Renal RecipientsNCT01184937
Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life
A study testing Patient education program in people with Renal Recipients, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Recipients
- What is being tested?
- Patient education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being over 18
- recently had a kidney transplant
- able to speak, understand and read Norwegian
- mentally able to participate in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.
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
- Conditions
- Renal Recipients
- Being tested
- Patient education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education programBehavioural
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 group | Role | What they receive |
|---|---|---|
| Patient education program | Experimental | Not described Receives: Behavioral: Patient education program |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post kidney transplantation
Secondary outcomes (4)
Kidney recipients' coping
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.
Measured: 7-8 weeks post kidney transplantation
Kidney recipients' coping
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".
Measured: 6 months post kidney transplantation
Kidney recipients' quality of life
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"
Measured: 7-8 weeks post kidney transplantation
Kidney recipients' quality of life
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"
Measured: 6 months post kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal RecipientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184937
- Sponsor's protocol ID
- 182014/V52
- Status last verified
- Dec 2014
- First submitted
- 25 Jun 2010
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Education on Kidney Recipients Knowledge, Coping and Quality of Life. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01184937
- Acronym / sponsor ID
- 182014/V52
- Conditions
- Renal Recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education program | Experimental | Behavioral: Patient education program |
| Standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being over 18
- recently had a kidney transplant
- able to speak, understand and read Norwegian
- mentally able to participate in the study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education programAll 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. | Behavioural | Patient education program |
Primary outcome
Kidney recipients'knowledge level
Time frame: 7-8 weeks post kidney transplantation
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
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.
4 secondary outcomes
Kidney recipients' coping
Time frame: 7-8 weeks post kidney transplantation
Kidney recipients' coping
Time frame: 6 months post kidney transplantation
Kidney recipients' quality of life
Time frame: 7-8 weeks post kidney transplantation
Kidney recipients' quality of life
Time frame: 6 months post kidney transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 36094829Mellon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education program in people with Renal Recipients, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney recipients'knowledge level (time frame: 7-8 weeks post kidney transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.