Clinical trial NCT00785031: Internet Based Vascular Risk Factor Intervention and Self Management Study
Official title: Internet-based Vascular Risk Factor Management for Patients With Clinical Manifest Vascular Disease; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: risk management
Self Management
Self-Efficacy
Disease management
nurse practitioner
internet
risk factors
vascular diseases
economic evaluation
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
First posted: 2008-11-05
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Framingham heart risk score
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients achieving treatment goals for each risk factor
timeFrame: 1 year
measure: Additional costs per additional patient achieving treatment goal
timeFrame: 1 year
measure: Cost per life year gained, cost per QALY
timeFrame: 1 year
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Utrecht
country: Netherlands
facility: Department of Vascular Medicine UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Frank Visseren, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Julius Center for Health Sciences and Primary Care
name: Yolanda van der Graaf, MD PhD
role: STUDY_CHAIR
affiliation: Julius Center for Health Sciences and Primary Care
name: Ardine de Wit, MD PhD
role: STUDY_CHAIR
affiliation: Rijnstate Hospital Arnhem
name: Karin Kaasjager, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Goessens 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.
citation: Sol 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.
citation: Sol 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.
citation: Sol 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.
citation: Greving 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.
citation: Vernooij 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.