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CoCo: Colour Coded Blood Pressure Control

NCT ID: NCT01013467

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension

Keywords

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blood pressure control adherence behaviour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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color coded bloodpressure booklet

Group Type ACTIVE_COMPARATOR

"CoCo" colour coded blood pressure control

Intervention Type 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.

Interventions

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"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas J. Rosemann, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Institute of General Practice

Locations

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University Hospital Zurich, Institute of General Practice

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 20398258 (View on PubMed)

Other Identifiers

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1738

Identifier Type: -

Identifier Source: org_study_id