The present study examines an extended version of this intervention that aims to address more challenging self-management goals once patients have mastered the skills necessary to achieve relatively small improvements in their self-management. Theā¦
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is self-management behavior (including diet, physical activity,
medication adherence and smoking), corroborated by medical measures (BMI, blood
pressure, Hba1c and lipid profiles).
Secondary outcome
Mediators include self-regulatory competence, self-efficacy, outcome
satisfaction and emotional outcomes. Moderators include sociodemographic
characteristics, self-control, the tendency to be goal oriented and outcome
expectations
Background summary
There is a call for effective interventions which can support patients with
type-2 diabetes in improving their self-management. The present study builds
forth on the success of a previous theory driven intervention proven effective
in helping patients recently diagnosed with type-2 diabetes to achieve and
maintain small changes in self-management behaviors using a proactive 5-step
plan.
Study objective
The present study examines an extended version of this intervention that aims
to address more challenging self-management goals once patients have mastered
the skills necessary to achieve relatively small improvements in their
self-management. The effectiveness of this more challenging goal-setting
strategy will be compared with one that continues to focus on small goals which
are achievable in the short term.
Study design
A prospective randomized controlled design will be employed to compare the
effectiveness of two conditions, (2x150) over 18 months (including 6 month
follow-up). Conditions include the experimental condition (the original course
plus ambitious extension) and a control condition (including the original
course plus extension focusing on small, short-tem goals).
Intervention
All patients will receive the original intervention which uses a 5-step plan,
based on self-regulation theory and proactive coping, to help them translate
their intentions into concrete goals and plans. The original program will be
extended to 12 months and include 4 additional sessions focusing on either
small, realistic goals (control condition) ormore challenging goals geared to
achieving an optimal diabetes management (experimental condition).
Study burden and risks
All patients will receive the original self-management course which has been
proven effective. Patients will fill out 4 questionnaires and about 10ml of
blood will be taken at the beginning and end of the study
Postbus 80140
3508 TC Utrecht
NL
Postbus 80140
3508 TC Utrecht
NL
Listed location countries
Age
Inclusion criteria
certified diagnosis of type-2 diabetes within the last 5 years
sufficient mastery of the dutch language
Exclusion criteria
serious physical and psychiatric comorbidities
insufficient mastery dutch language
simultaneous participation in another self-management education program
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 | NL20285.041.07 |