Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Behavioral: DiaNe consultation and support program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with DiaNe program<br>study subjects which participated in the DiaNe consultation and support program | Behavioral: DiaNe consultation and support program<br>* 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<br>* Other names: DiaNe program, DiaNe(R);|
| No Intervention: without DiaNe program<br>study subjects which received standard care by diabetologist and/or nephrologist | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deterioration of kidney function in diabetic nephropathy |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, diabetic nephropathy, hypertension