Diabetes Mellitus
Conditions
Keywords
diabetes, education, randomized, prospective
Brief summary
This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly developed treatment and education module will be tested compared to a waiting-list control group. The module covers the topic diabetes and social issues. Primary outcome variable is diabetes-specific empowerment regarding diabetes and social issues. Secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.
Detailed description
The module consists of one lesson (duration: 90 minutes). The module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by a trained diabetes educator. Patients are randomized either to the immediate participation in the module or to the control group. Control group is a waiting-list control group. Patients in this waiting-list control group get the education after the completion of the 6-month follow-up.
Interventions
BEHAVIORALEducation - Diabetes and Social Issues
Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Social Issues was created. The module covers specific and detailed aspects of the topic social issues such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible.
Sponsors
Forschungsinstitut der Diabetes Akademie Mergentheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Intensive insulin treatment * specific interest in Diabetes and Social Issues * wish to participate in group education * informed consent * fluent in reading and speaking German language
Exclusion criteria
* diabetes duration \< 4 week * severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) * current treatment of a mental disease * cognitive impairment * dementia * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in diabetes-specific empowerment on the adapted Diabetes Empowerment Scale at the 2-week and 6-month follow-up | Baseline, 2-week follow-up , 6-month follow-up | The Diabetes Empowerment Scale was specifically adjusted to cover the topic social issues. Psychometric criteria for these adjusted scale were evaluated in an independent study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in glycemic control (HbA1c) at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | HbA1c will be analyzed in a central laboratory. |
| Change from baseline in health-related quality of life on the EQ-5D at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | — |
| Change from baseline in quality of life on the WHO-5 at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | — |
| Change from baseline in problem-specific distress on the adapted Problem Areas in Diabetes (PAID) Scale at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | The PAID scale was specifically adapted to cover the topic social issues. Psychometric quality was assessed in an independent study |
| Change from baseline in general diabetes-distress at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | — |
| Change from baseline in depressive symptoms on the CES-D at the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | — |
| Change from baseline in self-efficacy on the General Self-Efficacy Scale (GSE) the 2-week and 6-month follow-up | baseline, 2-week follow-up, 6-month follow-up | — |
Countries
Germany
Outcome results
None listed