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

Guy EHM Rutten²  Giel Nijpels³  Mieke Rijken¹  Rebecca K Stellato²  Kees J Gorter²  Marise J Kasteleyn² 

[1] NIVEL, Netherlands institute for health services research, Utrecht, The Netherlands;Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, STR 6.131, P.O. box 85500, Utrecht, GA 3508, The Netherlands;EMGO Institute VU University Medical Center, Amsterdam, The Netherlands

关键词: Illness representations;    Primary care;    Depression;    Quality of life;    Self-efficacy;    Self-management;    Distress;    Acute Coronary Event (ACE);    Type 2 diabetes;   

Others  :  812151
DOI  :  10.1186/1758-5996-6-5

 received in 2013-08-26, accepted in 2014-01-05,  发布年份 2014

【 摘 要 】

Background

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.

Methods

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.

Discussion

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

NCT01801631

【 授权许可】

   
2014 Kasteleyn et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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