To investigate the cost-effectiveness and long-term effects on cardiovascular risk, quality of life and diabetes self-management behavior of the educational program *Beyond Good Intentions* in known type 2 diabetes patients.
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in Body Mass Index (BMI;-1 kg/m2) between baseline and follow-up (2.5
years after the start of the course) between groups.
Secondary outcome
Change in other clinical measures (HbA1c, lipid profile and systolic blood
pressure), quality of life, diabetes self-management behavior (level of
physical activity, dietary intake and medication adherence) and proactive
coping between baseline and follow-up will be determined. Cost-effectiveness
will be based on total health care resources use during the whole study period.
To determine which patient- and disease characteristics are associated with
participation to the BGI course, baseline data of participants will be compared
to those of patients who were approached but declined to participate.
Background summary
The theory based 12 weeks self-management program *Beyond Good
Intentions* (BGI) is one of the very few programs that improved cardiovascular
risk factors at 9 months follow-up and is cost-effective. Originally it was
designed for patients with screen-detected type 2 diabetes, but the program is
now implemented on a larger national scale. If long-term effectiveness and a
higher cost-effectiveness ratio could be proven, the program will be reimbursed
by health insurance companies and implementation across Europe could be
encouraged.
Study objective
To investigate the cost-effectiveness and long-term effects on cardiovascular
risk, quality of life and diabetes self-management behavior of the educational
program *Beyond Good Intentions* in known type 2 diabetes patients.
Study design
A randomized clinical trial with long-term follow-up.
Intervention
Patients in the BGI-group will follow the 12-week course (2 individual
sessions, 4 groupsessions) and a booster session one year thereafter.
Study burden and risks
participants are asked to fill in a questionnaire for pre-selection. Selected
participants are in addition asked to fill in questionnaires on quality of
life, diabetes self-management and proactive coping at baseline and follow-up
(2.5 years after start of the course). Depending on regular clinical controls
(not older than 4 months) an extra blood sample is taken at one or both
measurement occasions. Participants in the BGI-groups receive over a period of
12 weeks two 30-minutes individual sessions and four 2.5-h group sessions. In
addition, one booster-session is given 52 weeks after the second individual
session.
Many diabetes education programs have been developed, but only two European
programs provided long-term results. Until now no European diabetes education
program has proven to be both effective and cost-effective after a period of
more than two years. Our program is very promising in this respect. By
differentiating between patients who will and those who will not benefit from
the course we think we can make this course more effective and cost-effective,
also on the long-run.
Universiteitsweg 100
Utrecht 3584CG
NL
Universiteitsweg 100
Utrecht 3584CG
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with type 2 diabetes mellitus between 3 months * 5 years;
- Adults, aged * 75 years.
Exclusion criteria
- High self-management capability;
- Insufficient cognitive functioning;
- Insufficient understanding of the Dutch language to follow instructions and to complete questionnaires.
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 | NL46285.041.13 |