Cardiovascular Risk Intervention Study to Optimise Treatment in Patients with Hypertension

ISRCTN ISRCTN44478543
DOI https://doi.org/10.1186/ISRCTN44478543
Secondary identifying numbers 01GL0501
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

Study designCluster-randomised controlled two-arm interventional study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleCardiovascular Risk Intervention Study to Optimise Treatment in Patients with Hypertension
Study acronymCRISTOPH
Study objectivesAs 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) studiedIncreased cardiovascular risk
InterventionThis 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 typeOther
Primary outcome measureCurrent 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.
Secondary outcome measures1. 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
Overall study start date01/03/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants102 GPs, 4080 patients; interviews: 30 additional GPs
Key inclusion criteria102 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 criteriaExclusion 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 enrolment01/03/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Abteilung für Allgemeinmedizin
Düsseldorf
40225
Germany

Sponsor information

German Federal Ministry of Education and Research (BMBF) and the Federation of Sickness Fund Boards
Government

c/o Projektträger im DLR
Heinrich-Konen-Str. 1
Bonn
53227
Germany

Phone +49 (0)228 38210
Email claudia.ritter@dlr.de
Website http://www.pt-dlr.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF])

No information available

Federation of Sickness Fund Boards (Spitzenverbände der Gesetzlichen Krankenkassen)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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