Clinical trial NCT02444715: Computer-Aided Prevention System
Official title: Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Diseases
Stroke
Cardiovascular Diseases
CVD Risk Factors
Keywords: Lifestyle coaching
Phone-based system
CVD prevention
Patient-centered decision support
Lead sponsor: Luxembourg Institute of Science and Technology
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier du Luxembourg
First posted: 2015-05-14
Enrollment: 94
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: baseline and 6 months
measure: Change in HDL Level
timeFrame: baseline and 6 months
measure: Change in LDL Level
timeFrame: baseline and 6 months
measure: Change in Triglyceride Level
timeFrame: baseline and 6 months
measure: Change in HbA1c Level
timeFrame: baseline and 6 months
measure: Change in Glycaemia Level
timeFrame: baseline and 6 months
measure: Change in BMI Value
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in Fruits and Vegetables Consumption
timeFrame: baseline and 6 months
measure: Change in Whole Grain Food Consumption
timeFrame: baseline and 6 months
measure: Change in Sweets Consumption
timeFrame: baseline and 6 months
measure: Change in Duration of Physical Activity
timeFrame: baseline and 6 months
measure: Change in Quality of Life
timeFrame: baseline and 6 months
Other outcomes:
measure: Usability: SUS Score
timeFrame: 6 months
Locations:
Study officials:
affiliation: Luxembourg Institute of Science and Technology
name: Lübomira Spassova, Dr.-Ing.
role: STUDY_CHAIR
affiliation: Centre Hospitalier de Luxembourg (CHL)
name: Debora Vittore
role: STUDY_CHAIR
affiliation: Centre Hospitalier de Luxembourg (CHL)
name: Dirk W Droste, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Applied Sciences Kaiserslautern
name: Norbert Rösch, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6.
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Spassova L, Vittore D, Droste DW, Rosch N. Randomised controlled trial to evaluate the efficacy and usability of a computerised phone-based lifestyle coaching system for primary and secondary prevention of stroke. BMC Neurol. 2016 Feb 9;16:22. doi: 10.1186/s12883-016-0540-4.