CoCo: Colour Coded Blood Pressure Control

Hypertension Clinical Trial

— CoCo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013467
• Other study ID #: 1738
• Status: Completed
• Phase: N/A
• First received: November 11, 2009
• Last updated: December 10, 2013
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Institute of General Practice	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.		6months	No
Secondary	adherence with home blood pressure measurements		6 months	No