Condition category
Infections and Infestations
Date applied
08/03/2006
Date assigned
08/03/2006
Last edited
18/03/2008
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

Ms Leonie M.A.J. Muller

ORCID ID

Contact details

University Medical Center Utrecht (UMCU)
Julius Center for Health Sciences and Primary Care
Str. HP. 6.131
P.O. Box 85060
Utrecht
3508 AB
Netherlands
+31 (0)30 2538181
l.m.a.muller@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U03/175-P230

Study information

Scientific title

Acronym

DELPHI

Study hypothesis

A health education program for both patients and general practitioners will change behaviour by 15%.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Urinary tract infections, lower respiratory tract infections

Intervention

The intervention group of patients and general practitioners participates in an educational program on urinary tract and lower respiratory tract infections. The control group doesn’t receive any intervention, but is managed according to usual care. The intervention period is five months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Self-reported behaviour with regard to the uptake of measures relevant to patients and healthcare providers on the basis of the developed educational program.

Secondary outcome measures

The following outcomes are assessed both in persons with diabetes and in primary health care providers:
1. Awareness of the possibility of an abnormal course and a specific treatment of common infections in persons with diabetes
2. Knowledge about infections and prevention of an abnormal course in persons with diabetes
3. Attitude towards infections in persons with diabetes

Overall trial start date

01/10/2005

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with type 2 diabetes
2. Aged 45 years or older
3. Able to attend a meeting and without a Dutch language barrier

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2400

Participant exclusion criteria

Patients greater than or equal to 85 years.

Recruitment start date

01/10/2005

Recruitment end date

28/02/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Utrecht (UMCU)
Utrecht
3508 AB
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Public Health Fund (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Diabetes Fund (The Netherlands)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18056887

Publication citations

  1. Results

    Venmans LM, Gorter KJ, Hak E, Rutten GE, Short-term effects of an educational program on health-seeking behavior for infections in patients with type 2 diabetes: a randomized controlled intervention trial in primary care., Diabetes Care, 2008, 31, 3, 402-407, doi: 10.2337/dc07-0744.

Additional files

Editorial Notes