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N/A N=94 Randomized Prevention

Computer-Aided Prevention System

Cerebrovascular Diseases · Stroke · Cardiovascular Diseases · CVD Risk Factors

Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Change in Systolic Blood Pressure — 0.19; -9 mmHg — p=0.96

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard care (Behavioral); CAPSYS (Behavioral)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Lübomira Spassova
Primary completion
Aug 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Systolic Blood Pressure
0.19; -9 0.96
PRIMARY
Change in HDL Level
1; -2 0.53
PRIMARY
Change in LDL Level
-1; -6 0.76
PRIMARY
Change in Triglyceride Level
-1; -11 0.39
PRIMARY
Change in HbA1c Level
-0.1; -0.1 0.92
PRIMARY
Change in Glycaemia Level
-0.5; -2 0.78
PRIMARY
Change in BMI Value
0.05; -0.26 0.9
SECONDARY
Change in Fruits and Vegetables Consumption
0; 3.5 0.67
SECONDARY
Change in Whole Grain Food Consumption
0; 1 0.26
SECONDARY
Change in Sweets Consumption
0; 0 0.06
SECONDARY
Change in Duration of Physical Activity
0; 0; 0; 0 0.37
SECONDARY
Change in Quality of Life
0; 0 0.64

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02444715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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