Evaluation of an educational program on the prevention of complicated infections in patients with diabetes

ISRCTN	ISRCTN10791836
DOI	https://doi.org/10.1186/ISRCTN10791836
Protocol serial number	U03/175-P230
Sponsor	University Medical Center Utrecht (The Netherlands)
Funders	Public Health Fund (The Netherlands), Diabetes Fund (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Leonie M.A.J. Muller
Scientific

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

Phone	+31 (0)30 2538181
Email	l.m.a.muller@umcutrecht.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DELPHI
Study objectives	A health education program for both patients and general practitioners will change behaviour by 15%.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 doesnt receive any intervention, but is managed according to usual care. The intervention period is five months.
Intervention type	Other
Primary outcome measure(s)	Self-reported behaviour with regard to the uptake of measures relevant to patients and healthcare providers on the basis of the developed educational program.
Key secondary outcome measure(s)	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
Completion date	28/02/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2400
Key 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
Key exclusion criteria	Patients greater than or equal to 85 years.
Date of first enrolment	01/10/2005
Date of final enrolment	28/02/2006

University Medical Center Utrecht (UMCU)

Utrecht
3508 AB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/03/2008		Yes	No