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 treatment self-efficacy (primary outcome). Also the effects on risk perception, outcome…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is treatment self-efficacy, which 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). 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 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.
(See protocol - methods - main study parameter)
Secondary outcome
- Risk perception (SEMSA subscale)
Risk perception is a subscale of the Self-Efficacy Measure for Sleep Apnea
[22], 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.
- Outcome expectancies (SEMSA subscale)
Outcome expectancies will be measured, which is a subscale of the Self-Efficacy
Measure for Sleep Apnea [22], 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.
- 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.
- 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 consult 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 [23].
Eight items will be rated on a seven point scale. Results will be presented as
mean and standard deviation (SD).
- 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)
(See protocol)
Background summary
Obstructive Sleep Apnea (OSA) is a sleep disorder that affects at least 2% - 4%
of the adult population and is characterized by repeated episodes of full or
partial occlusion of the upper airway during sleep. OSA can be considered a
chronic disease and can have multiple effects on patients* health such as
cognitive dysfunction, a decrease in health-related quality of life, an
increase in cardiovascular disease risk and sleepiness during daytime.
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 and is
classified as mild (5-15 per hour), moderate (15-30 per hour) or severe (>30
per hour). Continuous Positive Airway Pressure (CPAP) is the treatment of
choice, especially for moderate to severe OSA. However, treatment adherence is
often problematic especially due to the discomfort of the mask and the machine.
As the effectiveness of CPAP is dependent on the use good adherence is
essential.
Participation of patients in their own treatment and support during treatment
can positively affect adherence. Patients often decide at an early stage of the
treatment process whether or not to use the CPAP machine, and this start can be
predictive of further use. Behavior change is considered a relevant factor for
CPAP use and treatment self-efficacy is an important predictor for behavior
change.
Video consultation is a useful way of supporting OSA patients during their
treatment and is a technology used to realize a real-time visual and audio
connection at a distance. Isetta et al. found that patients* knowledge after
receiving training about OSA and CPAP via video consult was comparable to the
knowledge of patients that received the same training face-to-face. They also
found patients to be positive about the use of video consultations. While
studies have evaluated the use of video consult for OSA patients and the
relation between patients* self-efficacy and CPAP adherence, few have examined
the effect of the use of video consultation on patients* self-efficacy during
CPAP treatment using a controlled design.
(See protocol - Introduction)
Study objective
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 treatment self-efficacy (primary outcome). Also the effects on risk
perception, outcome expectancy, CPAP adherence, video consult use (expectations
and experiences), and patients* and professionals* satisfaction will be
assessed (secondary outcomes).
(See protocol - objective)
Study design
The study will be a randomized controlled trial with an intervention group
(video consult) 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.
(See protocol - study design)
Intervention
Patients are informed about the video consult study by their physician during
their first face-to-face consult in the hospital. After this consult 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 consult 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 consult 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 consult will be planned four weeks later.
(See protocol - study procedures)
Study burden and risks
We used the risk analysis provided by Rijnstate. The use of this checklist
resulted of the classification 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.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
• diagnosed with moderate or severe sleep apnea AHI > 15
• patients will be treated with CPAP
• no history of CPAP treatment
• having (access to) a functional 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
Exclusion criteria
having a severe cognitive or psychiatric disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66192.091.18 |