Training program for relatives of people with diabetes mellitus E10 E11
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Relatives of patients with diagnosed diabetes mellitus type 1 and type 2 with HbA1c values beyond the target range defined by the physician; spouses and other relatives living in the same household like the patient; age over 18 years (both relative and patient).
Exclusion criteria
Exclusion criteria: Demential or serious physical illness which makes regular participation impossible; insufficient knowledge of German; shiftwork; relatives who suffer from diabetes mellitus themselves; relatives with more than one person affected by diabetes in their immediate social environment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is aimed at investigating the difference in diabetes-associated knowledge between relatives who have participated in the training program and those who have not. To this end, participants are asked to complete a questionnaire both before and after the training program and 6 or 12 months after its completion, in which questions of knowledge about the disease diabetes mellitus are integrated. The questionnaire for relatives ( FB A Type 1 & FB A Type 2) is made up of the following standardised and specifically developed measuring instruments: socio-demography - Standard Assessment; quality of Life - SF-12 / short scale L-1; knowledge of diabetes and diabetes-related skills - self-constructed questionnaire; psychic strain - PHQ-9; strain caused by the disease - PAID-5-DFM: Family Members Diabetes Distress; family interaction - DIDP-FM: DAWN Impact of Diabetes Profile - Family Members / DFSS-FM: The DAWN Family Support Scale - Family Members / Diabetes Family Behavior Checklist; evaluation of the program - self-constructed questionnaire. The patient questionnaire (FB B) is made up of the following standardized and specifically developed measuring instruments: socio-demography - Standard Assessment; health condition - CIRS (Cumulative Ilness Rating Scale) / Hba1c value / number of mild and severe hypoglycaemia within the last 12 months; quality of life - SF-12 / short scale L-1; knowledge of diabetes and diabetes-related skills - self constructed questionnaire; psychic strain - PHQ-9; strain caused by the disease - PAID; self management - DSMQ; family interaction - Diabetes Family Behaviour Checklist. Primary endpoint: increased knowledge of diabetes mellitus among relatives 12 months after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is aimed at examining the quality of life, family interaction and the perceived strain on the part of the relatives caused by the family member's diabetes . Secondary endpoints (12M and 6M compared to baseline): quality of life, chronic stress, mood and depressive disorder, self-efficacy, burden of the disease (of the patient), family interaction, knowledge increase on diabetes mellitus 6M after the intervention (questionnaires used as listed in the primary endpoints). | — |
Countries
Germany
Contacts
VDBD e.V.