Condition category
Circulatory System
Date applied
15/02/2006
Date assigned
12/06/2006
Last edited
08/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heinz-Harald Abholz

ORCID ID

Contact details

Abteilung für Allgemeinmedizin
Universitätsklinik
Moorenstr. 5
Düsseldorf
40225
Germany
+49 (0)211 8117771
abholz@med.uni-duesseldorf.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GL0501

Study information

Scientific title

Cardiovascular Risk Intervention Study to Optimise Treatment in Patients with Hypertension

Acronym

CRISTOPH

Study hypothesis

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

Ethics Committee of the Medical Faculty, University of Düsseldorf, 02/12/2005, ref: 2715

Study design

Cluster-randomised controlled two-arm interventional study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/03/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

102 GPs, 4080 patients; interviews: 30 additional GPs

Participant 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

Recruitment start date

01/03/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Abteilung für Allgemeinmedizin
Düsseldorf
40225
Germany

Sponsor information

Organisation

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

Sponsor details

c/o Projektträger im DLR
Heinrich-Konen-Str. 1
Bonn
53227
Germany
+49 (0)228 38210
claudia.ritter@dlr.de

Sponsor type

Government

Website

http://www.pt-dlr.de

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federation of Sickness Fund Boards (Spitzenverbände der Gesetzlichen Krankenkassen)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18544168
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25947301

Publication citations

  1. Protocol

    Mortsiefer A, Meysen T, Schumacher M, Lintges C, Stamer M, Schmacke N, Wegscheider K, Abholz HH, In der Schmitten J, CRISTOPH - a cluster-randomised intervention study to optimise the treatment of patients with hypertension in General Practice., BMC Fam Pract, 2008, 9, 33, doi: 10.1186/1471-2296-9-33.

  2. Results

    Mortsiefer A, Meysen T, Schumacher M, Abholz HH, Wegscheider K, In der Schmitten J, From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial, BMC Fam Pract, 2015, 16, 1, 56, doi: 10.1186/s12875-015-0274-1.

Additional files

Editorial Notes