Computer-Aided Prevention System

NCT02444715 | Completed Results DMC

• 1 other identifier: CAPSYS-201205/08-1
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebrovascular Diseases; Stroke; Cardiovascular Diseases; CVD Risk Factors

Keywords

Lifestyle coaching; Phone-based system; CVD prevention; Patient-centered decision support

Outcome Measures

Primary Outcomes (7)

• Change in Systolic Blood Pressure

  baseline and 6 months

• Change in HDL Level

  baseline and 6 months

• Change in LDL Level

  baseline and 6 months

• Change in Triglyceride Level

  baseline and 6 months

• Change in HbA1c Level

  baseline and 6 months

• Change in Glycaemia Level

  baseline and 6 months

• Change in BMI Value

  baseline and 6 months

Secondary Outcomes (5)

• Change in Fruits and Vegetables Consumption

  baseline and 6 months

• Change in Whole Grain Food Consumption

  baseline and 6 months

• Change in Sweets Consumption

  baseline and 6 months

• Change in Duration of Physical Activity

  baseline and 6 months

• Change in Quality of Life

  baseline and 6 months

Other Outcomes (1)

• Usability: SUS Score

  6 months

Study Arms (2)

Standard care (SC)

ACTIVE COMPARATOR

Behavioral: Standard care

Interventional care (IC)

EXPERIMENTAL

Behavioral: CAPSYS

Interventions

Standard care BEHAVIORAL

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.

Standard care (SC)

CAPSYS BEHAVIORAL

In addition to the usual care, patients are asked to call the CAPSYS system twice a week.

Interventional care (IC)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to fill out or to understand the informed consent
• No signed informed consent
• Dementia

Sponsors & Collaborators

• Lübomira Spassova: lead
• Centre Hospitalier du Luxembourg: collaborator

Related Publications (3)

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

  PMID: 23823433 BACKGROUND

• 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.

  PMID: 34813082 DERIVED

• 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.

  PMID: 26861865 DERIVED

MeSH Terms

Conditions

Cerebrovascular Disorders; Stroke; Cardiovascular Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Lübomira Spassova
• Organization: Luxembourg Institute of Science and Technology

lubomira.spassova@list.lu

+352 275 888 1

Study Officials

• Lübomira Spassova, Dr.-Ing.

  Luxembourg Institute of Science and Technology

  STUDY CHAIR

• Debora Vittore

  Centre Hospitalier de Luxembourg (CHL)

  STUDY CHAIR

• Dirk W Droste, Prof. Dr.

  Centre Hospitalier de Luxembourg (CHL)

  PRINCIPAL INVESTIGATOR

• Norbert Rösch, Prof. Dr.

  University of Applied Sciences Kaiserslautern

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.-Ing.

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: January 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 18, 2016
• Results First Posted: August 24, 2015

Record last verified: 2016-01