Cardiovascular DiseasesIRISNCT00785031
Internet Based Vascular Risk Factor Intervention and Self Management Study
A study testing internet based vascular risk factor intervention in people with Cardiovascular Diseases, run by UMC Utrecht at 2 sites in Netherlands.
Trial summary
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- internet based vascular risk factor intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesNetherlands
- Study dates
- Oct 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in a cardiovascular risk screening program
- 2 or more modifiable risk factors not on target:
- SBP > 140 mmHg
- LDL-c > 2.5 mmol/l
- Triglycerides > 1.7 mmol/l
- BMI > 25 kg/m2
- Diabetes Mellitus or fasting glucose > 6.1 mmol/l
- Smoking
Who cannot join
- No internet access at home
- Unable to read and write Dutch
- Dependent in in daily activities (Ranking score >=3)
- Life expectancy < 2 years or an active malignant disease
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Rijnstate Hospital
Arnhem, 3508 GA
Department of Vascular Medicine UMC Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.
Read the detailed description
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.
Study design: randomized non-blinded trial Study population: patients in the Rijnstate Hospital Arnhem and the UMC Utrecht, The Netherlands with a recent diagnosis of cerebral, cardiac or peripheral artery disease that entered the risk factor screening programs in these hospitals revealing 2 or more treatable risk factors.
Intervention: After the screening program patients will be randomized to usual care alone or to the internet program on top of usual care. Usual care for risk factor management will be delivered by the medical specialist and/or the general practitioner. Patients randomized to the internet based intervention program are first seen by the nurse practitioner on a regular clinic visit. The internet dossier is than created and explained to the patient. Subsequent contacts between nurse practitioner and patient about risk factor management is mainly by the internet. The nurse practitioner works according to the national guidelines for cardiovascular risk management ('CardioVascular Risico Management 2006') and is supervised by an internist. The study period is 1 year. All patients in both groups ware asked to return to the clinic for a follow up measurement of risk factors after 1 year.
Outcome measures: Primary outcome is the difference in Framingham heart risk score between baseline and after 1 year. As secondary outcome the percentage of patients achieving treatment goals for each risk factor and the average change in the absolute value of each risk factors after 1 year will be used.
Sample size calculation/data analysis: 380 patients. Changes in risk factors (absolute change and fraction of patients achieving treatment goal of each risk factor) at the start and after 1 year and between the groups are tested with independent sample t-test and Chi-square test.
Economic evaluation: The balance between costs and effects of the internet based vascular risk factor management program will be compared to usual care. Using a previously developed cardiovascular disease model incremental cost-utility analyses will be conducted with remaining life expectancy as the relevant time horizon.
- Conditions
- Cardiovascular Diseases
- Being tested
- internet based vascular risk factor intervention
- Keywords
- risk management, Self Management, Self-Efficacy, Disease management, nurse practitioner, internet, risk factors, vascular diseases, economic evaluation
- Medical subject headings
- Cardiovascular Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet based vascular risk factor interventionOther
Also called Disease management, self management, nurse practitioner, internet
The patient and a nurse practitioner create an internet dossier and the patient is instructed on how to use the internet dossier. The internet dossier is mainly meant for the patient: to improve knowledge of vascular risk factors, to give an overview of the actual status of the levels of his/her vascular risk factors and to give guidance and personal advice how to treat risk factors with medication and/or lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| internet based intervention | Active comparator | Not described Receives: Other: internet based vascular risk factor intervention |
| usual care | No intervention | Patients receive their usual care from their specialist or general practitioner. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Framingham heart risk score
Measured: 1 year
Secondary outcomes (3)
Percentage of patients achieving treatment goals for each risk factor
Measured: 1 year
Additional costs per additional patient achieving treatment goal
Measured: 1 year
Cost per life year gained, cost per QALY
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital
- Responsible party
- Principal investigator, dr.Frank L.J. Visseren, UMC Utrecht
- Investigators
- Frank Visseren, MD PhD, Principal investigator, UMC UtrechtYolanda van der Graaf, MD PhD, Study chair, Julius Center for Health Sciences and Primary CareArdine de Wit, MD PhD, Study chair, Julius Center for Health Sciences and Primary CareKarin Kaasjager, MD PhD, Study chair, Rijnstate Hospital Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785031
- Sponsor's protocol ID
- 80-00702-98-084 ZonMw
- Other IDs
- 08-119/O
- Acronym
- IRIS
- Status last verified
- Jun 2012
- First submitted
- 4 Nov 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Goessens BM, Visseren FL, de Nooijer J, van den Borne HW, Algra A, Wierdsma J, van der Graaf Y; SMART Study Group. A pilot-study to identify the feasibility of an Internet-based coaching programme for changing the vascular risk profile of high-risk patients. Patient Educ Couns. 2008 Oct;73(1):67-72. doi: 10.1016/j.pec.2008.06.004. Epub 2008 Jul 18.
PubMed 18639410Goessens BM, Visseren FL, Sol BG, de Man-van Ginkel JM, van der Graaf Y; SMART Study Group. A randomized, controlled trial for risk factor reduction in patients with symptomatic vascular disease: the multidisciplinary Vascular Prevention by Nurses Study (VENUS). Eur J Cardiovasc Prev Rehabil. 2006 Dec;13(6):996-1003. doi: 10.1097/01.hjr.0000216549.92184.40.
PubMed 17143135Sol BG, van der Graaf Y, van der Bijl JJ, Goessens BM, Visseren FL. The role of self-efficacy in vascular risk factor management: a randomized controlled trial. Patient Educ Couns. 2008 May;71(2):191-7. doi: 10.1016/j.pec.2007.12.005. Epub 2008 Feb 1.
PubMed 18242934Sol BG, van der Graaf Y, van der Bijl JJ, Goessens NB, Visseren FL. Self-efficacy in patients with clinical manifestations of vascular diseases. Patient Educ Couns. 2006 Jun;61(3):443-8. doi: 10.1016/j.pec.2005.05.011. Epub 2005 Jul 11.
PubMed 16009526Sol BG, van der Bijl JJ, Banga JD, Visseren FL. Vascular risk management through nurse-led self-management programs. J Vasc Nurs. 2005 Mar;23(1):20-4. doi: 10.1016/j.jvn.2004.12.003.
PubMed 15741961Greving JP, Kaasjager HA, Vernooij JW, Hovens MM, Wierdsma J, Grandjean HM, van der Graaf Y, de Wit GA, Visseren FL. Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial. BMJ Open. 2015 May 20;5(5):e007128. doi: 10.1136/bmjopen-2014-007128.
PubMed 25995238Vernooij JW, Kaasjager HA, van der Graaf Y, Wierdsma J, Grandjean HM, Hovens MM, de Wit GA, Visseren FL; SMARTStudy Group. Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial. BMJ. 2012 Jun 12;344:e3750. doi: 10.1136/bmj.e3750.
PubMed 22692651
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00785031
- Acronym / sponsor ID
- IRIS / 80-00702-98-084 ZonMw
- Conditions
- Cardiovascular Diseases
- Keywords
- risk management, Self Management, Self-Efficacy, Disease management, nurse practitioner, internet, risk factors, vascular diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Rijnstate Hospital
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.
Detailed description
The objective of the study is to evaluate the efficacy and cost-effectiveness of an internet based vascular risk factor program on top of usual care compared to usual care alone for treatment of vascular risk factors in patients at high risk for new vascular events.
Study design: randomized non-blinded trial Study population: patients in the Rijnstate Hospital Arnhem and the UMC Utrecht, The Netherlands with a recent diagnosis of cerebral, cardiac or peripheral artery disease that entered the risk factor screening programs in these hospitals revealing 2 or more treatable risk factors.
Intervention: After the screening program patients will be randomized to usual care alone or to the internet program on top of usual care. Usual care for risk factor management will be delivered by the medical specialist and/or the general practitioner. Patients randomized to the internet based intervention program are first seen by the nurse practitioner on a regular clinic visit. The internet dossier is than created and explained to the patient. Subsequent contacts between nurse practitioner and patient about risk factor management is mainly by the internet. The nurse practitioner works according to the national guidelines for cardiovascular risk management ('CardioVascular Risico Management 2006') and is supervised by an internist. The study period is 1 year. All patients in both groups ware asked to return to the clinic for a follow up measurement of risk factors after 1 year.
Outcome measures: Primary outcome is the difference in Framingham heart risk score between baseline and after 1 year. As secondary outcome the percentage of patients achieving treatment goals for each risk factor and the average change in the absolute value of each risk factors after 1 year will be used.
Sample size calculation/data analysis: 380 patients. Changes in risk factors (absolute change and fraction of patients achieving treatment goal of each risk factor) at the start and after 1 year and between the groups are tested with independent sample t-test and Chi-square test.
Economic evaluation: The balance between costs and effects of the internet based vascular risk factor management program will be compared to usual care. Using a previously developed cardiovascular disease model incremental cost-utility analyses will be conducted with remaining life expectancy as the relevant time horizon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internet based intervention | Active comparator | Other: internet based vascular risk factor intervention |
| usual care | No intervention | –Patients receive their usual care from their specialist or general practitioner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participation in a cardiovascular risk screening program
- 2 or more modifiable risk factors not on target:
- SBP > 140 mmHg
- LDL-c > 2.5 mmol/l
- Triglycerides > 1.7 mmol/l
Key exclusion criteria (4 listed)
- No internet access at home
- Unable to read and write Dutch
- Dependent in in daily activities (Ranking score >=3)
- Life expectancy < 2 years or an active malignant disease
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 |
|---|---|---|
| internet based vascular risk factor interventionAlso: Disease management, self management, nurse practitioner, internetThe patient and a nurse practitioner create an internet dossier and the patient is instructed on how to use the internet dossier. The internet dossier is mainly meant for the patient: to improve knowledge of vascular risk factors, to give an overview of the actual status of the levels of his/her vascular risk factors and to give guidance and personal advice how to treat risk factors with medication and/or lifestyle. | Other | internet based intervention |
Primary outcome
Framingham heart risk score
Time frame: 1 year
3 secondary outcomes
Percentage of patients achieving treatment goals for each risk factor
Time frame: 1 year
Additional costs per additional patient achieving treatment goal
Time frame: 1 year
Cost per life year gained, cost per QALY
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Background: PubMed 18639410Goessens BM, Visseren FL, de Nooijer J, van den Borne HW, Algra A, Wierdsma J, van der Graaf Y; SMART Study Group. A pilot-study to identify the feasibility of an Internet-based coaching programme for changing the vascular risk profile of high-risk patients. Patient Educ Couns. 2008 Oct;73(1):67-72. doi: 10.1016/j.pec.2008.06.004. Epub 2008 Jul 18.
- Background: PubMed 17143135Goessens BM, Visseren FL, Sol BG, de Man-van Ginkel JM, van der Graaf Y; SMART Study Group. A randomized, controlled trial for risk factor reduction in patients with symptomatic vascular disease: the multidisciplinary Vascular Prevention by Nurses Study (VENUS). Eur J Cardiovasc Prev Rehabil. 2006 Dec;13(6):996-1003. doi: 10.1097/01.hjr.0000216549.92184.40.
- Background: PubMed 18242934Sol BG, van der Graaf Y, van der Bijl JJ, Goessens BM, Visseren FL. The role of self-efficacy in vascular risk factor management: a randomized controlled trial. Patient Educ Couns. 2008 May;71(2):191-7. doi: 10.1016/j.pec.2007.12.005. Epub 2008 Feb 1.
- Background: PubMed 16009526Sol BG, van der Graaf Y, van der Bijl JJ, Goessens NB, Visseren FL. Self-efficacy in patients with clinical manifestations of vascular diseases. Patient Educ Couns. 2006 Jun;61(3):443-8. doi: 10.1016/j.pec.2005.05.011. Epub 2005 Jul 11.
- Background: PubMed 15741961Sol BG, van der Bijl JJ, Banga JD, Visseren FL. Vascular risk management through nurse-led self-management programs. J Vasc Nurs. 2005 Mar;23(1):20-4. doi: 10.1016/j.jvn.2004.12.003.
- Derived from this study: PubMed 25995238Greving JP, Kaasjager HA, Vernooij JW, Hovens MM, Wierdsma J, Grandjean HM, van der Graaf Y, de Wit GA, Visseren FL. Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial. BMJ Open. 2015 May 20;5(5):e007128. doi: 10.1136/bmjopen-2014-007128.
- Derived from this study: PubMed 22692651Vernooij JW, Kaasjager HA, van der Graaf Y, Wierdsma J, Grandjean HM, Hovens MM, de Wit GA, Visseren FL; SMARTStudy Group. Internet based vascular risk factor management for patients with clinically manifest vascular disease: randomised controlled trial. BMJ. 2012 Jun 12;344:e3750. doi: 10.1136/bmj.e3750.
Related trials for Cardiovascular Diseases
Recruiting
Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease
Moya Moya Disease, Moyamoya Syndrome
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
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.
Frank Visseren, MD PhD principal investigator
UMC Utrecht
Yolanda van der Graaf, MD PhD study chair
Julius Center for Health Sciences and Primary Care
Ardine de Wit, MD PhD study chair
Julius Center for Health Sciences and Primary Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet based vascular risk factor intervention in people with Cardiovascular Diseases, run by UMC Utrecht at 2 sites in Netherlands.
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 4 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Framingham heart risk score (time frame: 1 year). 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 NCT00785031, which also lists 7 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 14 Jun 2012.