Type 2 Diabetes Clinical Trial
Official title:
Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
Background: In type 2 diabetes mellitus patients, an acute coronary event (ACE) may result
in a decreased quality of life and increased distress. According to the American Diabetes
Association, transition from the acute care setting is a high-risk time for all patients,
but tailored support specific to diabetes is scarce in that period. The investigators
developed an intervention by a diabetes nurse to help diabetic patients reduce distress
after their first ACE. The intervention is based on Bandura's Social Cognitive Theory,
Leventhal's Common Sense Model, and on results of focus groups which were conducted to
define the needs and wishes of type 2 diabetes patients and their partners regarding
professional support after an ACE. The aim of this study is to evaluate the effectiveness of
the intervention to reduce distress. The hypothesis is that patients who receive the
intervention will have less diabetes related distress compared to the control group.
Methods/Design: Randomized controlled trial. Patients will be recruited directly after
discharge from hospital. A diabetes nurse will visit the patients in the intervention group
(n = 100) within three weeks after discharge from hospital, two weeks later and two months
later. The control group (n = 100) will receive a telephone consultation. The primary
outcome is diabetes related distress, measured with the Problem Areas in Diabetes
questionnaire (PAID). Secondary outcomes are quality of life, anxiety, depression, HbA1c,
blood pressure and lipids. Mediating variables are self-management, self-efficacy and
illness representations. Variables will be measured with questionnaires directly after
discharge from hospital and five months later. Biomedical variables will be obtained from
the records from the primary care physician and the hospital. Differences between groups in
change over time will be analyzed according to the intention-to-treat principle.
Discussion: Type 2 diabetes patients who experience a first ACE need tailored support after
discharge from the hospital. This trial will provide evidence of the effectiveness of a
supportive intervention to reduce distress in these patients.
See citation design paper ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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