CoCo: Colour Coded Blood Pressure Control
CoCo
Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study
1 other identifier
interventional
121
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Oct 2009
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 11, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 11, 2013
December 1, 2013
8 months
November 11, 2009
December 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.
6months
Secondary Outcomes (1)
adherence with home blood pressure measurements
6 months
Study Arms (1)
color coded bloodpressure booklet
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- 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).
- Patient able to measure blood pressure at home
- Written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Institute of General Practice
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
Steurer-Stey C, Zoller M, Chmiel Moshinsky C, Senn O, Rosemann T. Does a colour-coded blood pressure diary improve blood pressure control for patients in general practice: the CoCo trial. Trials. 2010 Apr 14;11:38. doi: 10.1186/1745-6215-11-38.
PMID: 20398258DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas J. Rosemann, Prof MD
University Hospital Zurich, Institute of General Practice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2009
First Posted
November 13, 2009
Study Start
October 1, 2009
Primary Completion
June 1, 2010
Study Completion
October 1, 2010
Last Updated
December 11, 2013
Record last verified: 2013-12