Cardiovascular Risk Intervention Study to Optimise Treatment in Patients with Hypertension

ISRCTN	ISRCTN44478543
DOI	https://doi.org/10.1186/ISRCTN44478543
Protocol serial number	01GL0501
Sponsor	German Federal Ministry of Education and Research (BMBF) and the Federation of Sickness Fund Boards
Funders	German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]), Federation of Sickness Fund Boards (Spitzenverbände der Gesetzlichen Krankenkassen)

Submission date: 15/02/2006
Registration date: 12/06/2006
Last edited: 08/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Heinz-Harald Abholz
Scientific

Abteilung für Allgemeinmedizin
Universitätsklinik
Moorenstr. 5
Düsseldorf
40225
Germany

Phone	+49 (0)211 8117771
Email	abholz@med.uni-duesseldorf.de

Study information

Primary study design	Interventional
Study design	Cluster-randomised controlled two-arm interventional study
Secondary study design	Cluster randomised trial
Scientific title	Cardiovascular Risk Intervention Study to Optimise Treatment in Patients with Hypertension
Study acronym	CRISTOPH
Study objectives	As of 21/07/2008, the following amendments have been made to this ISRCTN record: 1. The end date of this trial was updated from 31/01/2007 to 31/12/2007. This reflects a delay to this trial due to several factors, mostly related to data collection 2. An amendment has been made to the Primary outcome measures field, as some errors were found in the information provided at time of registration Hypothesis: Absolute cardiovascular risk (CVR), calculated using the SCORE-formula (Conroy et al., European Heart Journal 2003; http://www.ncbi.nlm.nih.gov/pubmed/12788299), can be significantly decreased in patients with high CVR by means of a composed intervention, targeted at general practitioners, of posting specifically adapted guidelines and two educational outreach peer-visits (group A), compared with posting adapted guidelines alone (group B = control). An embedded qualitative study (semi-structured interviews with general practitioners) focuses on the main reasons for physicians' non-compliance with guidelines in the German context.
Ethics approval(s)	Ethics Committee of the Medical Faculty, University of Düsseldorf, 02/12/2005, ref: 2715
Health condition(s) or problem(s) studied	Increased cardiovascular risk
Intervention	This is a cluster-randomised controlled two-arm interventional study with an embedded qualitative study. A cluster is composed of the recruited patients of one GP surgery; in group practices, all GP partners are allocated to the same study arm. Both groups A and B (the control arm) will receive specifically composed information by post, based on current guidelines on cardiovascular disease prevention. In addition, group A will receive two educational outreach peer-visits, directed at a deeper appreciation of the concept of treating patients according to individual absolute cardiovascular risk.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 21/07/2008: Primary endpoint is the mean absolute cardiovascular risk (CVR) of the subset of patients with high CVR (but no manifest cardiovascular disease) in each randomisation group (A versus B). The composite endpoint 'cardiovascular risk' is calculated from several risk factors by using a slightly modified version of the SCORE formula published by Conroy et al. (European Heart Journal 2003). Previous primary outcome measures: Primary endpoint is the mean absolute cardiovascular risk (CVR) of the patients in each group. The composed endpoint cardiovascular risk is calculated from the single given risk factors by using a slightly modified version of the SCORE-formula published by Conroy et al. (European Heart Journal 2003). For the qualitative study: adapting existing guideline tools for physicians' compliance.
Key secondary outcome measure(s)	1. The intervention's effect on blood pressure, cholesterol levels, smoking rates, and physical exercise in patients with: a. A history of manifested CV disease b. High CVR (defined by SCORE >4%) c. Low CVR (SCORE <5%) 2. The intervention's effect on drug treatment, judged by current guidelines, in patients with: a. A history of manifested CV disease b. High CVR c. Low CVR 3. A possible relationship of CVR with: a. Patient gender b. Patients' socioeconomic status c. The quality of the doctor-patient-relationship 4. The intervention's effect on: a. The accuracy with which doctors and patients estimate individual CVR b. The degree to which the patient is being involved in the decision making process
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4212
Key inclusion criteria	102 general practitioners will be recruited to participate in the study, and will be randomised into groups A or B. Each GP recruits a consecutive sample of 40 patients meeting the following criteria: 1. Aged 40-75 years 2. Known diagnosis of hypertension for >6 months 3. Life expectancy not <1 year 4. Fluency in the German language The sample for the qualitative part covers 30 general practitioners not belonging to the quantitative study sample within the same region before the study and 15 general practitioners within the RCT-sample after the quantitative study.
Key exclusion criteria	Exclusion criteria for GPs are: 1. Less than 500 cases per three months (quarter) 2. Atypical patients or practice Exclusion criteria for patients: see inclusion criteria
Date of first enrolment	01/03/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

Germany

Study participating centre

Abteilung für Allgemeinmedizin

Düsseldorf
40225
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/05/2015		Yes	No
Protocol article	protocol	10/06/2008		Yes	No