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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18544168
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25947301
Publication citations
-
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.
-
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.