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Evaluation study of the training program for relatives of people with diabetes mellitus DiaLife - living together with diabetes

Evaluation study of the training program for relatives of people with diabetes mellitus DiaLife - living together with diabetes - DiaLife

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015157
Enrollment
352
Registered
2018-08-24
Start date
2018-09-20
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Training program for relatives of people with diabetes mellitus E10 E11

Interventions

Group 1: Intervention: Relatives attend all modules of the training program in the respectiveversion, either for relatives of people with type 1 diabetes or type 2 diabetes. Directly before the first

Sponsors

VDBD e.V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactAsja Harder

VDBD e.V.

harder@vdbd.de030/ 847122495

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026