Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 201
- 试验地点
- 13
- 主要终点
- Change in Diabetes related distress
研究概览
简要总结
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.
详细描述
See citation design paper
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes (>1 year)
- •Discharged from the hospital after a first acute coronary event defined as a Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG) procedure or Percutaneous Transluminal Coronary Angioplasty (PTCA)
- •Sufficient knowledge of the Dutch language
排除标准
- •A serious illness or condition which will prevent full participation
- •Not able to fill in questionnaires
研究组 & 干预措施
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.
干预措施: Home visits (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.
干预措施: Consultation by telephone (Other)
结局指标
主要结局
Change in Diabetes related distress
时间窗: At 2 weeks and 5 months after discharge from hospital
Diabetes related distress measure with the Problem Areas in Diabetes (PAID) questionnaire. The PAID is a Self-reported questionnaire consisting of twenty statements identified as common negative emotions related to living with diabetes. Each item is rated on a 5-point Likert scale, ranging from 0 ("not a problem") to 4 ("a serious problem"). The total score is transformed to a 0-100 scale, with higher score representing higher distress.
次要结局
- Change in Well-being(At 2 weeks and 5 months after discharge from hospital)
- Change in Physical activity(At 2 weeks and 5 months after discharge from hospital)
- Change in Quality of life(At 2 weeks and 5 months after discharge from hospital)
- Change in Anxiety and depression(At 2 weeks and 5 months after discharge from hospital)
- Change in Self care(At 2 weeks and 5 months after discharge from hospital)
- Change in Diabetes coping(At 2 weeks and 5 months after discharge from hospital)
- Change in Biomedical variables(At 2 weeks and 5 months after discharge from hospital)