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

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ClinicalTrials.gov Identifier: NCT01801631
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : July 28, 2014
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Prof. G.E.H.M. Rutten, UMC Utrecht

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Acute Coronary Event Other: Home visits Other: Consultation by telephone Not Applicable

Detailed Description:
See citation design paper

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
Study Start Date : October 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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.
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.

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.
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.




Primary Outcome Measures :
  1. Change in Diabetes related distress [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in Well-being [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    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

  2. Change in Quality of life [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]

    Euroqol 5 Dimensions (EQ-5D) and the Euroqol Visual Scale (EQ-VAS). The EQ-5D measures general health status on five dimensions:

    1. Mobility
    2. Self-care
    3. Usual activities
    4. Pain/discomfort
    5. Anxiety/depression The EQ-VAS measures the overall health state on a graded, vertical line.

  3. Change in Anxiety and depression [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    Measured with the Hospital Anxiety and Depression Scale (HADS). A questionnaire measuring anxiety (7 items) and depression (7 items).

  4. Change in Physical activity [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    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).

  5. Change in Self care [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    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.

  6. Change in Diabetes coping [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    Measured with the Diabetes Coping Measure (DCM) consisting of four scales measuring diabetes coping: tackling spirit, avoidance, passive resignation and diabetes integration.

  7. Change in Biomedical variables [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    Blood pressure, blood lipids (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) and body mass index


Other Outcome Measures:
  1. Change in Self-efficacy [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    Measured with the Confidence in Diabetes Self-care questionnaire consisting of 20 items measuring diabetes specific self-efficacy.

  2. Change in Illness perceptions [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    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

  3. Change in Spousal support [ Time Frame: At 2 weeks and 5 months after discharge from hospital ]
    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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801631


Locations
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Netherlands
Meander Medical Center
Amersfoort, Netherlands
Gelre Hospitals
Apeldoorn, Netherlands
Lievensberg Hospital
Bergen op Zoom, Netherlands
Amphia Hospital
Breda, Netherlands
Gemini Hospital
Den Helder, Netherlands
Admiraal de Ruyter Hospital
Goes, Netherlands
Beatrix Hospital
Gorinchem, Netherlands
Westfriesgasthuis
Hoorn, Netherlands
Sint Antonius Hospital
Nieuwegein, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Sint Antonius Hospital
Utrecht, Netherlands
University Medical Center
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
Dutch Diabetes Research Foundation
Investigators
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Principal Investigator: Guy E. Rutten, Professor UMC Utrecht

Publications:
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Responsible Party: Prof. G.E.H.M. Rutten, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01801631     History of Changes
Other Study ID Numbers: DF2009-70
Dutch trial registration ( Registry Identifier: NTR3076 )
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014
Keywords provided by Prof. G.E.H.M. Rutten, UMC Utrecht:
Type 2 diabetes
Acute Coronary Event (ACE)
Distress
Self-efficacy
Quality of Life
Depression
Primary care
Illness representations
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases