Kidney Transplantation 360°
| ISRCTN | ISRCTN29416382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29416382 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 03/05/2017
- Registration date
- 05/05/2017
- Last edited
- 27/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. If the kidneys stop working properly, then the body is unable to get rid of the waste products building up in the blood. Eventually, the kidneys are no longer able to support the body’s needs (kidney failure) and so a treatment to replace the work of the failed kidneys is needed. Having a kidney transplant can transform the life of a patient whose kidneys have failed through disease. Follow-up care after kidney transplantation is performed in transplant centers as well as in nephrologist’s (kidney specialist) offices in Germany without organised integrated care of these different sectors of the German health care system. This lack of organization can lead to cardiovascular (heart and blood vessel) complications and patients not properly sticking to follow up care plans. The aim of this study is to find out whether adding case management and a range of mental health and heart and blood vessel (cardiovascular) assessments and treatments can lead to an improvement in quality of life and transplant survival in kidney transplant patients.
Who can participate?
Patients receiving a kidney transplant between 2010 and 2019 in lower Saxoney.
What does the study involve?
In addition to normal care, all participants have a case manager monitor their care for two years. This involves taking part in regular mental health and physical assessments as well as taking part in regular exercise as well as referral to a psychologist to treat them for any mental health issues they may have. They are also regularly contacted by telephone to further monitor their care and have access to their case notes online. The number of appointments participants receive depends on their individual needs. At the start and end of the program, participants complete a range of questionnaires and assessments to determine their physical and mental wellbeing.
What are the possible benefits and risks of participating?
Patients benefit from taking part in the study as it could lead to an improvement in their quality of live, to longer graft survival, less hospitalizations and better exercise capacity. There are no notable risks involved with participating.
Where is the study run from?
1. Hannover Medical School (Germany)
2. Nephrologisches Zentrum Niedersachsen (Germany)
When is the study starting and how long is it expected to run for?
March 2016 to July 2021
Who is funding the study?
Federal Joint Committee of the Federal Republic of Germany (Germany)
Who is the main contact?
Dr Lars Pape
Contact information
Scientific
Hannover Medical School
Carl-Neuberg-Straße 1
Hannover
D-30265
Germany
 ORCID ID |
0000-0002-3635-6418 |
|---|
Study information
| Study design | Multi-centre non-randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.ntx360grad.de |
| Scientific title | The Kidney Transplantation 360° study: A multicenter, multisectoral, multimodal telemedicine-based follow-up care model to improve care and reduce health-care costs after kidney transplantation in children and adults |
| Study acronym | NTX360° |
| Study objectives | After kidney transplantation, case management and psychosomatic/cardoivascular assesments and interventions prolong patient and graft survival, reduce co-morbidities and health care costs and to enhance quality of life. |
| Ethics approval(s) | Ethics board of Hannover Medical School, 10/02/2017, ref: 3464-2017 |
| Health condition(s) or problem(s) studied | Kidney transplantation |
| Intervention | In addition to routine care, the patients receive the following interventions that are not included in routine care: Case management: This takes place over two years and involves continuous organization of KTX related health care by a case manager. Psychosocial assessments: These take place twice yearly over two years and involve assessment of adherence in personal interviews using the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS©). A collaborative rather than confrontational interview style will be used in order to elicit honest replies and to avoid social desirability. We will assess the following potential barriers of adherence using established instruments: cognitive dysfunctions, lack of resources, lack of knowledge regarding IS, experience of adverse events, mental disorders, psychological distress, low quality of life, and low social support. Psychococial intervention: Patients in need of more information about IS will be referred to an educational group offered by the case manager. Patients can also be referred to a psychologist within the psychosocial team who will offer up to eight treatment sessions per year without waiting period. This intervention can be conducted face-to-face or over the internet and will deal with psychosocial correlates of non-adherence (e.g., social or work problems, psychological distress) and offer behavioral interventions. Cardiovascular assessment: This takes place twice yearly over two years and involves a physical examination and an incremental exercise testing on an ergometer including blood lactate measurements for determination of cardiovascular and skeletal muscle function. Furthermore a 30 minute constant load test on a cycle ergometer with ECG, blood pressure, blood lactate and glucose monitoring, a Timed up and go test, a Sit-to-Stand-test and measurement of steps per day will be performed initially and every 6 months for evaluation of second outcome parameters. Training program: This takes place continuously over two years. Exercise training recommendations are derived from exercise intervention studies with heart and renal transplant patients and include moderate endurance training or moderate resistance training every other day: Exercise capacity near to normal (>80% of normal values): Initial duration 15-30min with 35-60% of maximum exercise capacity Exercise capacity reduced (60-80% of normal values): Initial duration 10-20min with 30-50% of maximum exercise capacity Excercise capacity reduced (<60% of normal values): Initial duration 15-20min with 25-40% of maximum exercise capacity Excercise training will be monitored by an exercise physiologist via a wearable system to measure physical activities and the respective heart rates. A regular feed–back, based on continuous training data interpretation, will be given by monthly by video/phone conference in order to motivate the patient and adapt the training prescriptions. In the first year after KTX patients will be seen 4 times face to face (later 2 times a year), and during these occasions patients will be monitored during a 30 minute endurance exercise training. Telemedical visits: Tele-visits will take place in cooperation between the transplant center and the (pediatric) nephrologist in private practice reducing the amount of visits necessary at the transplant center. At the time of the patient’s visit to the nephrologist’s office, an experienced physician from the transplant center will be connected with both via telephone in order to discuss treatment. In case of unexpected medical problems, unscheduled tele-visits are possible. |
| Intervention type | Mixed |
| Primary outcome measure | Health care costs due to hospitalization are measured using health insurance data at end of all interventions (12 or 24 months). |
| Secondary outcome measures | In all patients all endpoints will be evaluated 24 months after study start, taking into account that some patients will only have 12 months of interventions. 1. Adherence for outpatient visits is measured by actual visits/scheduled visits at end of all interventions 2. Adherence to immunosuppressive therapy is measured by BAASIS-Scale at each psychosocial assessment 3. Cardiovascular fitness and stabilization of weight is measured by different parameters at each CV-assessment 4. Quality of life is measured by Peds-QL and/or SF35 at each psychosocial assessment 5. Implementation of an internet-based case file including all sectors of care is assessed using case file at end of all interventions 6. Implementation and acceptance of telemedicine visits are measured using case file at end of all interventions |
| Overall study start date | 01/03/2016 |
| Completion date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 1411 |
| Total final enrolment | 1010 |
| Key inclusion criteria | Patients receiving a kidney transplant between 2010 and 2019 in lower Saxony. |
| Key exclusion criteria | Insurance company does not take part in KTX360° |
| Date of first enrolment | 03/05/2017 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Germany
Study participating centres
Hannover
D-30625
Germany
Hannoversch Münden
D-34346
Germany
Erlangen
D-91054
Germany
Sponsor information
University/education
Carl-Neuberg-Straße 1
Hannover
D-30625
Germany
| Website | www.mh-hannover.de |
|---|---|
"ROR" |
https://ror.org/00f2yqf98 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from ntx360grad@mh-hannover.de |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Results of sub-study on prevalence of mental disorders | 23/02/2022 | 24/02/2022 | Yes | No |
| Other publications | Results of sub-study on cognitive impairment | 31/10/2019 | 27/10/2022 | Yes | No |
| Other publications | Results of sub-study on influence of officially ordered restrictions during the first wave of COVID-19 pandemic on physical activity and quality of life | 07/12/2020 | 27/10/2022 | Yes | No |
| Other publications | Results of sub-study on knowledge about immunosuppressant medication | 25/09/2020 | 27/10/2022 | Yes | No |
| Other publications | Results of sub-study on organ integration | 25/03/2021 | 27/10/2022 | Yes | No |
| Protocol article | 23/08/2017 | 27/10/2022 | Yes | No | |
| Results article | Graft failure | 25/05/2024 | 11/06/2024 | Yes | No |
| Results article | 12/06/2025 | 27/06/2025 | Yes | No |
Editorial Notes
27/06/2025:Publication reference added.
11/06/2024: Publication reference added.
27/10/2022: Publication references added.
22/03/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 02/05/2017 to 03/05/2017.
2. University Hospital of Erlangen was added as a trial participating centre.
3. The intention to publish date was changed from 31/12/2021 to 01/06/2022.
24/02/2022: Publication reference added.
29/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 30/11/2019.
2. The overall trial end date has been changed from 31/07/2021 to 31/01/2021.
3. The total final enrolment number has been added.
