HypertensionCoCoNCT01013467
CoCo: Colour Coded Blood Pressure Control
A study of Hypertension, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Institute of General Practice
Zurich, Canton of Zurich, 8091
About this study
Official title: Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study
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
- Conditions
- Hypertension
- Being tested
- "CoCo" colour coded blood pressure control
- Keywords
- blood pressure, control, adherence, behaviour
- Medical subject headings
- Hypertension, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"CoCo" colour coded blood pressure controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| color coded bloodpressure booklet | Active comparator | Not described Receives: Behavioral: "CoCo" colour coded blood pressure control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.
Measured: 6months
Secondary outcomes (1)
adherence with home blood pressure measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas J. Rosemann, Prof MD, Principal investigator, University Hospital Zurich, Institute of General Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013467
- Sponsor's protocol ID
- 1738
- Acronym
- CoCo
- Status last verified
- Dec 2013
- First submitted
- 11 Nov 2009
- Last updated
- 11 Dec 2013
- Results posted
- No
Publications
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.
PubMed 20398258
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Colour-coded Blood Pressure Diary Improve Blood Pressure Control for Patients in General Practice? A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01013467
- Acronym / sponsor ID
- CoCo / 1738
- Conditions
- Hypertension
- Keywords
- blood pressure, control, adherence, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| color coded bloodpressure booklet | Active comparator | Behavioral: "CoCo" colour coded blood pressure control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "CoCo" colour coded blood pressure controlThe 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. | Behavioural | color coded bloodpressure booklet |
Primary outcome
Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.
Time frame: 6months
1 secondary outcome
adherence with home blood pressure measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Derived from this study: PubMed 20398258Steurer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Rosemann, Prof MD principal investigator
University Hospital Zurich, Institute of General Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypertension, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary. (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.