Completed
DiacourseTailored Support for Type 2 Diabetes Patients After Acute Coronary Event Discharge
Study Aim
This study aims to provide tailored supportive care to Type 2 Diabetes patients after they have been discharged following an acute coronary event, with the primary focus on evaluating changes in diabetes-related distress using a self-reported questionnaire.
What is being tested
Home visits
+ Consultation by telephone
Other
Who is being recruted
Behavior+6
+ Behavioral Symptoms
+ Diabetes Mellitus
+5 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: October 2011
Summary
Principal SponsorUMC Utrecht
Last updated: July 28, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2011
Actual date on which the first participant was enrolled.See citation design paper
Principal SponsorUMC Utrecht
Last updated: July 28, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
201 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
BehaviorBehavioral SymptomsDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDepressionDiabetes Mellitus, Type 2
Criteria
3 inclusion criteria required to participate
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)
History of type 2 diabetes ( > 1 year)
Sufficient knowledge of the Dutch language
2 exclusion criteria prevent from participating
A serious illness or condition which will prevent full participation
Not able to fill in questionnaires
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 13 locations
Gelre Hospitals
Apeldoorn, NetherlandsLievensberg Hospital
Bergen op Zoom, NetherlandsAmphia Hospital
Breda, NetherlandsCompleted13 Study Centers