Condition category
Urological and Genital Diseases
Date applied
29/03/2007
Date assigned
30/05/2007
Last edited
23/05/2013
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

Mrs Antje Erler

ORCID ID

Contact details

Institute for General Practice
Johann Wolfgang Goethe University
Theodor-Stern-Kai 7
Frankfurt
D-60590
Germany
erler@allgemeinmedizin.uni-frankfurt.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GK0302

Study information

Scientific title

Acronym

TP 1

Study hypothesis

In comparison with the control group, the intervention will result in a higher proportion of correctly adjusted drugs in patients with chronic renal impairment.

Ethics approval

Approved by Ethics Committee of Johann Wolfgang Goethe University on the 18th September 2006.

Study design

Cluster-randomised controlled trial; we randomised 23 General Practitioner (GP) practices in the intervention and 23 practices in the control group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Chronic renal impairment (grade III or higher)

Intervention

Each participating practice attended one of four consecutive introductory meetings and was randomised to the intervention or control group. The practices are told to recruit ten suitable patients during a period of four weeks after the meeting. The date on which the data sheets for these ten patients arrive at our institute (= T0) will be registered as the start of the six-month follow-up period. Six months later, each practice will be asked to provide data sheets for the same patients (= T1).

Intervention:
Introduction of an electronic support system for dose adjustment of drugs (software DOSING) plus information package about chronic renal impairment for doctors and patients for six months.

Control:
Care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of medications which have not been correctly adjusted to patient's renal function, measured at baseline (T0) and again after six months (T1).

Secondary outcome measures

1. Number of patients in risk group with recently measured creatinine, measured at baseline (T0) and again after six months (T1)
2. Assessment of feasibility and usefulness of the tested electronic support system by participating General Practices (GP's), measured at baseline (T0) and again after six months (T1)

Overall trial start date

21/02/2007

Overall trial end date

13/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patient level:
1. Patients with established chronic renal impaiment grade III or higher (creatinine clearance below 50 ml/min)
2. Patients at risk of developing chronic renal impairment (70 years or older with hypertension = risk group)

Practice level:
1. Use of computer during consultation
2. Use of computer for prescribing medications

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

400 patients

Participant exclusion criteria

Patient level:
1. Terminally ill patients
2. Patients with dialysis treatment

Practice level:
Routine use of an electronic support system for dose adaption in patients with chronic renal impairment.

Recruitment start date

21/02/2007

Recruitment end date

13/02/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Institute for General Practice
Frankfurt
D-60590
Germany

Sponsor information

Organisation

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

Sponsor details

Hannoversche Strasse 28-30
Berlin
10115
Germany

Sponsor type

Government

Website

http://www.bmbf.de/en/index.php

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) (Germany) (ref: 01GK0302) - notification of February 7, 2006

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22953792

Publication citations

  1. Results

    Erler A, Beyer M, Petersen JJ, Saal K, Rath T, Rochon J, Haefeli WE, Gerlach FM, How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial., BMC Fam Pract, 2012, 13, 91, doi: 10.1186/1471-2296-13-91.

Additional files

Editorial Notes