No registrations found.
ID
Source
Brief title
Health condition
adults with type 2 diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in BMI (difference of 0.77 kg/m2 is considered clinical relevant) between baseline and follow-up (2 years after the start of the course).
Patient randomized to the control group will receive usual care according to the NHG guideline.
Secondary outcome
Change between baseline and 2 years follow-up of:
1. Clinical measures: systolic blood pressure, HbA1c, lipid profile (total cholesterol, LDL, HDL, triglycerides);
2. Quality of Life;
3. Diabetes self-management behavior (level of physical activity, dietary intake, medication adherence);
4. Proactive coping;
5. Cost-effectiveness of the intervention (total health care resources use during the whole study period)
Study objective
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 design
Clinical measures over the complete study period will be extracted from the electronic medical record of the general practitioner. For the primary outcome (BMI) an avarage of 6 measurement over the 2 years study course is expected.
Questionnaires on diabetes self-management, health related quality of life, and proactive coping will be filled in at baseline and 2 years follow-up
Intervention
This study elaborates on the existing self-management course "Beyond Good Intentions". The course lasts 12
weeks and consists of 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.
Rimke Vos
University Medical Center Utrecht, P.O. Box 85500 (Internal mail no STR 6.313)
Utrecht 3508 GA
The Netherlands
r.c.vos-3@umcutrecht.nl
Rimke Vos
University Medical Center Utrecht, P.O. Box 85500 (Internal mail no STR 6.313)
Utrecht 3508 GA
The Netherlands
r.c.vos-3@umcutrecht.nl
Inclusion criteria
Adults patients (aged
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
1. High self-management capability or low capability on the domains "Anxiety" or "Depression" (of the SeMaS questionnaire)
2. Insufficient cognitive functioning;
3.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 |
|---|---|
| NTR-new | NL5405 |
| NTR-old | NTR5530 |
| Other | : 13-521 |