Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

DiaNe HCM

Status and phase: Completed; Phase 3

Conditions: Diabetic Nephropathy

Treatments: Behavioral: DiaNe consultation and support program

Study type: Interventional

Funder types: Other

Identifiers

NCT00782847

DiaNe-Studie

Details and patient eligibility

About

This study is designated to evaluate the effect of a patients' educational program called DiaNe® for consultation and support people with diabetic kidney disease in an early stage. The aim of the study is to examine if the program is suitable to stop deterioration of kidney function and to maintain or improve glycemic control. The consultation and support program DiaNe® substantially contributes to a better understanding of the affected clients for this complex clinical picture, allows them for specific interventions and creates the rationale for an active therapeutic relationship.

Full description

According to statistics diabetes mellitus is considered to be the leading cause for end stage renal disease in Germany, approximately 35% of the patients starting on dialysis are affected by diabetes-induced nephropathy. This can be seen in countries all over the world. This situation has been known for years. To date, neither structured intervention methods nor educational programs have been designed for and targeting those affected, which would consequently allow for structured, multifactorial intervention at an early stage of diabetic nephropathy. Multifactorial interventions, as published in the Steno-2 trial, appear to be highly effective with regard to long-term complications of diabetes. In order to realize this approach for the affected as well as the medical staff caring for patients with diabetes-induced nephropathy we developed DiaNe®, a consultation and support program, which is designed to give detailed information to the affected in order to induce behavioral changes. We were able to show a clinically significant reduction of microalbuminuria within a first monocenter evaluation trial. We wanted to verify this effect by means of a prospective multicenter randomized cohort trial according to GCP-ICH guidelines.

Enrollment: 125 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetes mellitus
• proven diabetic nephropathy by histological/lab findings and/or discretion of nephrologist
• ability to understand the German language

Exclusion criteria

• end stage renal disease and/or dialysis
• unable or unwilling to follow the protocol
• pregnant women
• discretion of nephrologist

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups

with DiaNe program

Active Comparator group

Description:

study subjects which participated in the DiaNe consultation and support program

Treatment:

Behavioral: DiaNe consultation and support program

without DiaNe program

No Intervention group

Description:

study subjects which received standard care by diabetologist and/or nephrologist