
Other study parameters (if applicable) 
The patients’ age, marital status, education, experience with internet and internet use, 
tablet/smartphone skills and support (with tablet/smartphone use) will be assessed via a 
questionnaire. We will also use information from the Electronic Medical Record about patients’ daytime 
sleepiness (results from the Epworth Sleepiness Scale), comorbidities, (re)admissions to the hospital 
and emergency room visits. 
 
 
8.2 Randomisation, blinding and treatment allocation 
8.2.1 
Randomization 
The researcher will randomize participants to the intervention or control group using the software 
program ‘research manager’. 
8.2.2 
Blinding 
Health care professionals (pulmonologists and nurses) and the researcher are not blinded to the 
participants intervention group.  
8.2.3 
Treatment allocation 
In total, n=140 patients will be randomized. All patients diagnosed with sleep apnea that will be treated 
with CPAP will be informed about the study. Patients will be included in the study when they meet the 
inclusion criteria and agree to participate.  
 
8.3 Study procedures  
Patients receive a letter from the hospital about their appointments (eg sleep study and consultation 
with the doctor or nurse practitioner). Patients will receive information about the video consultation 
study together with this letter. 
 
Patients are also informed about the video consultation study by their physician during their face-to-
face consultation in the hospital. After this consultation the researcher will provide patients with 
additional information and, if asked for, answer questions. Because of clinical necessity patients have 
to start treatment the same day and therefore the researcher will ask patients for their informed 
consent and to fill in the baseline questionnaire (approximately 20 minutes) in the hospital. After that, 
patients will be randomized. Participants in the intervention group are also provided with information 
about how to install the video consultation system at home. Two days after the start all participants will 
have a consultation by telephone and approximately 1 week after start with CPAP the participants in 
the intervention group will have a video consultation planned and the controlled group a face-to-face 
consult. Three focus points will be discussed during the consults: (1) adherence (> 6 hours per night); 
(2) rest AHI <5 (or <10 if age >70); and (3) improvements or complaints. As long as these objectives 
are not achieved a video consultation will be planned weekly for the intervention group and face-to-

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face consultations in the control group. If the objectives are achieved one week after start with CPAP, 
a video consultation will be planned four weeks later. See appendix I for the CPAP treatment process. 
 
8.4 Withdrawal of individual subjects 
Patients can leave the study at any time for any reason if they wish to do so without any 
consequences. The investigator can decide to withdraw a patient from the study for urgent medical 
reasons. 
 
8.4.1 
Specific criteria for withdrawal (if applicable) 
NA 
 
8.5 Replacement of individual subjects after withdrawal 
Subjects will not be replaced after withdrawal. 
 
8.6 Follow-up of subjects withdrawn from treatment 
NA 
 
8.7 Premature termination of the study 
NA 
 
 
9. SAFETY REPORTING 
It is not expected that this study will jeopardize subject health or safety or will result in adverse effects.   
 
 
10. STATISTICAL ANALYSIS 
10.1 Primary study parameter(s) – CPAP use (minutes/per night) 
Use will be reported after week 1, week 2, week 3 and week 4 using descriptive statistics (mean and 
SD). Difference in use between the two groups will be tested after 4 weeks using independent 
samples t-test. Also difference in use between the two groups after week 1, week 2, week 3 and week 
4 will be tested using mixed-model analyses. 
 
10.2 Secondary study parameter(s) – self-efficacy (SEMSA subscale), perceived risk 
(SEMSA subscale), outcome expectancies (SEMSA subscale), adherence, 
expectations and experiences and satisfaction 
Difference in the variables of the parameters “self-efficacy”, “perceived risk”, “outcome expectancies” 
and “satisfaction” between the two groups will be tested after 4 weeks using independent samples t-

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test. Difference in adherence rates will be tested by Chi-square analyses. The analyses will be 
conducted according to the intention-to-treat principle. “Experiences” and “expectations will be will be 
presented as mean and standard deviation (SD).  
 
10.3 Other study parameters 
Descriptive statistics (frequencies, percentages, means, standard deviations) will be used to present 
sociodemographic variables and differences at baseline will be tested by relevant statistic (t-test or chi 
square depending on the type of outcome variable). 
 
10.4 Interim analysis (if applicable) 
NA 
 
10.5 Missing data 
If the missing values are more than 10% we will use multiple imputation analyses. 
 
11. ETHICAL CONSIDERATIONS 
11.1 Regulation statement 
This study will be conducted in accordance with the principles of the Declaration of Helsinki (version 
10, amended in October 2013 by the 64th WMA General Assembly) and in accordance with the 
Medical Research Involving Human Patients Act (WMO) and this research protocol. The handling of 
personal data will be in accordance with the Dutch Personal Data Protection Act (In Dutch: Wet 
Bescherming Persoonsgegevens (WPB)). 
 
11.2 Recruitment and consent 
During their first consultation with the pulmonologist, patients are informed about their treatment with 
CPAP. Because of clinical necessity patients have to start treatment the same day. When patients are 
eligible they will receive written information about the study during their first consultation from their 
treating physician. Subsequently, a researcher will provide patients with further information about the 
study. Patients will be asked to participate and sign the informed consent form. After consent and 
randomization the participants will receive additional information, if applicable, about the video 
consultation system.  
 
11.3 Objection by minors or incapacitated subjects (if applicable) 
NA 
 
11.4 Benefits and risks assessment, group relatedness 
NA 

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11.5 Compensation for injury 
Dispensation for the insurance obligation. 
 
11.6 Incentives (if applicable) 
NA 
 
12. ADMINISTRATIVE ASPECTS, MONITORING AND PUBLICATION 
12.1 Handling and storage of data and documents 
Data will be handled confidentially. A subject identification code list will be used to link the data to the 
subject. The key code will be safeguarded by the investigator (Laura Kooij) and will be saved on a 
computer in the work office at Rijnstate hospital. The data will be coded using numbers in order 
enrolment, 1 / 2 / 3 etc. The intervention group will be added as a fixed code A and the control group 
as B. The first enrolled patient of the intervention group will be coded as A1, the second as A2. The 
first enrolled patient of the control group will be coded as B1, the second as B2. The investigators 
Laura Kooij and the pulmonologists P.J.E. Vos, MD, PhD and A. Dijkstra, MD will have access to the 
source data. Data will be stored for at least 15 years in an office at Rijnstate hospital. 
 
12.2 Monitoring and Quality Assurance  
Internal monitoring will take place once within three months after the start of inclusion and once after 
patient inclusion is finished. Monitoring will be handled by the monitoring coordinator in Rijnstate 
hospital. All data will be checked for anonymity, completeness and accuracy. 
 
12.3 Amendments  
Amendments are changes made to the research after a favorable opinion by the accredited METC has 
been given. All amendments will be notified to the METC that gave a favorable opinion.  
 
All substantial amendments will be notified to the METC and to the competent authority. 
 
Non-substantial amendments will not be notified to the accredited METC and the competent authority, 
but will be recorded and filed by the sponsor.  
 
12.4 Annual progress report 
This study will run for six months and therefore a report will be delivered at the end of the study period. 
 

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12.5 Temporary halt and (prematurely) end of study report 
The investigator will notify the accredited METC of the end of the study within a period of 8 weeks. The 
end of the study is defined as the last patient’s received follow-up questionnaire. 
 
Within one year after the end of the study, the investigator will submit a final study report with the 
results of the study, including any publications/abstracts of the study, to the accredited METC. 
 
12.6 Public disclosure and publication policy 
The investigators will publish the results of the study as soon as appropriate. 
 
13. STRUCTURED RISK ANALYSIS  
We used the risk analysis provided by Rijnstate. The use of this checklist resulted of the classification 
of the risk of this study as ‘little’. Because the estimated change for damage is ‘little’, the level of 
severity of the damage is ‘light’ and there is no vulnerable population include in the study. 
 
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box. Sleep medicine clinics, 2016. 11(4): p. 445-459. 
22. 
Smith, C.E., et al., Telehealth services to improve nonadherence: a placebo-controlled study. 
Telemedicine Journal & e-Health, 2006. 12(3): p. 289-296. 
23. 
Isetta, V., et al., A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for 
the management of sleep apnoea: a multicentre randomised controlled trial. Thorax, 2015: p. 
thoraxjnl-2015-207032. 
24. 
Weaver, T.E., et al., Self-efficacy in sleep apnea: instrument development and patient 
perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous 
positive airway pressure. Sleep, 2003. 26(6): p. 727-32. 
25. 
Parthasarathy, S., et al., A pilot study of CPAP adherence promotion by peer buddies with 
sleep apnea. Journal of Clinical Sleep Medicine, 2013. 9(06): p. 543-550. 
26. 
Venkatesh, V., et al., User acceptance of information technology: Toward a unified view. MIS 
quarterly, 2003: p. 425-478. 
27. 
Facetalk. Veelgestelde vragen. 2015  [cited 2018 23-05]; Available from: 
https://facetalk.nl/faq/#veiligheid. 
 
 
 
 
 
 
 
 
 
 
 
 

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16 
 
 
 
 
 
 
Appendix 1 – Study process 
 
New patient - Day 1
• Face-to-face consult 
• Baseline questionnaire
Consult by phone
2 days after start – Nurse practitioner
Note: 1) Adherence hours, 2) Rest 
AHI, 3) Mask leakage, 4) Rest 
complaints
Video consult
1 week after start - OSA nurse 
Focus points/objectives: 1) Adherence 
(> 6 hours per night); 2) Rest AHI <5 
(or < 10 if age >70); 3) Improvements 
of complaints
Video consult 
1 week after start and 
weekly - OSA nurse
Until three objectives are 
achieved
NOT achieved
Video consult
After 4 weeks – OSA nurse
To check if objectives are 
still achieved.
Consult pulmonologist
After 4 weeks if objectives 
are NOT achieved: contact 
with pulmonologist and 
reassessment
Intervention group
Control group 
Start CPAP
Achieved
Questionnaire (post)
Randomisation
Randomisation
Consult by phone
2 days after start – Nurse practitioner
Note: 1) Adherence hours, 2) Rest 
AHI, 3) Mask leakage, 4) Rest 
complaints
Face-to-face consult
1 week after start - OSA nurse 
Focus points/objectives: 1) Adherence 
(> 6 hours per night); 2) Rest AHI <5 
(or < 10 if age >70); 3) Improvements 
of complaints
Face-to-face consult 
1 week after start and 
weekly - OSA nurse
Until three objectives are 
achieved
Face-to-face consult
After 4 weeks – OSA nurse
To check if objectives are 
still achieved.
NOT achieved
Achieved
Consult pulmonologist
After 4 weeks if objectives 
are NOT achieved: contact 
with pulmonologist and 
reassessment
Questionnaire (post)
 
 
 
 

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Appendix 2 – FaceTalk specifications 
 
Facetalk 
Facetalk will be used in this study in hospital to enable video consultations with patients. This product 
is approved by the Information and Medical Technology department (IMT). 
 
Information security 
This service complies with the NEN 7510/NEN 7512 standards concerning information security in 
health care [27]. 
 
Requirements for using Facetalk (for patients) 
• 
Tablets (Apple and Android) and smartphones (Apple and Android) with a (integrated) 
webcam, (integrated) speakers, (integrated) microphone and a working internet connection.  
• 
Facetalks makes use of a “browser plug-in”. Chrome, Firefox, Internet Explorer and Safari can 
be used. Patients need to accept the browser-plug in before their first use. If patients want to 
use FaceTalk with iOS and Android it is necessary to download and install the free app 
“Vidyo” [27].