CoCo: Colour Coded Blood Pressure Control

Study Overview
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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

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: CoCo colour coded blood pressure control


Participation Criteria
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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: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: color coded bloodpressure booklet<br> | Behavioral: CoCo colour coded blood pressure control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary. |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence with home blood pressure measurements |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, control, adherence, behaviour