Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

— DiaNe  

Official title:

A Prospective Controlled Randomized Multicenter Trial to Evaluate the Effect of a Structurized Multifactorial Behavior Modifying Consultation and Support Programme DiaNe for People With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782847
• Other study ID #: DiaNe-Studie
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2008
• Last updated: October 30, 2008
• Start date: July 2004
• Est. completion date: January 2007

Study information

• Verified date: October 2008
• Source: DiaNe HCM GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Behavioral:
• DiaNe consultation and support program
the DiaNe consultation and support program for clients with diabetic nephropathy consists of 4 sessions at 90-120 minutes conducted every week in a period of 4 weeks

Locations

Country	Name	City	State
Germany	Diabetes- und Nierenzentrum Dormagen	Dormagen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
DiaNe HCM GmbH	Institute for Medical Outcom Research GmbH, Loerrach, Germany, Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	deterioration of kidney function in diabetic nephropathy		13 months	No
Secondary	HbA1c		13 months	No