PMID- 30290275 OWN - NLM STAT- MEDLINE DCOM- 20191125 LR - 20240320 IS - 1559-2030 (Electronic) IS - 1551-7144 (Linking) VI - 74 DP - 2018 Nov TI - A web-based program to improve treatment adherence in patients with type 2 diabetes: Development and study protocol. PG - 38-45 LID - S1551-7144(18)30333-1 [pii] LID - 10.1016/j.cct.2018.10.002 [doi] AB - BACKGROUND: Many patients with type 2 diabetes mellitus (T2DM) sub-optimally adhere to core treatment recommendations, such as healthy diets, sufficient physical activity and pharmacological support. This paper describes the development of the web-based computer-tailored program My Diabetes Profile (MDP), incorporating identified success factors of web-based interventions, and the protocol for testing the effectiveness of this program in a randomized multicentre trial. METHODS: Formative research - including the input of a program committee, qualitative and quantitative studies with patients and health professionals and a literature search - yielded input for the development of the MDP program. MDP provides video and text tailored advice, based on determinants and salient beliefs derived from the I-Change Model, on decreasing unhealthy snack intake, increasing physical activity, and improving adherence to both oral blood glucose lowering drugs and self-administered insulin therapy. Patients with T2DM recruited by practice nurses and diabetes nurses across the Netherlands fill in online questionnaires at baseline and six-months follow-up. Participants are randomized on patient level to the intervention group (access to the MDP program) or control group (receiving care as usual). DISCUSSION: The formative research using co-creation principles proved essential in the development of the MDP program and involved various disciplines in T2DM management including target group representatives. Co-creation revealed clearly that patients needed short and attractive messages. Consequently, a mix of video and short text messages were chosen for the ultimate program format. Pilot testing was useful to further shape the program to needs of patients and professionals. TRIAL REGISTRATION: Dutch Trial Register NTR6840; Archived program website: http://www.webcitation.org/6xXz01S7X. CI - Copyright (c) 2018 Elsevier Inc. All rights reserved. FAU - Vluggen, S AU - Vluggen S AD - Department of Health Promotion, School CAPHRI, Maastricht University, Maastricht, the Netherlands. Electronic address: stan.vluggen@maastrichtuniversity.nl. FAU - Hoving, C AU - Hoving C AD - Department of Health Promotion, School CAPHRI, Maastricht University, Maastricht, the Netherlands. Electronic address: c.hoving@maastrichtuniversity.nl. FAU - Schaper, N C AU - Schaper NC AD - Department of Endocrinology and Internal Medicine, School CAPHRI, Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands. Electronic address: n.schaper@mumc.nl. FAU - de Vries, H AU - de Vries H AD - Department of Health Promotion, School CAPHRI, Maastricht University, Maastricht, the Netherlands. Electronic address: hein.devries@maastrichtuniversity.nl. LA - eng SI - NTR/NTR6840 PT - Clinical Trial Protocol PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20181002 PL - United States TA - Contemp Clin Trials JT - Contemporary clinical trials JID - 101242342 RN - 0 (Hypoglycemic Agents) SB - IM MH - Adult MH - Aged MH - Diabetes Mellitus, Type 2/*therapy MH - *Diet, Healthy MH - *Exercise MH - Humans MH - Hypoglycemic Agents/*therapeutic use MH - *Internet MH - *Medication Adherence MH - Middle Aged MH - Netherlands MH - Program Development MH - Treatment Adherence and Compliance MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - Computer-tailoring OT - Effect evaluation OT - Randomized controlled trial OT - Study protocol OT - Treatment adherence OT - Type 2 diabetes EDAT- 2018/10/06 06:00 MHDA- 2019/11/26 06:00 CRDT- 2018/10/06 06:00 PHST- 2018/05/31 00:00 [received] PHST- 2018/09/28 00:00 [revised] PHST- 2018/10/01 00:00 [accepted] PHST- 2018/10/06 06:00 [pubmed] PHST- 2019/11/26 06:00 [medline] PHST- 2018/10/06 06:00 [entrez] AID - S1551-7144(18)30333-1 [pii] AID - 10.1016/j.cct.2018.10.002 [doi] PST - ppublish SO - Contemp Clin Trials. 2018 Nov;74:38-45. doi: 10.1016/j.cct.2018.10.002. Epub 2018 Oct 2.