Development and Effects of a Structural Education Program... | NCT01630824

Studies
Development and Effects of a Structural Education Program in Adult Kidney Transplant Recipients

NCT01630824

Sponsor

University of Jena

Status

Unknown status

Last Update Posted

May 22, 2013Estimated

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Chronic Kidney Disease

Interventions

Structured education program

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Not provided

First Submitted Date

Jun 26, 2012

First Submission Date that Met QC Criteria

Jun 27, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2013

Last Update Posted Date

May 22, 2013Estimated

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Education	Other	Kidney transplant recipients, who undergo the structured education program	Other: Structured education program
Control	No Intervention	Kidney transplant recipients without structured education programm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Structured education program	Other	structured education program after kidney transplantation	Education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
transplant survival		2 years

Secondary Outcomes

Measure	Description	Time Frame
number of rejections		2 years
days at hospital		2 years
blood pressure control

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation

Exclusion Criteria:

severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claudia Schinkoethe	Contact	004936419324623		claudia.schinkoethe@med.uni-jena.de

Overall Officials

Name	Affiliation	Role
Gunter Wolf	University of Jena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nephrology, University of Jena	Recruiting	Jena	Thuringia	07749	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided