Kidney TransplantationSMP-NEPNCT02282124
Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation
A study testing Self-management program with monthly sessions in people with Kidney Transplantation and Rental Transplantation, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Rental Transplantation
- What is being tested?
- Self-management program with monthly sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Feb 2018
- 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
- received a kidney or a kidney-pancreas transplant in the University Hospital Zürich
Who cannot join
- unstable psychiatric disorder
- cognitive impairment
- multi-organ transplantation with lung
- liver or heart
- illiteracy
- not able to speak and understand German
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Advanced Practice Nurse-led Self-management Program on Prevention of Weight Gain, Physical Activity and Medication Adherence in Patients in the First Year After Renal Transplantation
The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.
Read the detailed description
Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.
The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.
The specific aims of this study are:
- Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
- Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
- Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.
Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.
Design: Randomised controlled trial, not blinded
Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.
Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.
Intervention
- Conditions
- Kidney Transplantation, Rental Transplantation
- Being tested
- Self-management program with monthly sessions, Usual Care, containing one session
- Keywords
- weight, self-management, exercise
- Medical subject headings
- Body Weight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management program with monthly sessionsBehavioural
Patients participate in 9 sessions during the first 8th month after transplantaiton
Usual Care, containing one sessionBehavioural
Session takes place within the first three months after transplantation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups:
* Group 1: Patients with optimal behaviour in all three behaviours.
* Group 2: Patients with slight deviation (defined) from optimal behaviour in one or more behaviours.
* Group 3: Patients with larger deviation (defined) from optimal behaviour in one or more behaviours.
All patients (group 1-3) will receive an assessment, education and a monthly reassessment.
Patients from group 2 und 3 will receive additionally behavioral education and peer involvement. Patients from group 3 will receive additionally a consilium of specialized healthcare professionals such as a nutritionist, physiotherapist, or psychologist. Receives: Behavioral: Self-management program with monthly sessions |
| Control | Other | Not described Receives: Behavioral: Usual Care, containing one session |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline BMI at 8 months
BMI
Measured: 8th month
Secondary outcomes (7)
difference of activity between control and intervention group at month 8
differences in steps measured with pedometer (Stepwatch)
Measured: month 8
difference of activity between control and intervention group at month 12
differences in steps measured with pedometer (Stepwatch)
Measured: month 12
change from baseline BMI at 12 months
BMI
Measured: 12th month
difference of self-reported adherence between control and intervention group at month 8
Measured: month 8
difference of self-reported adherence between control and intervention group at month 12
Measured: month 12
change from baseline LTM at 8 months
LTM measured with Body Composition Analysis
Measured: 8 months
change from baseline LTM at 12 months
LTM measured with Body Composition Analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startMay 2012
- Primary completionJan 2018
- Study completionFeb 2018
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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Spirig, PHD, RN, Principal investigator, Nursing Director, Head Office of Nursing and Allied Health Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282124
- Sponsor's protocol ID
- KEK-ZK-Nr. 2011-0411
- Acronym
- SMP-NEP
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 2014
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
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 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Advanced Practice Nurse-led Self-management Program on Prevention of Weight Gain, Physical Activity and Medication Adherence in Patients in the First Year After Renal Transplantation
- ClinicalTrials.gov ID
- NCT02282124
- Acronym / sponsor ID
- SMP-NEP / KEK-ZK-Nr. 2011-0411
- Conditions
- Kidney Transplantation, Rental Transplantation
- Keywords
- weight, self-management, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 4 Nov 2014 (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.
The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.
Detailed description
Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.
The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.
The specific aims of this study are:
- Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
- Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
- Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.
Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.
Design: Randomised controlled trial, not blinded
Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.
Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.
Intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Self-management program with monthly sessionsThe intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups: * Group 1: Patients with optimal behaviour in all three behaviours. * Group 2: Patients with slight deviation (defined) from optimal behaviour in one or more behaviours. * Group 3: Patients with larger deviation (defined) from optimal behaviour in one or more behaviours. All patients (group 1-3) will receive an assessment, education and a monthly reassessment. Patients from group 2 und 3 will receive additionally behavioral education and peer involvement. Patients from group 3 will receive additionally a consilium of specialized healthcare professionals such as a nutritionist, physiotherapist, or psychologist. |
| Control | Other | Behavioral: Usual Care, containing one session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- received a kidney or a kidney-pancreas transplant in the University Hospital Zürich
Key exclusion criteria (6 listed)
- unstable psychiatric disorder
- cognitive impairment
- multi-organ transplantation with lung
- liver or heart
- illiteracy
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 |
|---|---|---|
| Self-management program with monthly sessionsPatients participate in 9 sessions during the first 8th month after transplantaiton | Behavioural | Intervention |
| Usual Care, containing one sessionSession takes place within the first three months after transplantation | Behavioural | Control |
Primary outcome
change from baseline BMI at 8 months
Time frame: 8th month
BMI
7 secondary outcomes
difference of activity between control and intervention group at month 8
Time frame: month 8
difference of activity between control and intervention group at month 12
Time frame: month 12
change from baseline BMI at 12 months
Time frame: 12th month
difference of self-reported adherence between control and intervention group at month 8
Time frame: month 8
difference of self-reported adherence between control and intervention group at month 12
Time frame: month 12
change from baseline LTM at 8 months
Time frame: 8 months
change from baseline LTM at 12 months
Time frame: 12 months
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 May 2021.
- 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.
Rebecca Spirig, PHD, RN principal investigator
Nursing Director, Head Office of Nursing and Allied Health Professionals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management program with monthly sessions in people with Kidney Transplantation and Rental Transplantation, run by University of Zurich at 1 site in Switzerland.
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 1 inclusion and 6 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 May 2021. 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 Switzerland. 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?
change from baseline BMI at 8 months (time frame: 8th month). 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 NCT02282124, 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 May 2021.