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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Prabath W.B. Nanayakkara, VU University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504022
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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.

Further study details as provided by Prabath W.B. Nanayakkara, VU University Medical Center:

Primary Outcome Measures:
  • Systolic bloodpressure [ Time Frame: 12 months ]
  • Diastolic bloodpressure [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • lifestyle changes [ Time Frame: 12 months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 14, 2011
First Posted: January 4, 2012
Last Update Posted: January 4, 2012
Last Verified: January 2012

Keywords provided by Prabath W.B. Nanayakkara, VU University Medical Center:
Hypertension
self-monitoring
internet
lifestyle modification

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases