- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801631
Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital (Diacourse)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amersfoort, Netherlands
- Meander Medical Center
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Apeldoorn, Netherlands
- Gelre Hospitals
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Bergen op Zoom, Netherlands
- Lievensberg Hospital
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Breda, Netherlands
- Amphia Hospital
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Den Helder, Netherlands
- Gemini Hospital
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Goes, Netherlands
- Admiraal de Ruyter Hospital
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Gorinchem, Netherlands
- Beatrix Hospital
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Hoorn, Netherlands
- Westfriesgasthuis
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Nieuwegein, Netherlands
- Sint Antonius Hospital
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Nijmegen, Netherlands
- Canisius Wilhelmina Hospital
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Utrecht, Netherlands
- Diakonessenhuis
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Utrecht, Netherlands
- University Medical Center
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Utrecht, Netherlands
- Sint Antonius Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Diabetes related distress
Time Frame: At 2 weeks and 5 months after discharge from hospital
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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.
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At 2 weeks and 5 months after discharge from hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Well-being
Time Frame: At 2 weeks and 5 months after discharge from hospital
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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
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At 2 weeks and 5 months after discharge from hospital
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Change in Quality of life
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Euroqol 5 Dimensions (EQ-5D) and the Euroqol Visual Scale (EQ-VAS). The EQ-5D measures general health status on five dimensions:
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At 2 weeks and 5 months after discharge from hospital
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Change in Anxiety and depression
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Measured with the Hospital Anxiety and Depression Scale (HADS).
A questionnaire measuring anxiety (7 items) and depression (7 items).
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At 2 weeks and 5 months after discharge from hospital
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Change in Physical activity
Time Frame: At 2 weeks and 5 months after discharge from hospital
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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).
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At 2 weeks and 5 months after discharge from hospital
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Change in Self care
Time Frame: At 2 weeks and 5 months after discharge from hospital
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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.
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At 2 weeks and 5 months after discharge from hospital
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Change in Diabetes coping
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Measured with the Diabetes Coping Measure (DCM) consisting of four scales measuring diabetes coping: tackling spirit, avoidance, passive resignation and diabetes integration.
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At 2 weeks and 5 months after discharge from hospital
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Change in Biomedical variables
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Blood pressure, blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) and body mass index
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At 2 weeks and 5 months after discharge from hospital
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-efficacy
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Measured with the Confidence in Diabetes Self-care questionnaire consisting of 20 items measuring diabetes specific self-efficacy.
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At 2 weeks and 5 months after discharge from hospital
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Change in Illness perceptions
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Measured with the Illness Perception Questionnaire (IPQ) - short version.
Questionnaire assessing the cognitive representation of illness, focuses on seven scales, assessing (1) Timeline acute/chronic and (2) Timeline cyclical (3) Consequences (4) Personal control (5) Treatment control (6) Illness coherence (7) Emotional representation
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At 2 weeks and 5 months after discharge from hospital
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Change in Spousal support
Time Frame: At 2 weeks and 5 months after discharge from hospital
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Measured with the Active Engagement, Protective Buffering and Overprotection (ABO) questionnaire.
Five items measure active engagement, eight items measure protective buffering and six items measure overprotection
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At 2 weeks and 5 months after discharge from hospital
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guy E. Rutten, Professor, UMC Utrecht
Publications and helpful links
General Publications
- Kasteleyn MJ, Gorter KJ, Stellato RK, Rijken M, Nijpels G, Rutten GE. Tailored support for type 2 diabetes patients with an acute coronary event after discharge from hospital - design and development of a randomised controlled trial. Diabetol Metab Syndr. 2014 Jan 18;6(1):5. doi: 10.1186/1758-5996-6-5.
- Kasteleyn MJ, Gorter KJ, van Puffelen AL, Heijmans M, Vos RC, Jansen H, Rutten GE. What follow-up care and self-management support do patients with type 2 diabetes want after their first acute coronary event? A qualitative study. Prim Care Diabetes. 2014 Oct;8(3):195-206. doi: 10.1016/j.pcd.2013.12.001. Epub 2014 Jan 3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF2009-70
- Dutch trial registration (Registry Identifier: NTR3076)
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