Diabetes and Partnership: Evaluation of a Diabetes Education Module
- Conditions
- Diabetes Mellitus
- Interventions
- Behavioral: Education - Diabetes and Partnership
- Registration Number
- NCT02076568
- Lead Sponsor
- Forschungsinstitut der Diabetes Akademie Mergentheim
- 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 partnership". Primary outcome variable is diabetes-specific empowerment regarding diabetes and partnership. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- Intensive insulin treatment
- specific interest in "Diabetes and Partnership"
- wish to participate in group education
- informed consent
- fluent in reading and speaking German language
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Education - Diabetes and Partnership Education - Diabetes and Partnership Patients randomized to this arm, will participate immediately in the education module "Diabetes and Partnership"
- Primary Outcome Measures
Name Time Method 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 "partnership" issues. Psychometric criteria for these adjusted scale were evaluated in an independent study
- Secondary Outcome Measures
Name Time Method 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 "partnership". Psychometric quality was assessed in an independent study
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 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 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
Trial Locations
- Locations (4)
Research Institute of the Diabetes Academy Mergentheim (FIDAM)
🇩🇪Bad Mergentheim, Germany
Zentrum für Diabetologie Bergedorf
🇩🇪Hamburg, Germany
Diabetologische Schwerpunktpraxis Neuss
🇩🇪Neuss, Germany
Diabeteszentrum Ludwigsburg
🇩🇪Ludwigsburg, Germany