CoCo: Colour Coded Blood Pressure Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01013467
First received: November 11, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence with home blood pressure measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Zurich

Additional 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
Study First Received: November 11, 2009
Last Updated: December 10, 2013
Health Authority: Switzerland: Swissmedic

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014