Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy
DiaNe
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
1 other identifier
interventional
125
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedOctober 31, 2008
October 1, 2008
2.5 years
October 30, 2008
October 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
deterioration of kidney function in diabetic nephropathy
13 months
Secondary Outcomes (1)
HbA1c
13 months
Study Arms (2)
with DiaNe program
ACTIVE COMPARATORstudy subjects which participated in the DiaNe consultation and support program
without DiaNe program
NO INTERVENTIONstudy subjects which received standard care by diabetologist and/or nephrologist
Interventions
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
Eligibility Criteria
You may qualify if:
- diabetes mellitus
- proven diabetic nephropathy by histological/lab findings and/or discretion of nephrologist
- ability to understand the German language
You may not qualify if:
- end stage renal disease and/or dialysis
- unable or unwilling to follow the protocol
- pregnant women
- discretion of nephrologist
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes- und Nierenzentrum Dormagen
Dormagen, North Rhine-Westphalia, D-41539, Germany
Related Publications (1)
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.
PMID: 39171639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ludwig F Merker, MD
Diabetes- und Nierenzentrum Dormagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
July 1, 2004
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
October 31, 2008
Record last verified: 2008-10