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Eindhoven Long-term Diabetes Education Study


- candidate number23141
- NTR NumberNTR5530
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2015
- Secondary IDs13-521 
- Public TitleEindhoven Long-term Diabetes Education Study
- Scientific TitleEindhoven Long-term Diabetes Education Study
- ACRONYMELDES
- hypothesisThe theory based 12 weeks self-management program ˇ°Beyond Good Intentionsˇ± (BGI) is one of the very few programs that improved cardiovascular risk factors at 9 months follow-up and is cost-effective. Originally it was designed for patients with screen-detected type 2 diabetes, but the program is now implemented on a larger national scale. If long-term effectiveness and a higher cost-effectiveness ratio could be proven, the program will be reimbursed by health insurance companies and implementation across Europe could be encouraged.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaAdults patients (aged
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
1. High self-management capability or low capability on the domains "Anxiety" or "Depression" (of the SeMaS questionnaire)
2. Insufficient cognitive functioning;
3.Insufficient understanding of the Dutch language to follow instructions and to complete questionnaires.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jan-2014
- planned closingdate15-apr-2017
- Target number of participants88
- InterventionsThis study elaborates on the existing self-management course "Beyond Good Intentions". The course lasts 12 weeks and consists of two 30-minutes individual sessions and four 2.5-h group sessions. In addition, one booster-session is given 52 weeks after the second individual session.
- Primary outcomeChange in BMI (difference of 0.77 kg/m2 is considered clinical relevant) between baseline and follow-up (2 years after the start of the course).
Patient randomized to the control group will receive usual care according to the NHG guideline.
- Secondary outcomeChange between baseline and 2 years follow-up of:
1. Clinical measures: systolic blood pressure, HbA1c, lipid profile (total cholesterol, LDL, HDL, triglycerides);
2. Quality of Life;
3. Diabetes self-management behavior (level of physical activity, dietary intake, medication adherence);
4. Proactive coping;
5. Cost-effectiveness of the intervention (total health care resources use during the whole study period)
- TimepointsClinical measures over the complete study period will be extracted from the electronic medical record of the general practitioner. For the primary outcome (BMI) an avarage of 6 measurement over the 2 years study course is expected.
Questionnaires on diabetes self-management, health related quality of life, and proactive coping will be filled in at baseline and 2 years follow-up
- Trial web siteNA
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD Rimke Vos
- CONTACT for SCIENTIFIC QUERIESPhD Rimke Vos
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
European Foundation for the Study of Diabetes
- PublicationsNA
- Brief summary
- Main changes (audit trail)
- RECORD22-okt-2015 - 27-jan-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl