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van CCT (UK)

van CCT (UK)

Assessment of a disease management system with medical devices in renal disease.

- candidate number13181
- NTR NumberNTR3548
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2012
- Secondary IDsP11.188 / NL33387.058.11; METC LUMC / CCMO
- Public TitleAssessment of a disease management system with medical devices in renal disease.
- Scientific TitleAssessment of a Disease Management system with medical devices In REnal disease.
- hypothesisReduction of policlinic visits in posttransplantational care without loss of quality by transferring part of care to the homesetting.
- Healt Condition(s) or Problem(s) studiedKidney, Renal transplant , Selfmanagement, Patient safety, Quality of life, Internet-interventions, Bloodpressure meter, Creatinine meter, Teleconsultation
- Inclusion criteria1. Kidney transplantation (living and deceased donor);
2. Age 18 years or above;
3. Good understanding of Dutch language (read/speak);
4. Access to broadband Internet;
5. Capable of performing requested actions autonomously.
- Exclusion criteria1. Combined transplantation (e.d. kidney-pancreas);
2. Poor understanding of sickness/therapy;
3. Mental retardation;
4. Proven noncompliance.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate31-dec-2014
- Target number of participants100
- InterventionsPatients in the intervention group receive a creatinine- and bloodpressure meter to measure creatinine and blood pressure at home. From week 7-52 after transplantation, half of policlinic visits will be replaced by telephonic consult in which values measured at home will be discussed.
The control group will receive care as usual.

During participation, patients in control and intervention group will complete a (psychological) questionnaire thrice.
- Primary outcome1. Safety and usability of disease management system;
2. Effectivity: Improvement of empowerment en quality of life when using disease management system / increase of patient knowledge as a consequence of education module of disease management system;
3. Psychological impact of using disease management system on patient and caregiver:
A. Increase/decrease of fear and/or other emotions;
B. Impact on relationship between patient and caregiver, e.g. more shared decision making.
- Secondary outcome1. User interface design factors of influence on safe and comfortable use of disease management system?
2. Possible problems and risks when using disease management system;
3. Improvement of system (based on experience);
4. Precision, accuracy and reliablity of creatinine meter in hands of patient;
5. Patient characteristics of influence on perceived usability of disease management system;
6. Effect of using disease management system on opinion about selfmanagement;
7. Implementation:
A. Development of model applicable to different patient groups;
B. Development of best practice for implementation of point of care creatinine meter.
- TimepointsJuly 2010: Start pilot;
March 2012: Start RCT;
April 2013: Last patient included;
April 2014: Stop follow-up;
December 2014: Project finished.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIn the current care process, renal transplant patients visit the out-patient clinic about 20 times during the first year after their transplantation. During these consultations, the level of creatinine in the blood and blood pressure as measured by the physician are the most important aspects to be managed. In the current project, we will allocate a part of the control to patients themselves by introducing a new home-based medical device for measuring the creatinine by a finger-prick, and by providing patients with options for home-based blood pressure measurements. Patients will measure their creatinine and blood pressure at home and will enter these results in a disease management system (DMS). Both patient and caregiver will have direct access to patients' measurements. Caregivers will be able to provide feedback either via DMS or by telephone.
- Main changes (audit trail)
- RECORD31-jul-2012 - 13-aug-2012

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