Clinical trial NCT01801631: Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
Official title: Tailored Support for Type 2 Diabetes Patients With an Acute Coronary Event After Discharge From Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Acute Coronary Event
Keywords: Type 2 diabetes
Acute Coronary Event (ACE)
Distress
Self-efficacy
Quality of Life
Depression
Primary care
Illness representations
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2013-03-01
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: See citation design paper

Eligibility 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

Primary outcomes:
measure: Change in Diabetes related distress
timeFrame: At 2 weeks and 5 months after discharge from hospital
Secondary outcomes:
measure: Change in Well-being
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Quality of life
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Anxiety and depression
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Physical activity
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Self care
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Diabetes coping
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Biomedical variables
timeFrame: At 2 weeks and 5 months after discharge from hospital
Other outcomes:
measure: Change in Self-efficacy
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Illness perceptions
timeFrame: At 2 weeks and 5 months after discharge from hospital
measure: Change in Spousal support
timeFrame: At 2 weeks and 5 months after discharge from hospital
Locations:
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
city: Bergen op Zoom
country: Netherlands
facility: Lievensberg Hospital
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Helder
country: Netherlands
facility: Gemini Hospital
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Hospital
city: Gorinchem
country: Netherlands
facility: Beatrix Hospital
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Hospital
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: Sint Antonius Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center
Study officials:
affiliation: UMC Utrecht
name: Guy E. Rutten, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.