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01.12.2014 | Research | Ausgabe 1/2014 Open Access

Diabetology & Metabolic Syndrome 1/2014

Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital – design and development of a randomised controlled trial

Diabetology & Metabolic Syndrome > Ausgabe 1/2014
Marise J Kasteleyn, Kees J Gorter, Rebecca K Stellato, Mieke Rijken, Giel Nijpels, Guy EHM Rutten
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1758-5996-6-5) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they do not have competing interests.

Authors’ contributions

GEHMR is the principle investigator of the trial. The study design and research proposal were worked out by GEHMR, MR, GN and KJG. MJK and KJG are the trial coordinators. MJK drafted the manuscript. RKS was involved in drafting the statistical analysis plan. All authors have corrected draft versions and approved the final manuscript.



Type 2 diabetes mellitus patients with an acute coronary event (ACE) experience decreased quality of life and increased distress. According to the American Diabetes Association, discharge from the hospital is a time of increased distress for all patients. Tailored support specific to diabetes is scarce in that period. We developed an intervention based on Bandura’s Social Cognitive Theory, Leventhal’s Common Sense Model, and results of focus groups. The aim of this study is to evaluate the effectiveness of the intervention to reduce distress in type 2 diabetes patients who experienced a first ACE.


Randomised controlled trial. Two hundred patients are recruited in thirteen hospitals. A diabetes nurse visits the patients in the intervention group (n = 100) at home within three weeks after discharge from hospital, and again after two weeks and two months. The control group (n = 100) receives a consultation by telephone. The primary outcome is diabetes-related distress, measured with the Problem Areas in Diabetes (PAID) questionnaire. Secondary outcomes are well-being, health status, anxiety, depression, HbA1c, blood pressure and lipids. Mediating variables are self-management, self-efficacy and illness representations. Outcomes are measured with questionnaires directly after discharge from hospital and five months later. Biomedical variables are obtained from the records from the primary care physician and the hospital. Differences between groups in change over time are analysed according to the intention-to-treat principle. The Holm-Bonferroni correction is used to adjust for multiplicity.


Type 2 diabetes patients who experience a first ACE need tailored support after discharge from the hospital. This trial will provide evidence on the effectiveness of a supportive intervention in reducing distress in these patients.

Trial registration

Authors’ original file for figure 1
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