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CoCo: Colour Coded Blood Pressure Control (CoCo)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013467
First Posted: November 13, 2009
Last Update Posted: December 11, 2013
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):
University of Zurich
  Purpose

Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. One of the causes is insufficient self-monitoring and a lack of adherence to therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has positive effects on treatment adherence and is helpful in achieving the target blood pressure.

Only a few studies have investigated whether the adherence for HBPM can be improved through simple measures and better blood pressure monitoring can be achieved.

Objective Improvement of self-monitoring by means of blood pressure self-measurement and improved blood pressure control by using a new colour-coded blood pressure diary


Condition Intervention
Hypertension Behavioral: "CoCo" colour coded blood pressure control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary. [ Time Frame: 6months ]

Secondary Outcome Measures:
  • adherence with home blood pressure measurements [ Time Frame: 6 months ]

Enrollment: 121
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: color coded bloodpressure booklet Behavioral: "CoCo" colour coded blood pressure control
The patients in the intervention group will receive a colour-coded blood pressure record booklet. The corresponding colour coded areas are divided into three areas of green, yellow and red following a traffic light system. The green area covers blood pressure readings up to a maximum of 140/90 mmHg, the yellow area includes systolic readings over 140 to 180 mm Hg and diastolic readings over 90 to 110 mmHg. The red area covers systolic readings over 180 mmHg and diastolic readings over 110 mmHg.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age >18 years
  • BP > 140/90 mmHg Two consecutive measurements carried out in the practice (measured by the general practitioner at the start of the study).
  • Unchanged anti-hypertension treatment for one month before inclusion
  • Patient able to measure blood pressure at home
  • Written informed consent

Exclusion criteria: • Blood pressure reading over 180 mmHg systolic and/or 110 mmHg diastolic.

  • Serious general or psychological illness (malignant tumor, serious depressive episodes or evidence of dementia).
  • Insufficient knowledge of the German language for instruction and blood pressure recording with a booklet.
  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): NCT01013467


Locations
Switzerland
University Hospital Zurich, Institute of General Practice
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Thomas J. Rosemann, Prof MD University Hospital Zurich, Institute of General Practice
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01013467     History of Changes
Other Study ID Numbers: 1738
First Submitted: November 11, 2009
First Posted: November 13, 2009
Last Update Posted: December 11, 2013
Last Verified: December 2013

Keywords provided by University of Zurich:
blood pressure
control
adherence
behaviour