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

Type 2 Diabetes Clinical Trial

— Diacourse  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801631
• Other study ID #: DF2009-70
• Secondary ID: Dutch trial regi
• Status: Completed
• Phase: N/A
• First received: February 14, 2013
• Last updated: July 25, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

See citation design paper

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Coronary Event
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-efficacy	Measured with the Confidence in Diabetes Self-care questionnaire consisting of 20 items measuring diabetes specific self-efficacy.	At 2 weeks and 5 months after discharge from hospital	No
Other	Change in Illness perceptions	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	At 2 weeks and 5 months after discharge from hospital	No
Other	Change in Spousal support	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	At 2 weeks and 5 months after discharge from hospital	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No