Diabetes self-management education after pre-selection of patients: design of a randomised controlled trial. Issue 1 (December 2016)

• Record Type: Journal Article
• Authors: Vos, Rimke; Eikelenboom, Nathalie; Klomp, Maarten; Stellato, Rebecca; Rutten, Guy
• Is Part Of: Diabetology & metabolic syndrome. Volume 8:Issue 1(2016)
• Page Start: 1
• Page End: 7
• Publication Date: 2016-12
• Subjects: Type 2 diabetes mellitus -- Self-care -- Psychological adaptation -- Cost-benefit analysis -- Quality of life -- Nurses practice patterns -- Education; Diabetes -- Pathophysiology -- Periodicals; Metabolic syndrome -- Periodicals; 616.462005
• DOI: 10.1186/s13098-016-0199-4
• Languages: English
• ISSNs: 1758-5996

Abstract

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 registration NTR 5330