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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
ISRCTN29416382 |
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Date of registration:
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05/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Kidney Transplantation 360°
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Scientific title:
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The Kidney Transplantation 360° study: A multicenter, multisectorial, mulitimodal telemedicine based follow-up care model to improve care and reduce health-care costs after kideny transplantation in children and adults |
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Date of first enrolment:
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03/05/2017 |
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Target sample size:
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1411 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN29416382 |
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Study type:
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Interventional |
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Study design:
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Multi-centre non-randomised interventional sudy (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Lars
Pape |
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Address:
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Hannover Medical School
Carl-Neuberg-Straße 1
D-30265
Hannover
Germany |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients receiving a kidney transplant between 2010 and 2019 in lower Saxoney.
Exclusion criteria: Insurance company does not take part in KTX360°
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney transplantation
Surgery
Kidney transplantation
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Intervention(s)
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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
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Primary Outcome(s)
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Health care costs due to hospitalization are measured using health insurance data at end of all interventions (12 or 24 months).
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Federal Joint Committee of the Federal Republic of Germany
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Ethics review
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Status:
Approval date:
Contact:
Ethics board of Hannover Medical School, 10/02/2017, ref: 3464-2017
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/01/2021 |
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URL:
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