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

Study Overview
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Brief Summary
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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
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See citation design paper

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

Conditions
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Type 2 Diabetes, Acute Coronary Event

Intervention / Treatment
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* Other: Home visits
* Other: Consultation by telephone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: A serious illness or condition which will prevent full participation Not able to fill in questionnaires
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visits<br>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: Home visits<br>* 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.<br>|
| Other: Consultation by telephone<br>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. | Other: Consultation by telephone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diabetes related distress | 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. | At 2 weeks and 5 months after discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Well-being | Measured with the WHO-Five Well-being Index (WHO-5). The five items covering positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things) in the past two weeks | At 2 weeks and 5 months after discharge from hospital | 
| Change in Quality of life | Euroqol 5 Dimensions (EQ-5D) and the Euroqol Visual Scale (EQ-VAS). The EQ-5D measures general health status on five dimensions: Mobility Self-care Usual activities Pain/discomfort Anxiety/depression The EQ-VAS measures the overall health state on a graded, vertical line. | At 2 weeks and 5 months after discharge from hospital | 
| Change in Anxiety and depression | Measured with the Hospital Anxiety and Depression Scale (HADS). A questionnaire measuring anxiety (7 items) and depression (7 items). | At 2 weeks and 5 months after discharge from hospital | 
| Change in Physical activity | Measured with the International Physical Activity Questionnaire (IPAQ). 29 Items measure how many days' physical activities are performed during the past seven days in four domains (work, transportation, housework and leisure-time). | At 2 weeks and 5 months after discharge from hospital | 
| Change in Self care | Measured with the Summary of the Diabetes Self-Care Activities Measure (SDSCA). Eleven items assessing several aspects of the diabetes regimen: general diet, specific diet, exercise, blood glucose testing, foot care, and smoking. Items measure how many days a patient has performed self-care activities in the last seven days. | At 2 weeks and 5 months after discharge from hospital | 
| Change in Diabetes coping | Measured with the Diabetes Coping Measure (DCM) consisting of four scales measuring diabetes coping: tackling spirit, avoidance, passive resignation and diabetes integration. | At 2 weeks and 5 months after discharge from hospital | 
| Change in Biomedical variables | Blood pressure, blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) and body mass index | At 2 weeks and 5 months after discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Acute Coronary Event (ACE), Distress, Self-efficacy, Quality of Life, Depression, Primary care, Illness representations