The aim of the DiaDDZOB project is to examine the associations between psychosocial variables (depression, Type D personality), lifestyle factors (self-care behaviors) and diabetes outcomes (e.g. micro- and macrovascular complications of diabetes).…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are depressive symptomatology and Type D personality
(as assessed by means of validated questionnaires). Other study outcomes
include 1) the onset / progression of disease-related outcomes (glycemic
control, micro- and macrovascular complications, insulin initiation,
mortality); 2) quality of life and health status; 3) health care utilisation.
Of further interest is the course of depressive symptoms and the possibly
mediating role of lifestyle-related factors (e.g. physical activity, smoking
behaviour) in the association between depressive symptomatology / Type D
personality and the outcome parameters.
Secondary outcome
Not applicable
Background summary
Type 2 diabetes mellitus is a chronic and disabling metabolic disease,
affecting a growing number of patients worldwide. Treatment can be complex and
burdensome, requiring a substantial degree of self-care responsibility from
patients. Psychosocial factors such as depression and/or Type D personality may
hamper the patients self-care activities, which in turn increase the risk for
the development of diabetes complications. Increasing our understanding of the
role these psychosocial factors play in determining both disease-related
outcomes and utilisation of health care resources can help us to further
improve diabetes care.
Study objective
The aim of the DiaDDZOB project is to examine the associations between
psychosocial variables (depression, Type D personality), lifestyle factors
(self-care behaviors) and diabetes outcomes (e.g. micro- and macrovascular
complications of diabetes). Of further interest is the course of depressive
symptomatology and the association between depression / Type D personality and
quality of life, insulin initiation and health care consumption.
Study design
The current study is an observational cohort study with a prospective
longitudinal design. Assessments will take place on an annual basis, during a
three-year period.
Study burden and risks
The DiaDDZOB project aims to improve diabetes care and management through
increasing our knowledge about the risk factors for poor prognosis, including
the onset / progression of micro- and macrovascular disease. This will be
accomplished by systematic recording and evaluation of disease-related,
psychosocial and lifestyle parameters, in addition to health care utilisation.
Knowledge about psychosocial and lifestyle factors, their interrelationship and
their impact on diabetic outcomes may eventually lead to identifying patients
at risk as well as provide key factors for intervention. All patients will
receive regular diabetes care. The required non-invasive biological
measurements are part of the regular programme. Participants are invited three
times in three consecutive years to complete a questionnaire, that will take
approximately 30 minutes at most. The burden for patients who decide to
participate is thus minimal. Patients will not receive any special incentives,
compensation or treatment for their participation in the study.
Postbus 90153
5000 LE Tilburg
NL
Postbus 90153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
The patient has type 2 diabetes mellitus
The main health care provider at time of entry in the study is the primary care nurse practitioner (PO) / general practitioner
The patient is at least 18 years old
The patient has sufficient mastery of the Dutch language
Exclusion criteria
The patient has a condition that causes hyperglycemia other than type 2 diabetes mellitus
The patient is physically and/or mentally incapable of completing a questionnaire, as judged by the PO (e.g. co-morbid dementia, terminal cancer)
The patient does not consent that the general practitioner is notified of deviant scores on the questionnaire
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27239.015.09 |