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

Assessment of a Disease Management system with medical devices In REnal disease.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27598
Enrollment
100
Registered
2012-07-31
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney, nier, kidney transplantation, niertransplantatie, renal transplantation, self-management, zelfmanagement, patient empowerment, patient safety, patientveiligheid, quality of life, kwaliteit van leven, disease management system, ziektemanagement systeem, web-based utility, virtual coaching, medical device, creatinine meter, kreatininemeter, blood pressure meter, bloeddrukmeter, extramural care, extramurale zorg, tele-care, home-care.

Interventions

Patients 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

Sponsors

Performer: Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. Combined transplantation (e.d. kidney-pancreas); 2. Poor understanding of sickness/therapy; 3. Mental retardation; 4. Proven noncompliance.

Design outcomes

Primary

MeasureTime frame
1. 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

MeasureTime frame
1. 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.

Contacts

Public ContactC. Lint, van

Leids Universitair Medisch Centrum Albinusdreef 2

c.l.van_lint@lumc.nl+31 (0)71 5262148

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)