| - candidate number | 26672 |
| - NTR Number | NTR6840 |
| - ISRCTN | ISRCTN no longer applicable |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 9-feb-2017 |
| - Secondary IDs | 16-4-171 METC |
| - Public Title | Improving treatment adherence in type 2 diabetes patients |
| - Scientific Title | The effectiveness of an online video-tailered eHealth programme, aimed at improving treatment adherence in type 2 diabetes patients |
| - ACRONYM | MDP: My Diabetes Profile |
| - hypothesis | Improving treatment adherence (physical activity levels, unhealthy snacking consumption decrease, adherence to oral and insuline medication) through video-tailored eHealth communication strategies. |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus Type 2 (DM type II), Hyperglycemia, Obesity |
| - Inclusion criteria | - Type 2 Diabetes diagnosis for > 1 year - Using at least 1 glucose lowering medication - Being aged 40-70 years old - Having access to a PC, laptop or tablet - Having no walking disability |
| - Exclusion criteria | - No understanding of the Dutch language - Having no internet access - Using insulin pump therapy only (people using oral antidiabetic medication alongside insulin pump therapy are eligible to participate) |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 7-nov-2017 |
| - planned closingdate | 1-nov-2018 |
| - Target number of participants | 464 |
| - Interventions | My Diabetes Profile eCoach: Tailored Advice on improving physical activity, decreasing unhealthy snacking consumption, improving adherence to oral glucose lowering medication, improving adherence to insulin medication |
| - Primary outcome | Composit lifestyle score which combines improvements in PA, unhealthy snacking, oral antidiabetic medication adherence and insulin therapy adherence, using Z-scores |
| - Secondary outcome | Separate improvements in PA, Unhealthy Snacking, Oral antidiabetic medication adherence and insuline therapy adherence |
| - Timepoints | Baseline assessment and six-months follow-up assessment |
| - Trial web site | http://www.mijndiabetesprofiel.nl/ |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Stan Vluggen |
| - CONTACT for SCIENTIFIC QUERIES | Stan Vluggen |
| - Sponsor/Initiator | Maastricht University, Maastricht University Medical Center (MUMC+), ZIO (Zorg in ontwikkeling) |
| - Funding (Source(s) of Monetary or Material Support) | MUMC+ 2020 |
| - Publications | The effectiveness of a video animated tailored eHealth programme for improving treatment adherence in type 2 diabetes patients. |
| - Brief summary | Treatment adherence in type 2 diabetes patients is suboptimal and could be improved. It is known that tailored eHealth communication strategies can improve treatment adherence, and can make improvements in health behaviours. This is why this study used tailored eHealth communication strategies through video advice, to improve treatment adherence. |
| - Main changes (audit trail) | |
| - RECORD | 9-feb-2017 - 15-dec-2017 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl