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

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. Identifier: NCT01504022
Recruitment Status : Unknown
Verified January 2012 by Prabath W.B. Nanayakkara, VU University Medical Center.
Recruitment status was:  Recruiting
First Posted : January 4, 2012
Last Update Posted : January 4, 2012
Information provided by (Responsible Party):
Prabath W.B. Nanayakkara, VU University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Other: Telecare, selfmonitoring, lifestyl behaviour Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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.
Study Start Date : September 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Systolic bloodpressure [ Time Frame: 12 months ]
  2. Diastolic bloodpressure [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. lifestyle changes [ Time Frame: 12 months ]
    alcohol consumption, smoking,

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01504022

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Contact: Prabath Nanayakkara, MD, pHD, FRCP +31 020444440596

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Vu university medical center Recruiting
Amsterdam, Netherlands
Principal Investigator: Irene Vegting, MD         
Sponsors and Collaborators
VU University Medical Center
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Responsible Party: Prabath W.B. Nanayakkara, MD, PhD, FRCP, VU University Medical Center Identifier: NCT01504022    
Other Study ID Numbers: NL37032.029.11
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: January 2012
Keywords provided by Prabath W.B. Nanayakkara, VU University Medical Center:
lifestyle modification
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases