Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
NCT ID: NCT01801631
Last Updated: 2014-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2011-10-31
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Not able to fill in questionnaires
ALL
No
Sponsors
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Dutch Diabetes Research Foundation
OTHER
UMC Utrecht
OTHER
Responsible Party
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Prof. G.E.H.M. Rutten
Professor
Principal Investigators
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Guy E. Rutten, Professor
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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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
Countries
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References
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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.
Other Identifiers
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Dutch trial registration
Identifier Type: REGISTRY
Identifier Source: secondary_id
DF2009-70
Identifier Type: -
Identifier Source: org_study_id
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