Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
21/09/2007
Prospective/Retrospective
Prospectively 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

Dr J.R.J. de Leeuw

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
Department of Nursing Science
P.O. Box 80036
Utrecht
3508 TA
Netherlands
+31 (0)30 2538879
j.r.j.deleeuw@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DIO

Study hypothesis

1. Self-management coaching by an expert patient leads to more control and better quality of life in newly diagnosed patients with diabetes type two
2. Self-management coaching by an expert patient leads to better coping in newly diagnosed patients with diabetes type two
3. Self-management coaching by an expert patient leads to better quality of care in newly diagnosed patients with diabetes type two

Ethics approval

Not provided at time of registration

Study design

Randomised, single blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Diabetes Mellitus type 2

Intervention

Self-management coaching by an expert patient:
Patient-tailored information and counselling about diabetes and its consequences for functioning and lifestyle.

200 patients, included in the study within one year, will be randomised and stratified for sex.
Patients in the experimental group (N = 100) are coached by an expert patient for three months. A self-management program is used with a focus on diet and physical activity. The coaching is given additional to the usual care by the general practitioner, dietician and diabetic nurse.

Before, three and six months after the intervention, all patients complete a questionnaire about quality of life, quality of care, self-efficacy, self-management behaviour and coping.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Self-efficacy.

Secondary outcome measures

1. Quality of life
2. Coping
3. Self-management behaviour
4. Quality of care

Overall trial start date

15/09/2007

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with diabetes type two
2. Good understanding of Dutch language

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. Impaired cognitive function
2. Belonging to minority group for which separate intervention is needed (Turkish, Moroccan, etc.)

Recruitment start date

15/09/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 TA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Julius Centre
Nursing Sciences
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.juliuscentrum.nl/julius/

Funders

Funder type

Research organisation

Funder name

Diabetes Research 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

Publication citations

Additional files

Editorial Notes