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Completed

NCT Number: NCT01013467

CoCo: Colour Coded Blood Pressure Control

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Institute of General Practice

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"CoCo" colour coded blood pressure control

Behavioral

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.

Primary outcomes

  1. 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 outcomes

  1. adherence with home blood pressure measurements

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study

Acronym: CoCo

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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