Computer-Aided Prevention System

Stroke Clinical Trial

— CAPSYS  

Official title:

Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444715
• Other study ID #: CAPSYS-201205/08-1
• Status: Completed
• Phase: N/A
• First received: May 12, 2015
• Last updated: January 20, 2016
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Luxembourg Institute of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Luxembourg: Comité National d'Ethique de Recherche (CNER)
• Study type: Interventional

Clinical Trial Summary

Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke events occur per day in Luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. Thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors.

The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. Based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. Depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal.

The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month randomized controlled study with participants recruited at CHL's neurology department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• At high risk of stroke:

• Already suffered a stroke or Transient Ischemic Attack (TIA) or

• At least two risk factors for stroke:

• High blood pressure

• Overweight

• Low physical activity

• Smoking

• Unhealthy diet

Exclusion Criteria:

• Inability to fill out or to understand the informed consent

• No signed informed consent

• Dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Diseases
• Cerebrovascular Disorders
• CVD Risk Factors
• Stroke

Intervention

Behavioral:
• Standard care
Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
• CAPSYS
In addition to the usual care, patients are asked to call the CAPSYS system twice a week.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lübomira Spassova	Centre Hospitalier du Luxembourg

References & Publications (1)

Spassova L, Vittore D, Droste D, Rösch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usability: SUS Score	The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).; SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.; The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.; The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.	6 months	No
Primary	Change in Systolic Blood Pressure		baseline and 6 months	No
Primary	Change in HDL Level		baseline and 6 months	No
Primary	Change in LDL Level		baseline and 6 months	No
Primary	Change in Triglyceride Level		baseline and 6 months	No
Primary	Change in HbA1c Level		baseline and 6 months	No
Primary	Change in Glycaemia Level		baseline and 6 months	No
Primary	Change in BMI Value		baseline and 6 months	No
Secondary	Change in Fruits and Vegetables Consumption	Self-reported weekly portions of fruits and vegetables consumption; (During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)	baseline and 6 months	No
Secondary	Change in Whole Grain Food Consumption	Self-reported weekly portions of whole grain food consumption; (During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)	baseline and 6 months	No
Secondary	Change in Sweets Consumption	Self-reported weekly portions of sweets consumption; (During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)	baseline and 6 months	No
Secondary	Change in Duration of Physical Activity	Self-reported weekly duration of physical activity of medium or high intensity	baseline and 6 months	No
Secondary	Change in Quality of Life	The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.; In this context, the health value was specified by the participants on a subjective scale ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").	baseline and 6 months	No