The objectives of the present study are twofold:1 screening patients with diabetes type 2 for psychological risk factors and2 studying the effect of a self-management training on metabolic regulation in patients starting with insuline therapy
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is HbA1c level. Secundaire medical outcome measures are
systolic blood pressure and cholestorol levels.
Secondary outcome
Secondary outcome is the effect of the training on self-efficacy and
self-management behavior. Furthermore, possible ethnic differences in the
effectiveness of the intervention are explored.
Background summary
The prevalence of diabetes type 2 is estimated to be 5,1%, and increasing. Life
style and increasing life expectancy can explain this increase. The risk of a
cardiovasculair indident is about twice to four times higher and 70 to 80% of
the patients die from such an incident. Furthermore, depression is prevalent in
about 10 to 15 % of the patients, together with eating disorders and other
psychological problems. Severe complications occur in diabetic patients, such
as amputations, blindness and renal failure. The incidence of these complations
can be reduced by about 50% when metabolic regulation is good and when
cardiovasculair risk factors are decreased. Succesful treatment of diabetes is
largely dependent on the patient himself. Only 7% of the patients are capable
of adequate self-management and in 25% of the patients metabolic regulation is
inadequate.
Meta-analysis showed that psychological inventions can improve metabolic
regulation and reduce psychological problems. The effect size was large enough
to decrease the risk of microvasculair complications. Few studies have adressed
patients with poor psychological functioning. Furthermore, psychological
problems may form a barriere to succesful treatment of diabetes. Little
research is carried out into the relation of ethnicity and self-management.
Study objective
The objectives of the present study are twofold:
1 screening patients with diabetes type 2 for psychological risk factors and
2 studying the effect of a self-management training on metabolic regulation in
patients starting with insuline therapy
Study design
The study is a randomised controlled study, comparing the effect of the
self-management training to a waitinglist control group receiving standard
medical care.
Intervention
The intervention consists of 10 weekly sessions of 2 hours in groups of 8 to 10
patients. Ingredients of the training are cognitive restructuring and
behavioral techniques. Indivual goals will be formulated for each patient, to
improve self-management of each patient. Attention will be paid to eating and
exercising, controlling glucose levels and self-care.
Study burden and risks
The burden for the participants is the time that the intervention takes.
Whenever psychological stress is too much increased by the intervention,
individual counseling will be provided.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
patients starting with insuline therapy
sufficient understanding of Dutch language
elevated scores on the SCL-90, but below the psychiatric range
Exclusion criteria
diagnosed psychiatric disorders
insufficient understanding of Dutch
no elevated scores on SCL-90
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 | NL14800.078.07 |