Identifying Aspects of Patient Acceptance based on a Preliminary Clinical Trial
Rune Fensli
and Egil Boisen
Faculty of Engineering and Science, University of Agder, Grimstad, Norway
Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
Keywords: Quality of life, Patient Acceptance of Health Care, Ambulatory Monitoring, Telehomecare, Usability.
Abstract: In this paper, we highlight some important aspects of how to evaluate patient acceptance with wearable
sensors recording vital signs information, used in a telehomecare environment. Questions of human factors
and patient satisfaction need to be addressed, where the patient is able to carry out daily life activities in his
own environment. We compare results from a preliminary clinical trial with patients using a wireless ECG
sensor for three days out-of-hospital service, to available published results from telehomecare projects, and
propose important aspects and plans for future investigations. It is important not only to observe the patient,
but also the possible changes in the family situation when a sick patient is transferred to his own home for
active treatment. At the same time, emotional barriers and stigmatisation are challenging factors where time
is needed to let the patient adopt this new situation. Therefore, measures should be on an on-going basis
with long-term use of the technological equipment in order for the patient to integrate this into his body
scheme as well as daily activities. Of special importance will be the evaluation of the communication be-
tween the patient and the health professionals, as quick feedback from the doctor to the patient on his or her
own measurements is of outmost importance.
Several research projects have been focusing on
wearable biomedical sensors and their benefits for
ambient assisted living, where the patients are re-
motely monitored by different sensors placed on the
body for vital signs recording (Jones et al., 2006).
However, little efforts have been done investigating
how the patients experience and manage this new
Chronically ill patients experience a greater de-
gree of freedom and are more involved in the treat-
ment with daily monitoring of vital information
during hospitalization in their own home, than with
the traditional treatment procedures at hospital. In-
troducing advanced medical technology in the pa-
tient’s own home will influence the patient’s situa-
tion as it makes empowerment and self-management
possible (Barlow et al., 2002).
At the same time, coordinated follow-up and new
workflow procedures for the health-care services
need to be implemented in order to give the patient
satisfactory support by virtual visits in his home
(Wootton and Kvedar, 2006). However, this support
also must be integrated in the self-monitoring of
vital signs information performed by the patients,
with understandable interpretations of the results.
The primary goal of developing wireless ECG
sensors is to find ways of monitoring the everyday
life of the patient as closely as possible. In other
words, the rationale is to increase the quality of data
being collected by decreasing the impact on the
patient’s everyday life when he or she is being moni-
tored. When implementing such equipment it is
therefore necessary to allow the patient to integrate
it into his or her daily activities. Also, we argue that
this integration concerns a person’s body scheme,
being a dynamic, and typically unaware, representa-
tion of the positions of one’s body parts (Haggard
and Wolpert, 2005). To monitor this process, meas-
ures should therefore be based on long-term use of
the wireless equipment in an everyday life situation.
In this paper we will focus on how the technol-
ogy acceptance can be monitored in order to high-
light obstacles and possible improvements both in
Fensli R. and Boisen E. (2008).
Preliminary Clinical Trial.
In Proceedings of the First International Conference on Health Informatics, pages 3-8
the technology solutions and in coordination with
the health care services. Based on experiences from
a preliminary clinical trial, we try to identify some
important aspects of patient acceptance and present
plans for future projects involving observations of
user acceptance.
1.1 Usability and Telehomecare
Home telehealth is a growing field of patient treat-
ment and follow-up, but most research studies have
focused on the technology, and so questions of hu-
man factors and patient satisfaction need to be ad-
dressed. A systematic review of studies of patient
satisfaction with telemedicine was done by Mair and
Whitten, arguing that “available research fails to
provide satisfactory explanations of the underlying
reasons for patient satisfaction or dissatisfaction
with telemedicine”. They found that the studies
concerning patient satisfaction mainly used simple
survey instruments and that many of the studies had
only a few participants (Mair and Whitten, 2000).
According to Friedman & Wyatt, usability stud-
ies can be useful in the evaluation of new biomedical
equipment, with the aim of observing speed of use,
user comments and completion of simple tasks
(Friedman and Wyatt, 2006). They describe field
function studies as useful in the validation of proto-
types or released versions of new biomedical equip-
ments, but the trials should be conducted in situa-
tions with real use of the equipment, and with the
aim of observing speed and quality of data collected
and accuracy of advice given from the devices.
The principles of user-centered design can be
useful when designing new telehomecare devices.
Adlam and colleagues describe how user evaluation
can be implemented in the design process (Adlam et
al., 2006). They start with discovering the “real
problem” and the users’ requirements, which can be
accomplished with a simple prototype demonstrating
the actual functionality of a device. However, inter-
acting with real users in their own environments will
be a challenging task, and protypes with limited
functionality can give restrictions on the use of the
new solution to be developed, resulting in prelimi-
nary tests, which do not reflect a more complicated
use situation, i.e. the daily activities of the patients.
Kaufmann and colleagues developed a system
design for both usability testing and usability inspec-
tion in the patient’s home for a diabetes telemedicine
system. First, they used a cognitive walkthrough to
identify goals and sequences of actions to anticipate
potential user problems. Second, a field usability
testing was performed as a series of tasks to be ac-
complished by the subjects in their home and closely
followed by semi-structured interviews to reveal
problems and barriers to efficient and safe use of the
system (Kaufmann et al., 2003). A similar approach
has been suggested by Kushniruk and Patel, who
have developed a low-cost portable usability testing
solution intended to be used by patients in their
homes (Kushniruk and Patel, 2004).
In a study of the patient’s perspectives on high-
tech homecare technology, Lehoux found that the
user-acceptance was shaped by different types of
anxiety, which mainly was related to the actual
equipment and the procedures. At the same time, the
patients complained of reductions in daily activities
as well as feelings of stigmatization, as they tended
to withdraw from social activities in order to hide
the medical equipment from the eyes of visitors. For
a patient wearing a permanent catheter, this will alter
the patient’s body image (Lehoux, 2004). Lehoux
found that good usability is dependant on compe-
tence, where lay people are supposed to use high-
tech medical devices, as well as on technical and
human dimensions, where the technology is inte-
grated into the patients’ private and social lives.
Hopp and colleagues measured the outcome for
patients receiving telehealth home-care and used a
questionnaire at baseline and after six months, where
they used a modified version of the SF-36 to meas-
ure Health Related Quality Of Life (HRQOL) (Hopp
et al., 2006). In addition they used separate questions
to ask about satisfaction with the telehealth equip-
ment for the intervention group, with questions from
the National Ambulatory Care Survey and modified
for use in evaluating telehealth services. They found
a high degree of satisfaction with the telemedicine
equipment, but few patients reported that their fam-
ily members had been taught how to use the equip-
ment installed in their homes.
In this paper, we present some ideas of how to
evaluate human aspects of telehomecare solutions,
which are based on preliminary results from a clini-
cal study where patients have used wearable sensors
for a three day period of out-of-hospital service. We
focus on the impact on everyday life during the
patients’ use of the wireless ECG-sensor; the experi-
ences with daily behaviour as well as general patient
satisfaction. The important question is which factors
to include in future evaluations, and how to observe
the degree of the patients’ influence on new tele-
homecare services, together with their perception
HEALTHINF 2008 - International Conference on Health Informatics
and possible adoption of the new technology.
Patients referred to long-term ambulatory “Holter”
arrhythmia procedures at the outpatient clinic at
Sørlandet Sykehus HF in Arendal, Norway, were
asked to participate in a study wearing our newly
developed wireless ECG-sensor (Fensli et al., 2005).
By signing the informed consent form, they partici-
pated in the study during their ordinary arrhythmia
investigation. The inclusion criteria was patients
with suspected arrhythmias, and the exclusion crite-
ria was patients with dementia who were anticipated
not being able to handle the equipment and contrib-
ute in filling out the required questionnaires.
After signing the informed consent form, the pa-
tients were given information of the research project
and they received several questionnaires to be filled
in during the time they used the wireless ECG-
system as a usability study. Because influences from
participating in a three day trial of the new recording
solutions can be a bias in the evaluation of patient
acceptance, a reference group with patients undergo-
ing a “normal” routine investigation at the hospital
using conventional “Holter” monitoring equipment
(Huntleigh Healthcare) was established.
During the period from November 2006 to May
2007, 11 patients were enrolled in the study, and 25
patients were included in the reference group. The
questionnaires focused on several topics, among
them questions defining the Dimensions: Hygienic
Aspects (3 items), Physical Activity (6 items), Skin
Reactions (2 items), Anxiety (3 items), and Equip-
ment (5 items) (Fensli et al., 2008). After a three day
period of arrhythmia investigation with the use of
the wireless sensor, 4 patients in the intervention
group were followed-up with qualitative interviews,
in order to discover more general experience with
regard to the use of a wearable sensor.
In the questionnaire, the patients are asked about
their experiences with the use of the equipment,
where we have used an 11-point semantic differen-
tial scale. The patients should evaluate their experi-
ence of using the wireless equipment in terms of
their agreement to the statements describing actual
situations of the equipment usage. For some of the
questions the scale was ranging from “0 – Extremely
problematic” to “10 – Without any problems”. Some
items described a statement with scale values rang-
ing from “0 – I completely disagree” to “10 – I com-
pletely agree”. In addition, they filled in some gen-
eral characteristics, such as gender and age. The
results are given in Table 1.
Table 1: Patients’ general characteristics and results from
the calculated dimensions based on the questionnaires,
Mean (SD). Calculations of Cronbach’s alpha for the
dimension Hygienic Aspects was 0.83, for Physical Activ-
ity 0.88, for Skin Reactions 0.65, for Anxiety 0.80 and for
Equipment 0.86.
General characteristics
and Dimensions
Gender: Man/woman 6 / 5 7 / 18
Age 40.2 (19.4) 56.4 (13.2)
SAI 8.2 (1.0) 7.6 (1.9)
Hygienic Aspects 8.6 (1.6) 6.6 (2.9)
Physical Activity 9.2 (0.8) 8.0 (2.8)
Skin Reactions 6.3 (2.5) 8.6 (2.4)
Anxiety 9.0 (1.3) 7.3 (3.5)
Equipment 8.0 (1.7) 7.5 (2.8)
* significant difference p<.05
The internal consistency, as calculated by Cron-
bach’s alpha, showed acceptable levels. The con-
struct validity was evaluated by confirmatory factor
analysis, giving reasonable factor loading according
to our expectations. Calculations of a Sensor Accep-
tance Index (SAI) as an aggregated score showed a
tendency towards a higher score for the wireless
group compared to the reference group; however this
difference was not at a significant level. For the
dimension Hygienic Aspects regression analyses
showed a significant difference between the two
groups (F (1,34)=4.51; p<0.05), with a higher score
for the wireless group. The dimension Skin Reac-
tions showed a significantly higher score for the
reference group (F (1,31)=5.95; p<0.05). With re-
gard to the dimensions Anxiety and Physical Activ-
ity, the wireless sensor showed higher scores; how-
ever, this was not a significant difference.
In the interviews with four of the patients in the
intervention group, we tried to discover some gen-
eral experiences from the patients’ use of the wire-
less recording equipment. All patients reported some
anxiety because of what they found to be a degree of
uncertainty, as they did not receive any feedback
from the recording system of the measurements
made. They expected a quick feedback from the
hospital, and two of the patients expressed the need
for patient influence, while one of the respondents
of Patient Acceptance based on a Preliminary Clinical Trial
said that he was not concerned with influence.
The hygienic factor focused on actual tasks re-
lated to the patient’s ability to perform body wash
and use of the equipment during the night while
asleep, in order to obtain information about any
problems relating to the wearable recording sensor.
The survey showed a significant difference for the
hygienic aspects, and the wireless solution obviously
was preferable, since it is easy to wear and does not
involve any hindrances like cables. This was con-
firmed both by responses to the open questions in
the questionnaire and by statements in the inter-
views, as the patients generally expressed high satis-
faction with the wireless solution compared to the
existing “Holter” system. They felt free to carry out
daily activities without any hindrance.
With respect to the equipment used, one patient
complained about the “Holter” recorder, and said
that he had “a feeling of being a living medical in-
strument”, because of all the cables he had to wear.
With regard to the wireless sensor, he said: “The
wireless sensor was comfortable to wear, and most
of the time I just forgot I was wearing this system”.
He said that the sensor after a while became “a part
of me”.
Another patient said the wireless system made it
possible for her to participate in physical exercise. It
was much easier to wear, especially during the night,
and it did not prevent her from being able to take a
shower. The Holter equipment was troublesome with
all the cables, and made the hygienic activities more
problematic. In her view, the differences in use be-
tween those two systems were huge, and they can
not be compared at all.
One of the patients expressed some dissatisfac-
tion with wearing this equipment, and she wanted to
hide the equipment from other people. Similar ex-
pressions of embarrassment were also found in re-
sponses to the open questions in the questionnaire,
and even if the calculated difference was not at a
significant level, it showed a trend toward more
anxiety regarding the use of the Holter equipment.
The results presented above are of interest in the
evaluation of patient experience with wearable sen-
sors attached to the chest for three days of continu-
ous monitoring. Even though this clinical trial was
limited both in terms of time and the number of
patients, some interesting aspects have been discov-
ered in relation to integration into the patients’ eve-
ryday life. By comparing results and experiences
from the clinical trial with available published re-
sults from other telehomecare projects, it has been
possible to discover some general aspects and point
out ideas for future investigations.
First, our findings point to the issue of stigmati-
zation, as some patients wish to hide the wireless
recorder from the eyes of other people. This was
similar to the findings by Myers et al., who studied
the impact of home-based monitoring on patients
with congestive heart failure, and followed up pa-
tients for a 2 month period. They found it necessary
to train patients in telemonitoring procedures on an
ongoing basis (Myers et al., 2006). During their
study, 13.5% of patients withdrew due to anxiety or
because they did not “like” the telemonitoring pro-
cedures or equipment. Their experiences of patient
perception and ability to learn how to use the
equipment indicate that the emotional barriers and
stigmatization were a challenging factor and time
was needed to allow the patients to adapt to this new
situation. Our findings, however, also showed that
when patients feel like the sensor is becoming “a
part of me”, as expressed by one of the patients, the
stigmatization factor does not seem to represent any
problems for the patient during daily activities, and
can be adopted within his or her body scheme.
Second, our findings point to a need of constant
feedback from the system or the health professionals
to the patients. In this study we did not implement a
daily reporting schema between the patient and the
hospital, which was probably the reason why the
patients expressed some worries about what the
technology was measuring in terms of irregularities
in their heart beats. Even though they trusted the
equipment, they would like to see the results and the
doctor’s evaluation of the results when they felt
irregular heart beats. These findings were in line
with our experiences from an earlier study where
patients underwent a 24-hour Holter recording pro-
cedure (Fensli et al., 2004), and quick feedback from
the doctor was evaluated to be of utmost importance.
However, although the patients appreciated good
information during the research project, they ex-
pressed some uncertainty with respect to from whom
they would receive an answer concerning arrhythmia
findings. Their misperception of the health care
sector as a “clear and strictly coordinated service”,
capable of giving them the desired follow-up, shows
that organizational issues will be of utmost impor-
tance when introducing new telemedical solutions. If
the co-ordination within the health care sector is not
clearly defined, questions from the patients will not
be correctly addressed and there will easily be situa-
tions where patients will suffer from not having
HEALTHINF 2008 - International Conference on Health Informatics
received the required feedback to the situation at
Third, during the interviews the patients ex-
pressed overall good confidence with using the
wearable sensor, mostly because of the ease of use
during daily activities, which was confirmed by the
significant difference calculated for the Hygienic
Aspects. As a general measure of satisfaction (SAI),
we found a relatively high score at 8.2 for the inter-
vention group and 7.6 for the reference group. Ac-
cording to the intentions of home-based health care
as expressed by Barlow and colleagues, those ex-
pressions of satisfaction were somewhat as expected
(Barlow et al., 2002). This has also been confirmed
by Whitten and Mickus in their study of patients
with congestive heart failure in addition to chronic
pulmonary disease, finding that the patients were
satisfied with the technology (Whitten and Mickus,
2007). Wootton and Kvedar have also pointed to the
importance of changes in the health care services
(Wootton and Kvedar, 2006), and their findings are
also in line with what was reported by Scalvini and
colleagues in their study of chronic heart patients
and the effects of home-based telecardiololgy (Scal-
vini et al., 2005). In our study, the scores for Anxi-
ety were relatively high indicating a low degree of
anxiety, with 9.0 in the intervention group and 7.3 in
the reference group. The age of patients in the refer-
ence group was slightly higher and consisted of
more female patients, which may represent a bias.
However, being confident with using the wearable
equipment combined with a feeling of safety is im-
portant to the patients.
Patient acceptance of home hospitalization
equipment on a long-term basis does not seem to
have been given the necessary attention in previous
studies of telehomecare. Following a systematic
study of observed effects in home telemonitoring of
patients with diabetes, Jaana and colleagues found
that studies should be extended in time and involve
larger samples of patients in order to generalize the
findings and obtain sufficient validity (Jaana and
Pare, 2007). Long-term evaluation may probably
also discover some underlying reasons for the feel-
ings of anxiety as reported by Lehoux.
We therefore propose future studies to follow the
patients’ use of wearable sensors and telehomecare
equipment for a relatively long time in order for the
patient to adopt the technology into his/her daily
activities and body scheme. Attention should be paid
to the patients’ ability to carry out hygienic activities
such as body wash or even taking a shower, and it
should be possible to participate in physical sports
activities while using wearable sensor recorders.
Also, not only the patient but also his/her spouse
or partner should be taken into account and given the
necessary information about how the treatment
should be performed and how to interact with the
health care services in a coordinated manner using
tele-medical equipment. As proposed by Kushniruk
and Patel, multi-method evaluations can be impor-
tant, and even the use of video-recording can be
performed in the patients’ home (Kushniruk and
Patel, 2004). Hence, a multi-method approach can
be employed, where questionnaires can provide
some background information about the patients,
their behaviour, and acceptance of the technology. In
addition, interviews in the patient’s home can be
combined with video recordings and, later on, analy-
sis of the process data to obtain a more thorough
understanding of obstacles and barriers to the use of
such solutions. Evaluating the communication be-
tween the patient and health care services will also
be of special importance, and new e-health-based
forms of communication should be investigated. As
quick responses are required by the patients, quality
factors in the communication between the patient
and the health care service should be observed.
Implementation of wireless sensors for vital signs
recording for the use in home hospitalization can be
a great benefit for the patient, as this gives a feeling
of freedom compared to ordinary hospital stay. Dur-
ing the use of wireless ECG-sensors, the patients in
this study were satisfied with the ease of use in a
daily life situation, and gave a higher score in the
factor Hygienic Aspects than patients in the refer-
ence group. With respect to the factor Anxiety no
significant differences were discovered. However,
the use of wearable medical equipment can also
affect the patients’ everyday life situation in a nega-
tive manner, where they tended to hide the equip-
ment from the eyes of other people, and they ex-
pressed anxiousness for not using the telemedical
equipment in a correct manner. But at the same time,
the patients also expressed confidence with the sys-
tem and tended to adopt its use into their daily life.
During the interviews, the patients, however, ex-
pressed worries of not having immediate feedback
and responses to irregular heart beats, and their ex-
pectations of instant follow-up by the health care
sector were revealed. This can be a great challenge
where necessary coordinated routines and workflow
within the health care sector should be defined and
established before implementing new telemedical
of Patient Acceptance based on a Preliminary Clinical Trial
services. The feedback channels to the patients’
questions and recordings should be timely defined
and validated. In order to investigate the use of
telemedical technology in everyday life situations,
research studies should be performed in a relatively
long-term manner. Also, by employing a multi-
method approach, such studies should focus on ob-
serving to which degree the patient adopts this new
technology into his or her everyday life as well as
body scheme or body image. Additionally, such
studies should take into account the interaction be-
tween the patient and the system, as well as the in-
teraction between the patient and the health care
professionals. Finally, it seems necessary to also
investigate how the patient’s partner or spouse ex-
periences the technology in daily use.
The study is supported by the Research Council of
Norway. The clinical trials are done in close co-
operation with Sørlandet Sykehus HF, Arendal and
the company WPR Medical AS. The authors thank
Torstein Gundersen, Ellen Ytrehus and Åse Løs-
nesløkken at Sørlandet Sykehus, and Eirik Aanonsen
at WPR Medical for good assistance with the pa-
tients during clinical trials. We also thank Kjersti
Nag, Hjørdis Løvdal Gulseth and Hedda Løvland for
their assistance with interviewing the patients.
Adlam, T., Orpwood, R. & Dunn, T., 2006. User evalua-
tion in pervasive healthcare. IN BARDRAM, J. E.,
MIHAILIDIS, A. & WAN, D. (Eds.) Pervasive Com-
puting in Healthcare. CRC Press, Inc. Boca Raton,
Barlow, J., Wright, C., Sheasby, J., Turner, A. & Hains-
worth, J., 2002. Self-management approaches for peo-
ple with chronic conditions: a review. Patient Educ
Couns, 48, 177-87.
Fensli, R., Gundersen, T. & Gunnarson, E., 2004. Design
Requirements for Long-Time ECG recordings in a
Tele-Home-Care Situation, A Survey Study. Scandi-
navian Conference in Health Informatics. Arendal,
Fensli, R., Gunnarson, E. & Gundersen, T., 2005. A
Wearable ECG-recording System for Continuous Ar-
rhythmia Monitoring in a Wireless Tele-Home-Care
Situation. The 18th IEEE International Symposium on
Computer-Based Medical Systems. Proceedings ed.
Dublin, Ireland, IEEE CNF.
Fensli, R., Pedersen, P. E., Gundersen, T. & Hejlesen, O.,
2008. Sensor Acceptance Model - Measuring Patient
Acceptance of Wearable Sensors. Methods of Informa-
tion in Medicine, Accepted for publication.
Friedman, C. P. & Wyatt, J. C., 2006. Evaluation Methods
in Biomedical Informatics, Springer-Verlag.
Haggard, P. & Wolpert, D. M., 2005. Disorders of body
schema. IN FREUND, H.-J. (Ed.) Higher-order Motor
Disorders: From Neuroanatomy and Neurobiology to
Clinical Neurology. NY, Oxford University Press.
Hopp, F., Woodbridge, P., Subramanian, U., Copeland, L.,
Smith, D. & Lowery, J., 2006. Outcomes associated
with a home care telehealth intervention. Telemedicine
Journal and E-Health, 12, 297-307.
Huntleigh Healthcare, Medilog AR4 Digital Holter Re-
Jones, V., vanHaltern, A., Dokovsky, N., Koprinkov, G.,
Peuscher, J., Bults, R., Konstantas, D., Widya, I. &
Herzog, R., 2006. Mobihealth: Mobile Health Services
based on Body Area Networks. IN ISTEPANIAN, R.
(Eds.) M-Health: Emerging Mobile Health Systems.
Jaana, M. & Pare, G., 2007. Home telemonitoring of
patients with diabetes: a systematic assessment of ob-
served effects. Journal of Evaluation in Clinical Prac-
tice, 13, 242-253.
Kaufmann, D. R., Patel, V. L., Hilliman, C., Morin, P. C.,
Pevzner, J., Weinstock, R. S., Goland, R., Shea, S. &
Starren, J., 2003. Usability in the real world: assessing
medical information technologies in patients´ homes.
Journal of Biomedical Informatics, 36, 45-60.
Kushniruk, A. W. & Patel, V. L., 2004. Cognitive and
usability engineering methods for the evaluation of
clinical information systems. Journal of Biomedical
37, 56-76.
Lehoux, P., 2004. Patients' perspectives on high-tech
home care: a qualitative inquiry into the user-
friendliness of four technologies. BMC Health Ser-
vices Research, 4, 28.
Mair, F. & Whitten, P., 2000. Systematic review of studies
of patient satisfaction with telemedicine. British Medi-
cal Journal, 320, 1517-1520.
Myers, S., Grant, R. W., Lugn, N. E., Holbert, B. & Kve-
dar, J. C., 2006. Impact of Home-Based Monitoring on
the Care of Patients with Congestive Heart Failure.
Home Health Care Management & Practice, 18, 444.
Scalvini, S., Capomolla, S., Zanelli, E., Benigno, M.,
Domenighini, D., Paletta, L., Glisenti, F. & Giordano,
A., 2005. Effect of home-based telecardiology on
chronic heart failure: costs and outcomes. Journal of
Telemedicine & Telecare, 11, 16-18.
Whitten, P. & Mickus, M., 2007. Home telecare for
COPD/CHF patients: outcomes and perceptions. J
Telemed Telecare, 13, 69-73.
Wootton, R. & Kvedar, J. C., 2006. Home Telehealth:
Connecting Care Within the Community, RSM Press.
HEALTHINF 2008 - International Conference on Health Informatics