NCT01504022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 4, 2012

Status Verified

January 1, 2012

Enrollment Period

1.5 years

First QC Date

October 14, 2011

Last Update Submit

January 2, 2012

Conditions

Hypertension

Keywords

Hypertensionself-monitoringinternetlifestyle modification

Outcome Measures

Primary Outcomes (2)

  • Systolic bloodpressure

    12 months

  • Diastolic bloodpressure

    12 months

Secondary Outcomes (1)

  • lifestyle changes

    12 months

Study Arms (2)

Control group.

NO INTERVENTION

Control group.

Telecare, self monitoring, lifestyle counseling

EXPERIMENTAL

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

Interventions

Telecare, selfmonitoring, lifestyl behaviourOTHER

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.

Telecare, self monitoring, lifestyle counseling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vu university medical center

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Prabath Nanayakkara, MD, pHD, FRCP

CONTACT

+31 020444440596p.nanayakkara@vumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCP

Study Record Dates

First Submitted

October 14, 2011

First Posted

January 4, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 4, 2012

Record last verified: 2012-01

Locations

NL(1)