NCT01184937

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

June 25, 2010

Last Update Submit

December 2, 2014

Conditions

Renal Recipients

Outcome Measures

Primary Outcomes (2)

  • Kidney recipients'knowledge level

    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.

    7-8 weeks post kidney transplantation

  • Kidney recipients'knowledge level

    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.

    6 months post kidney transplantation

Secondary Outcomes (4)

  • Kidney recipients' coping

    7-8 weeks post kidney transplantation

  • Kidney recipients' coping

    6 months post kidney transplantation

  • Kidney recipients' quality of life

    7-8 weeks post kidney transplantation

  • Kidney recipients' quality of life

    6 months post kidney transplantation

Study Arms (2)

Patient education program

EXPERIMENTAL
Behavioral: Patient education program

Standard care

NO INTERVENTION

Interventions

Patient education programBEHAVIORAL

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.

Patient education program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18
  • recently had a kidney transplant
  • able to speak, understand and read Norwegian
  • mentally able to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2010

First Posted

August 19, 2010

Study Start

October 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

NO(1)