NCT01801631

Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

See citation design paper

Conditions

• Type 2 Diabetes
• Acute Coronary Event

Interventions

Type	Name	Description
OTHER	Home visits	In addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit.
OTHER	Consultation by telephone	In addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-03-01
• Last updated: 2014-07-28

Locations

13 sites across 1 country: Netherlands