Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life
This study has been completed.
Sponsor:
Oslo University College
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 June 13, 2013