title: Diabetes self-management education after pre-selection of patients: design of a randomised controlled trial.
abstract: BACKGROUND
  Many self-management programs have been developed so far. Their effectiveness varies. The program 'Beyond Good Intentions' (BGI) is based on proactive coping and has proven to be (cost-) effective in achieving reductions in BMI and blood pressure in screen-detected type 2 diabetes patients up until nine months follow-up. However, its long-term effectiveness in people already known with diabetes is lacking. In addition, its (cost-) effectiveness might increase if people who are likely not to be benefit from the program are excluded in a valid way. Therefore it was aimed to investigate the long-term effects of the educational program BGI on cardiovascular risk, quality of life and diabetes self-management behaviour in a pre-selected group of patients known with type 2 diabetes up to 5 years.
  
  
  METHODS
  Randomised controlled trial with 2.5 year follow-up. Adults (≤75 years) with a type 2 diabetes duration between 3 months and 5 years will be included. With the use of a self-management screening tool (SeMaS) their potential barriers of self-management due to depression and/or anxiety will be determined. Based on the results of the SeMaS selection patients will be randomised (1:1) to the BGI-group (n = 53) or the control-group (n = 53). In addition to receiving usual care, patients in the BGI-group will follow the 12-week theory-based self-management program and a booster session a few months thereafter. The control-group will receive care as usual. The primary outcome is change in Body Mass Index after 2.5 years follow-up. Secondary outcomes are HbA1c, lipid profile and systolic blood pressure, (diabetes) quality of life, level of physical activity, dietary intake and medication adherence and proactive coping. Cost-effectiveness will be based on total use of health care resources during the entire study period. Difference between groups in change over time will be analysed according to intention-to-treat analysis.
  
  
  CONCLUSIONS
  By differentiating between patients who will and those who are likely not to benefit from the educational program, a more (cost-) effective self-management program might be designed, also on the long-run.Trial registrationNTR 5330.
authors.affiliation: Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispostnr. STR.6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: Rimke C
authors.initials: RC
authors.lastname: Vos
authors.affiliation: DOH Care Group, Tilburgseweg-West 100, P.O.Box 7140, 5652 NP Eindhoven, The Netherlands.
authors.forename: Nathalie W D
authors.initials: NW
authors.lastname: Eikelenboom
authors.affiliation: DOH Care Group, Tilburgseweg-West 100, P.O.Box 7140, 5652 NP Eindhoven, The Netherlands.
authors.forename: Maarten
authors.initials: M
authors.lastname: Klomp
authors.affiliation: Department of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispostnr. STR.6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: Rebecca K
authors.initials: RK
authors.lastname: Stellato
authors.affiliation: Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Huispostnr. STR.6.131, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: Guy E H M
authors.initials: GE
authors.lastname: Rutten
keywords: Cost-benefit analysis; Education; Nurses practice patterns; Psychological adaptation; Quality of life; Self-care; Type 2 diabetes mellitus