Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
Diacourse
2 other identifiers
interventional
201
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started Oct 2011
Typical duration for not_applicable type-2-diabetes
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 28, 2014
July 1, 2014
2.2 years
February 14, 2013
July 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Change in Well-being
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 Physical activity
At 2 weeks and 5 months after discharge from hospital
Change in Self care
At 2 weeks and 5 months after discharge from hospital
- +2 more secondary outcomes
Other Outcomes (3)
Change in Self-efficacy
At 2 weeks and 5 months after discharge from hospital
Change in Illness perceptions
At 2 weeks and 5 months after discharge from hospital
Change in Spousal support
At 2 weeks and 5 months after discharge from hospital
Study Arms (2)
Home visits
EXPERIMENTALIn 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
OTHERIn 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
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.
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
You may qualify if:
- 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
You may not qualify if:
- A serious illness or condition which will prevent full participation
- Not able to fill in questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- Dutch Diabetes Research Foundationcollaborator
Study Sites (13)
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
Related Publications (2)
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.
PMID: 24438342BACKGROUNDKasteleyn 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.
PMID: 24389352BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy E. Rutten, Professor
UMC Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 14, 2013
First Posted
March 1, 2013
Study Start
October 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 28, 2014
Record last verified: 2014-07