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Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

NCT ID: NCT00782847

Last Updated: 2008-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-01-31

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.

Conditions

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Diabetic Nephropathy

Keywords

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diabetes mellitus diabetic nephropathy hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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with DiaNe program

study subjects which participated in the DiaNe consultation and support program

Group Type ACTIVE_COMPARATOR

DiaNe consultation and support program

Intervention Type BEHAVIORAL

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

without DiaNe program

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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DiaNe program, DiaNe(R)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma Deutschland GmbH, Grenzach-Wyhlen, Germany

UNKNOWN

Sponsor Role collaborator

Institute for Medical Outcom Research GmbH, Loerrach, Germany

UNKNOWN

Sponsor Role collaborator

DiaNe HCM GmbH

OTHER

Sponsor Role lead

Responsible Party

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Diabetes- und Nierenzentrum Dormagen

Principal Investigators

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Ludwig F Merker, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes- und Nierenzentrum Dormagen

Locations

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Diabetes- und Nierenzentrum Dormagen

Dormagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.

Reference Type DERIVED
PMID: 39171639 (View on PubMed)

Other Identifiers

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DiaNe-Studie

Identifier Type: -

Identifier Source: org_study_id