Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy (DiaNe)

October 30, 2008 updated by: DiaNe HCM GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Dormagen, NRW, Germany, D-41539
        • Diabetes- und Nierenzentrum Dormagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: with DiaNe program
study subjects which participated in the DiaNe consultation and support program
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
Other Names:
  • DiaNe program, DiaNe(R)
No Intervention: without DiaNe program
study subjects which received standard care by diabetologist and/or nephrologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
deterioration of kidney function in diabetic nephropathy
Time Frame: 13 months
13 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiaNe HCM GmbH

Collaborators

Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany
Institute for Medical Outcom Research GmbH, Loerrach, Germany

Investigators

  • Principal Investigator: Ludwig F Merker, MD, Diabetes- und Nierenzentrum Dormagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 30, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiaNe-Studie

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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