Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life

This study has been completed.

Sponsor:

Collaborator:

University of Oslo

Information provided by:

Oslo University College

ClinicalTrials.gov Identifier:

NCT01184937

First received: June 25, 2010

Last updated: August 18, 2010

Last verified: May 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	June 25, 2010
Last Updated Date	August 18, 2010
Start Date ^ICMJE	October 2007
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2010)	Kidney recipients`knowledge level [ Time Frame: 7-8 weeks post kidney transplantation ] [ Designated as safety issue: No ] Knowledge level is measured by a self-administrated knowledge questionnaire consisting of 19 items addressing knowledge in relation to three areas: medication, rejection and lifestyle. Each item is rated using a 5 points scale, anchored on the left with the wording "totally disagree"(1), "rather disagree" (2) "either agree or disagree" (3), "quite agree" (4) and to the left with "totally agree"(5). Patients are asked to put a ring around a number to indicate their level of agreement with each item. Kidney recipients`knowledge level [ Time Frame: 6 months post kidney transplantation ] [ Designated as safety issue: No ] Knowledge level is measured by a self-administrated knowledge questionnaire consisting of 19 items addressing knowledge in relation to three areas: medication, rejection and lifestyle. Each item is rated using a 5 points scale, anchored on the left with the wording "totally disagree"(1), "rather disagree" (2) "either agree or disagree" (3), "quite agree" (4) and to the left with "totally agree"(5). Patients are asked to put a ring around a number to indicate their level of agreement with each item.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01184937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 18, 2010)	Kidney recipients` coping [ Time Frame: 7-8 weeks post kidney transplantation ] [ Designated as safety issue: No ] Coping is measured by the following self-administrated questionnaires: "The Generalized Self-efficacy Scale", "The Long-term Medication Behavior Self-efficacy Scale" and "The Moriscy Compliance scale". In addition, the number of missing observations in the patients` "transplant diaries" is counted.(The "transplant diary" contains patients own daily observations of graft function and signs of rejection). Number of missing observations are counted from observation start and during a period of 7-8 weeks. The percent of missed observations of total possible observations are estimated. Kidney recipients` coping [ Time Frame: 6 months post kidney transplantation ] [ Designated as safety issue: No ] Coping is measured by the following self-administrated questionnaires: "The Generalized Self-efficacy Scale", "The Long-term Medication Behavior Self-efficacy Scale" and "The Moriscy Compliance scale". Kidney recipients` quality of life [ Time Frame: 7-8 weeks post kidney transplantation ] [ Designated as safety issue: No ] Quality of life is measured by the following self -adminstred questionnaires: The acute version of the "Short Form Health Survey" (SF-12) and the disease-spesific quality of life questionnaire: "The Kidney Transplant Questionnaire" Kidney recipients` quality of life [ Time Frame: 6 months post kidney transplantation ] [ Designated as safety issue: No ] Quality of life is measured by the following self -adminstred questionnaires: The acute version of the "Short Form Health Survey" (SF-12) and the disease-spesific quality of life questionnaire: "The Kidney Transplant Questionnaire"
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life
Official Title ^ICMJE	Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.
Brief Summary	For patients with end-stage kidney disease, transplantation is the treatment of choice, offering improved quality of life by restored metabolism and freedom from dialysis. However, demands regarding the acquirement of knowledge in life post transplantation are high. In order to reduce rejection episodes, graft loss and the negative consequences of life-long immunosuppressive medication, it is essential for kidney recipients to possess knowledge about important aspects regarding immunosuppressive medication, graft surveillance and the benefit of specific lifestyle behavior. Consequently, patient education is required for this patient group. This randomized controlled trial is investigating the effect of a structured patient education program on kidney recipients' knowledge, coping and quality of life
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Renal Recipients
Intervention ^ICMJE	Behavioral: Patient education program All patients receive standard care. Experimental group receive a structured patient education program based in self-care theory and pedagogical theory, build upon the the principles of the "Pro-Self education program". The intervention program consist of five weekly one-to-one sessions with a transplant nurse, lasting about 40-60 minutes, starting during the first week after discharge and lasting until 7 weeks post transplantation. Education content consists of two levels: general knowledge level and individual knowledge. Each session has a specific program. In addition, academic detailing is used to describe patient's knowledge levels and for tailoring the education to individual needs.
Study Arm (s)	Experimental: Patient education program Intervention: Behavioral: Patient education program No Intervention: Standard care Intervention: Behavioral: Patient education program
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	159
Completion Date	November 2009
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: being over 18 recently had a kidney transplant able to speak, understand and read Norwegian mentally able to participate in the study
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01184937
Other Study ID Numbers ^ICMJE	182014/V52
Has Data Monitoring Committee	Yes
Responsible Party	Professor Astrid Wahl., Department of Nursing and Health Sciences, University of Oslo, Norway
Study Sponsor ^ICMJE	Oslo University College
Collaborators ^ICMJE	University of Oslo
Investigators ^ICMJE	Not Provided
Information Provided By	Oslo University College
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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