- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01013467
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
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
ZH
-
Zurich, ZH, Schweiz, 8091
- University Hospital Zurich, Institute of General Practice
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: color coded bloodpressure booklet
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Primary outcome: change in systolic and/or diastolic blood pressure 6 months after using the new colour-coded blood pressure diary.
Tidsramme: 6months
|
6months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
adherence with home blood pressure measurements
Tidsramme: 6 months
|
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thomas J. Rosemann, Prof MD, University Hospital Zurich, Institute of General Practice
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1738
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