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and vegetables, or “79” for a body weight of 79 kg).
All provided values are automatically saved in a
secure database for later evaluation.
At the end of their study participation (approx.
one month before the end), participants are
contacted by letter requesting them to fill in the final
questionnaires as far as possible (except for medical
data) and to bring them to their next appointment
with the attending neurologist. If participants need
support in completing the finalization
questionnaires, they are supported by an interviewer,
who also measures their blood pressure and heart
rate and fills in the required medical data. In
addition to the finalization questionnaires, which are
almost identical to the ones completed at the
beginning of the study (nutrition, physical activity
and quality of life), IC participants are asked to fill
in one additional form with questions concerning the
usability of the system and the user satisfaction. This
questionnaire encompasses the standardized System
Usability Scale (SUS) (Brooke, 1996) and a number
of system-specific questions, e.g. concerning the
system features (quality of the TTS voice, adequacy
of the automated feedback etc.), the preferred
frequency of use and the perceived benefits after 6
months of usage.
Taking into account the bilingual setting of the
study site, all questionnaires as well as the CAPSYS
system itself are available in French and German.
Both at the beginning and at the end of the study,
data are collected through paper questionnaires and
saved in electronic form in a dedicated secure
database.
The CAPSYS study has been approved by the
Luxembourg National Research Ethics Committee
(CNER) (N° 201205/08) and the National
Commission for Data Protection (CNPD)
(T007990).
4 EVALUATION APPROACH
The main objective of the CAPSYS study is the
evaluation of measurable clinical effects of
computer-supported lifestyle coaching in patients
with increased CVD risk factors. Consequently, the
primary endpoint of the study is the change of CVD
risk factors over time in both study arms.
Questionnaire data (q-data) and measurements
(m-data) of physiological parameters (blood
pressure, BMI, HDL, LDL, HbA1c
and glycemia)
are collected at baseline and post-intervention.
Individual risk profiles and patterns of patients will
be generated and analyzed based on official
recommendations by the EACPR (European
Association of Cardiovascular Prevention and
Rehabilitation) (Perk, 2012). Data will be analyzed
using the Student’s t-test approach (Hazewinkel,
2001). Paired t-tests will be applied to find
significant changes in the physiological parameters
between baseline and post-intervention. Unpaired
two-sample t-tests for each parameter can reveal
possible significant differences in increase or
decrease of risk factors between the two groups.
Statistical analyses will be performed using the R
environment, with a significance level of 0.05.
As secondary endpoint, health-related quality of
life (HR-QoL) will be analyzed. The quality of life
data collected through the standardized EQ-5D-5L
questionnaire (health profiles and values of the EQ
visual analogue scale (EQ VAS)) will be
summarized in appropriate charts according to the
EuroQol guidelines.
The usability of the CAPSYS system will be
evaluated based on the results of the SUS form
(standardized numeric evaluation schema) and the
answers to the additional system-specific questions
provided by the IC participants.
5 CONCLUSIONS
The study presented in this article aims at evaluating
the efficacy and usability of the CAPSYS approach
for phone-based lifestyle coaching of CVD patients
concerning risk factor reduction. The results of this
study will be presented in a separate publication
upon study finalization. In case the results provide
proof of clinical impact, the health economic aspects
of the proposed approach will need to be further
investigated. Potential implementation and
maintenance costs concerning the incorporation of
CAPSYS into CVD healthcare will be analyzed and
compared to those of traditional and alternative
CVD prevention approaches. Based on the usability
evaluation results, the CAPSYS system will be
further refined and adapted to the users’ needs.
REFERENCES
WHO, Cardiovascular diseases (CVDs), Fact sheet No.
317, World Health Organization, 2013
Droste, D.W., Keipes, M., 2013. (The reduction of stroke
risk, risk of myocardial infarction and death by healthy
diet and physical activity.) In Bulletin de la Societe des
Sciences Medicales du Grand-Duche de Luxembourg,
2013(2):51-62.
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