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
  Purpose

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


Condition Intervention
Renal Recipients
Behavioral: Patient education program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.

Further study details as provided by Oslo University College:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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"


Enrollment: 159
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient education program 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.
No Intervention: Standard care 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • being over 18
  • recently had a kidney transplant
  • able to speak, understand and read Norwegian
  • mentally able to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184937

Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University College
University of Oslo
  More Information

No publications provided

Responsible Party: Professor Astrid Wahl., Department of Nursing and Health Sciences, University of Oslo, Norway
ClinicalTrials.gov Identifier: NCT01184937     History of Changes
Other Study ID Numbers: 182014/V52
Study First Received: June 25, 2010
Last Updated: August 18, 2010
Health Authority: Norway: Norwegian Social Science Data Services

ClinicalTrials.gov processed this record on August 28, 2014