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Web Based Interactive Treatment and Self-monitoring in Hypertension (WISH)

This study is currently recruiting participants.
Verified January 2012 by VU University Medical Center
Sponsor:
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01504022
First received: October 14, 2011
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of self-measuring of the blood pressure at home and the use of a pro-active web-based feedback system on the blood pressure, number of antihypertensive drugs used, and surrogate cardiovascular markers during a 12 month period will be investigated.


Condition Intervention
Hypertension
 Other: Telecare, selfmonitoring, lifestyl behaviour

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Self Monitoring in Combination With Proactive Web-based Management in the Treatment of Hypertension: a Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Systolic bloodpressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diastolic bloodpressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lifestyle changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    alcohol consumption, smoking,


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group.
Control group.
Experimental: Telecare, self monitoring, lifestyle counseling
Patients in the intervention group will measure their blood pressure with home blood pressure monitor which is linked to a secured website. Patients will measure as recommended in the European guidelines of hypertension. This includes 2 measurements in the morning and two times in the evening on 7 consecutive days every month. The measurements of the first day will be discarded. These measurements will be forwarded to the web-based system, which will be managed by the nurse practitioner and the research doctor. At least every month patients are contacted about the state of their condition. If needed, antihypertensive medication is added of adjusted by the nurse practitioner or research doctor under the supervision of one consultant physician. Tailored lifestyle advices are given every month.
 Other: Telecare, selfmonitoring, lifestyl behaviour
Patients measure their own bloodpressure and the results are shown at a secured website after USB connection of the monitor to the computer. Patients receive medication adjustments and lifestyle advices via this secured website.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years.
  • Use of 3 or more antihypertensive medications.
  • Use of 0,1 or 2 antihypertensive medications and a documented BP equal or greater than 140/90 mmHg (non-diabetic patients)
  • Use of 0,1 or 2 antihypertensive medications and a documented BP equal or greater than 130/80 mmHg (diabetic patients)
  • Patients must be able to measure the BP at home and to communicate with the nurse or physician through the web-based system.

Exclusion Criteria:

  • Younger than 18 years of age, older than 80 years of age.
  • Not fluent in Dutch or English language
  • Pregnancy
  • Life expectancy less than one year
  • No access to a computer or internet
  • Most recent creatinine clearance (24 hour creatinine clearance) < 30 ml/min
  • Class III or IV heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504022

Contacts
Contact: Prabath Nanayakkara, MD, pHD, FRCP +31 020444440596 p.nanayakkara@vumc.nl

Locations
Netherlands
Vu university medical center Recruiting
Amsterdam, Netherlands
Principal Investigator: Irene Vegting, MD            
Sponsors and Collaborators
VU University Medical Center
  More Information

No publications provided

Responsible Party: Prabath W.B. Nanayakkara, MD, PhD, FRCP, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01504022     History of Changes
Other Study ID Numbers: NL37032.029.11
Study First Received: October 14, 2011
Last Updated: January 2, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
Hypertension
self-monitoring
internet
lifestyle modification

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013