NCT01013467

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

November 11, 2009

Last Update Submit

December 10, 2013

Conditions

Keywords

blood pressurecontroladherencebehaviour

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 COMPARATOR
Behavioral: "CoCo" colour coded blood pressure control

Interventions

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.

color coded bloodpressure booklet

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

HypertensionBehavior

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas J. Rosemann, Prof MD

    University Hospital Zurich, Institute of General Practice

    PRINCIPAL INVESTIGATOR

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

Locations