Cerebrovascular DiseasesCAPSYSNCT02444715

Computer-Aided Prevention System

A study testing CAPSYS in people with Cerebrovascular Diseases and Stroke, run by Lübomira Spassova.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Cerebrovascular Diseases, Stroke, Cardiovascular Diseases
What is being tested?: CAPSYS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: No sites listed yet
Study dates: Jan 2013to Aug 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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
Being tested: Standard care, CAPSYS
Keywords: Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support
Medical subject headings: Cerebrovascular Disorders, Stroke, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02444715
Study group	Role	What they receive
Standard care (SC)	Active comparator	Not described Receives: Behavioral: Standard care
Interventional care (IC)	Experimental	Not described Receives: Behavioral: CAPSYS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic Blood Pressure
Measured: baseline and 6 months
Change in HDL Level
Measured: baseline and 6 months
Change in LDL Level
Measured: baseline and 6 months
Change in Triglyceride Level
Measured: baseline and 6 months
Change in HbA1c Level
Measured: baseline and 6 months
Change in Glycaemia Level
Measured: baseline and 6 months
Change in BMI Value
Measured: baseline and 6 months

Secondary outcomes (5)

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.)
Measured: baseline and 6 months
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.)
Measured: baseline and 6 months
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.)
Measured: baseline and 6 months
Change in Duration of Physical Activity
Self-reported weekly duration of physical activity of medium or high intensity
Measured: baseline and 6 months
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").
Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Aug 2014

First posted14 May 2015 (estimated)
Study startJan 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cerebrovascular DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02444715
Sponsor's protocol ID: CAPSYS-201205/08-1
Acronym: CAPSYS
Status last verified: Jan 2016
First submitted: 12 May 2015
Last updated: 18 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6.
PubMed 23823433
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.
PubMed 34813082
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.
PubMed 26861865

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruiting
Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients
Fabry Disease
Recruiting
Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
Fallers Aged 60 Years and Older, Biomarkers / Blood
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke

All Cerebrovascular Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Improved Prevention Methods for Cerebro-cardiovascular Diseases Based on a Computer-aided Prevention System
ClinicalTrials.gov ID: NCT02444715
Acronym / sponsor ID: CAPSYS / CAPSYS-201205/08-1
Conditions: Cerebrovascular Diseases, Stroke, Cardiovascular Diseases, CVD Risk Factors
Keywords: Lifestyle coaching, Phone-based system, CVD prevention, Patient-centered decision support
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Lübomira SpassovaUniversity, hospital or other
Collaborators: Centre Hospitalier du Luxembourg
Study start: Jan 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 14 May 2015 (estimated)
Results: Posted 24 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard care (SC)	Active comparator	Behavioral: Standard care
Interventional care (IC)	Experimental	Behavioral: CAPSYS

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

At high risk of stroke:

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard careParticipants 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.	Behavioural	Standard care (SC)
CAPSYSIn addition to the usual care, patients are asked to call the CAPSYS system twice a week.	Behavioural	Interventional care (IC)

Primary outcome

Change in Systolic Blood Pressure
Time frame: baseline and 6 months
Change in HDL Level
Time frame: baseline and 6 months
Change in LDL Level
Time frame: baseline and 6 months
Change in Triglyceride Level
Time frame: baseline and 6 months
Change in HbA1c Level
Time frame: baseline and 6 months
Change in Glycaemia Level
Time frame: baseline and 6 months
Change in BMI Value
Time frame: baseline and 6 months

5 secondary outcomes

Change in Fruits and Vegetables Consumption
Time frame: baseline and 6 months
Change in Whole Grain Food Consumption
Time frame: baseline and 6 months
Change in Sweets Consumption
Time frame: baseline and 6 months
Change in Duration of Physical Activity
Time frame: baseline and 6 months
Change in Quality of Life
Time frame: baseline and 6 months

Results and safety

Results posted to the registry on 24 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Care (SC)	46	36
Interventional Care (IC)	48	32

Primary outcome: Change in Systolic Blood Pressure

Time frame: baseline and 6 months. Mean (Standard Deviation). Unit: mmHg

Measure	Standard Care (SC) n = 32	Interventional Care (IC) n = 28
Value	0.19 (21.34)	-9 (21.37)

Standard Care (SC): p = 0.96, t-test, 2 sided
Interventional Care (IC): p = 0.03, t-test, 2 sided

Population analysed: Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.

Primary outcome: Change in HDL Level

Time frame: baseline and 6 months. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Standard Care (SC) n = 41	Interventional Care (IC) n = 37
Value	1 (-5 to 7)	-2 (-7 to 4)

Standard Care (SC): p = 0.53, Wilcoxon (Mann-Whitney)
Interventional Care (IC): p = 0.44, Wilcoxon (Mann-Whitney)

Population analysed: For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.

Primary outcome: Change in LDL Level

Time frame: baseline and 6 months. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Standard Care (SC) n = 41	Interventional Care (IC) n = 37
Value	-1 (-17 to 10)	-6 (-16 to 3)

Standard Care (SC): p = 0.76, Wilcoxon (Mann-Whitney)
Interventional Care (IC): p = 0.04, Wilcoxon (Mann-Whitney)

Population analysed: For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.

Primary outcome: Change in Triglyceride Level

Time frame: baseline and 6 months. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Standard Care (SC) n = 30	Interventional Care (IC) n = 32
Value	-1 (-33.25 to 18)	-11 (-37.5 to 10.25)

Standard Care (SC): p = 0.39, Wilcoxon (Mann-Whitney)
Interventional Care (IC): p = 0.04, Wilcoxon (Mann-Whitney)

Population analysed: For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care (SC)	0 of 46 (0%)	0 of 46 (0%)	Not reported
Interventional Care (IC)	0 of 48 (0%)	0 of 48 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23823433Spassova L, Vittore D, Droste D, Rosch N. Automated lifestyle coaching for cerebro-cardiovascular disease prevention. Stud Health Technol Inform. 2013;190:234-6.
Derived from this study: PubMed 34813082Crocker 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.
Derived from this study: PubMed 26861865Spassova 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.

Related trials for Cerebrovascular Diseases

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Active, not recruiting
Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients
Fabry Disease
Recruiting
Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for "Repeated Fallers" Hospitalized in Geriatric Wards
Fallers Aged 60 Years and Older, Biomarkers / Blood
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lübomira Spassova, Dr.-Ing. study chair

Luxembourg Institute of Science and Technology

Debora Vittore study chair

Centre Hospitalier de Luxembourg (CHL)

Dirk W Droste, Prof. Dr. principal investigator

Centre Hospitalier de Luxembourg (CHL)

Questions about this trial

What is this clinical trial studying?

A study testing CAPSYS in people with Cerebrovascular Diseases and Stroke, run by Lübomira Spassova.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure (time frame: baseline and 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02444715, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.