Pilot Testing of a Computer-Aided Prevention System (CAPSYS)

Study Protocol of a Randomized Controlled Trial

Lübomira Spassova

, Norbert Rösch

, Debora Vittore

and Dirk W. Droste

Public Research Centre Henri Tudor, SANTEC, 29, avenue John F. Kennedy, 1855, Luxembourg, Luxembourg

University of Applied Sciences Kaiserslautern, Amerikastr. 1, 66482, Zweibrücken, Germany

Centre Hospitalier de Luxembourg, Department of Neurology, 4, rue Ernest Barblé, 1210, Luxembourg, Luxembourg

Keywords: Lifestyle Coaching, CVD Risk Factors, CVD Prevention, Randomized Controlled Trial.

Abstract: The CAPSYS system enables automated lifestyle coaching for CVD patients through a phone-based

interface with the aim of establishing a healthy behavior by reducing specific risk factors. This paper

presents the procedure of a randomized controlled trial currently performed to evaluate the CAPSYS

prevention approach in terms of efficacy and usability.

1 BACKGROUND

Cerebro-cardiovascular diseases (CVDs) – especial-

ly heart disease and stroke – are the leading causes

of mortality worldwide, and it is estimated that the

annual mortality rate for CVDs will even increase in

the coming decades (WHO, 2013). According to the

WHO, unhealty diet, obesity, physical inactivity,

high blood pressure and tobacco use are among the

main risk factors for CVDs. Thus, to prevent heart

disease and stroke, affected persons are advised to

engage in regular physical activity, to avoid tobacco

smoke, to achieve and maintain a normal body

weight, and to stick to a healthy diet rich in fruit and

vegetables, avoiding too much fat and sugar. It could

be shown in several studies and epidemiologial

analyses that the risk of stroke or myocardial

infarction can be reduced through a healthy diet and

regular physical activity (Droste, 2013).

The Computer-aided Prevention System

(CAPSYS) has been developed by health scientists

and IT experts in collaboration with neurologists

with the aim to support patients in the primary and

secondary prevention of CVDs (Spassova, 2013).

This system allows patiens to provide information

on their individual CVD-related risk factors through

a phone-based interface. Based on this data, each

patient receives system-generated customized

feedback on his or her progress and advice on how

to proceed reducing the risk factors that are still in a

critical range. Based on recommendations by the

Luxembourg Medical Scociety, this computerized

processing of patient data allows automated

personalised lifestyle coaching of patients in real

time. The attending physician can monitor the

progress of each patient through a secure web

interface offering a graphical representation of the

development of the corresponding risk factors (see

Figure 1).

The CAPSYS lifestyle coaching approach is

currently evaluated in a randomized controlled trial

(RCT) in terms of efficacy in reducing the

concerned risk factors as well as regarding its

usability and user acceptance.

2 RELATED WORK

In a parallel two-arm RCT with 171 participants

with ischemic heart disease, Maddison et al.

investigated the efficiency of a mobile phone and

internet-based cardiac rehabilitation program, which

was delivered for six months and consisted of

physical exercise prescription and behavioral change

support in form of text messages sent to the

participants of the intervention group (Maddison,

2011). Although no statistical difference could be

observed for the primary outcome, which was peak

oxygen uptake (PVO

), significant differences were

found concerning physical activity, task efficacy and

motivation as well as for the general health domain

of the SF-36 health-related quality of life measure in

favor of the intervention group (Carter, 2013).

Spassova L., Rösch N., Vittore D. and Droste D..

Pilot Testing of a Computer-Aided Prevention System (CAPSYS) - Study Protocol of a Randomized Controlled Trial.

DOI: 10.5220/0005142800500054

In Proceedings of the 2nd International Congress on Cardiovascular Technologies (CARDIOTECHNIX-2014), pages 50-54

ISBN: 978-989-758-055-0

 2014 SCITEPRESS (Science and Technology Publications, Lda.)

Figure 1: Architecture of the CAPSYS system.

In another study, Pfaeffli Dale et al. evaluated the

efficacy of a 4-week healthy eating program in

achieving behavior change among 20 CVD patients

with high blood cholesterol (Pfaeffli Dale, 2014).

The modality of the intervention was very

similar to the one applied in the Maddison study, i.e.

text messages providing support for behavioral

change received through mobile phones or through a

website. However, in this case the aimed

behavioural change consisted in establishing a

healthy diet. The results revealed some post-

intervention increase in perceived self-efficacy

concerning heart-healthy eating.

Walters et al. have developed a mobile phone

and web-based care model for outpatient cardiac

rehabilitation, and they have evaluated this approach

in a 6 week program (Walters, 2010). The system

provides daily motivational messages sent through

SMS and weekly mentoring by human assistants

through video conferencing. These mentoring

sessions involve the setting and assessment of

specific goals concerning exercise and behavior

modification. Some factors, such as movement

activity, are automatically measured through

sensors. Results show significantly higher adherence

rates, larger walking distances, weight reductions

and improved emotional states in the intervention

group as compared to the control group (Walters,

2012).

These empirical results support the assumption

that telephone-based lifestyle coaching can lead to

an improvement in health behavior in the CVD

context. According to the Fogg Behavior Model,

human behavior is based on the presence of three

fundamental factors: motivation, ability and triggers

(Fogg, 2009). In the proposed CAPSYS setting, the

phone-based interventions provide motivational

feedback and at the same time build the triggers for

positive behavior change. The ability of the users to

participate in the coaching intervention is supported

by the simplicity of the phone-based interface

(Rösch, 2013).

3 STUDY DESIGN

The CAPSYS study has been implemented as a

parallel two-arm RCT with the following criteria.

Inclusion criteria:

 Age: from 20 with no upper limit;

 Patients who already suffered a stroke or

Transient Ischemic Attack (TIA);

 Patients with at least two increased risk factors

for stroke:

o High blood pressure

o Overweight

o Low physical activity

o Smoking

o Unhealthy diet

Exclusion criteria:

 Inability to fill out or to understand the informed

consent;

 No signed informed consent;

 Dementia

Participants are contacted and screened for

eligibility by the attending neurologist during

medical consultations. After signing an informed

consent, patients are randomly assigned either to the

standard care group (SC) or to the interventional

care group (IC). A total of 94 patients have been

recruited (SC: 46, IC: 48). At the beginning and at

the end of the 6-month study period, the participants

from both goups are asked to complete a

questionnaire on demographic and medical data,

including:

 Medical history (stroke, TIA, diabetes etc.)

 Current medication

 Risk factors:

o Smoking habits

o Body weight, height ( BMI)

o Blood pressure, heart rate

o Blood test results (HDL, LDL, HbA1c,

glycemia and triglyceride levels)

In addition, three further questionnaires are to be

completed also at the beginning and at the end of the

PilotTestingofaComputer-AidedPreventionSystem(CAPSYS)-StudyProtocolofaRandomizedControlledTrial

study period to collect data about the nutritional

habits, the physical activity and the quality of life of

the participants from both groups.

With the questionnaire on nutritional habits,

participants can self-assess their usual daily or

weekly food consumption at baseline and post-

intervention. The questionnaire encompasses a

number of food groups such as fish, meat, dairy,

fruits, vegetables, sweets, alcohol etc.

The questionnaire on physical activity asks for a

self-assessment of the following types of activity (in

hours and minutes) that the participants usually

perform per week:

 Low intensity: normal breathing, no sweating

 Moderate intensity: slightly accelerated

breathing, potentially some sweating

 High intensity: rapid breathing and sweating

Finally, information about the participants’

quality of life is acquired by means of the

standardized EQ-5D-5L instrument provided by the

EuroQol Group (The EuroQol Group, 1990).

At the beginning of the study, the participants are

assisted by an interviewer (a study nurse, an

assistant doctor or the project staff) in filling in the

questionnaires. The blood pressure and the heart rate

of each participant are measured by the interviewer

at the beginning and at the end of the study period.

Data concerning the participants’ medical history,

current medication and blood test results are taken

from the corresponding medical files. At the end of

the recruitment meeting, patients of both groups are

handed out a leaflet with information on healthy

lifestyle, especially concerning nutrition and

physical activity as guidance for reducing their risk

factors.

Patients in the IC group are assigned a personal

account (patient number and PIN code) for accessing

the CAPSYS system. The interviewer demonstrates

how to use the CAPSYS system and provides a

paper-based user guide with detailed instructions on

the application. The IC participants are advised to

call the CAPSYS system twice a week (preferably

on Mondays and Thursdays).

During the study period, SC participants do not

undergo any special treatment, but they receive the

usual care by their treating physicians. In addition to

the usual medical care, IC participants are provided

the possibility to use the CAPSYS system in order to

provide information about their current lifestyle

concerning certain CVD risk factors and to receive

feedback on the provided values by the system (see

Figure 2). The participants can access the system by

calling a land line number with their stationary or

mobile phones. After they have chosen their

preferred language (French or German) and

authenticated themselves with their patient number

and PIN code, the participants are posed some

automatically generated questions concerning their

current blood pressure and body weight, and about

their physical activity and their consumption of

fruits, vegetables, whole-grain food and sweets on

the previous day. For smokers, cigarette

consumption is also considered.

During the recruitment meeting at the beginning

of the study, participants are instructed on how to

estimate portion sizes for the relevant food groups,

and they are advised to measure their current blood

pressure and body weight, and to write down all

necessary values prior to calling the CAPSYS

system. The system is implemented to run fully

automatically and can be accessed at any time of

day. The questions and feedback generated by

CAPSYS are issued to the users in spoken natural

language by means of text-to-speech software

(TTS). The participants can answer to the questions

by typing in corresponding numerical values using

the phone key pad (e.g. “3” for 3 portions of fruits

Figure 2: Outline of a CAPSYS phone call.

CARDIOTECHNIX2014-InternationalCongressonCardiovascularTechnologies

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.

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