Internet Based Vascular Risk Factor Intervention and Self Management Study

NCT00785031 | Completed

• 2 other identifiers: 80-00702-98-084 ZonMw08-119/O
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases

Keywords

risk management; Self Management; Self-Efficacy; Disease management; nurse practitioner; internet; risk factors; vascular diseases; economic evaluation

Outcome Measures

Primary Outcomes (1)

• Framingham heart risk score

  1 year

Secondary Outcomes (3)

• Percentage of patients achieving treatment goals for each risk factor

  1 year

• Additional costs per additional patient achieving treatment goal

  1 year

• Cost per life year gained, cost per QALY

  1 year

Study Arms (2)

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.

Interventions

internet based vascular risk factor intervention OTHER

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.

Also known as: Disease management, self management, nurse practitioner, internet, risk factors, primary care, vascular diseases

internet based intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in a cardiovascular risk screening program
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead
• Rijnstate Hospital: collaborator

Study Sites (2)

Department of Vascular Medicine UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Rijnstate Hospital

Arnhem, 3508 GA, Netherlands

Location

Related Publications (7)

• 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.

  PMID: 18639410 BACKGROUND

• 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.

  PMID: 17143135 BACKGROUND

• 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.

  PMID: 18242934 BACKGROUND

• 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.

  PMID: 16009526 BACKGROUND

• 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.

  PMID: 15741961 BACKGROUND

• 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.

  PMID: 25995238 DERIVED

• 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.

  PMID: 22692651 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Vascular Diseases

Interventions

Disease Management; Self-Management; Nurse Practitioners; Patient Portals; Risk Factors; Primary Health Care

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Nurses; Health Personnel; Health Records, Personal; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Risk; Probability; Statistics as Topic; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Comprehensive Health Care

Study Officials

• Frank Visseren, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Yolanda van der Graaf, MD PhD

  Julius Center for Health Sciences and Primary Care

  STUDY CHAIR

• Ardine de Wit, MD PhD

  Julius Center for Health Sciences and Primary Care

  STUDY CHAIR

• Karin Kaasjager, MD PhD

  Rijnstate Hospital Arnhem

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

NL (2)