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This project is aimed to analyze the current models and to design innovative strategies to improve quality of care and optimise resource utilization of telemedicine (TM) in home-based management for the global care of patients with chronic kidney diseases (CKD). The main focus is on the prevention of complications, recurrence of unstabilization and optimal therapy for the global management of chronic pts through TM and e-Health. Reducing avoidable/unnecessary hospitalisation of pts with chronic conditions, through the effective implementation of a health care network, offering integrated care programs and applying chronic disease management models, should ultimately contribute to the improved efficiency of health systems.
The investigators will design, test and evaluate innovative models for applying TM to the management of pts with chronic kidney diseases .
New models will be characterized by the followings:
Finally, the investigators will collect a set of data allowing to analyse and validate the care model and to measure the patient adherence to the care plan as well as measure the performance of the predictive models based on this data.
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline number of days of hospitalization at 6 and 12 months | A comparison among the baseline number of days of hospitalization and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems | Baseline, 6 months and 12 months |
| Change from baseline number of home visits by the doctor at 6 and 12 months | A comparison among the baseline number of home visits by the doctor and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems | Baseline, 6 months and 12 months |
| Change from baseline number of doctor's office visits at 6 and 12 months | A comparison among the baseline number of doctor's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems | Baseline, 6 months and 12 months |
| Change from Baseline number of nephrologist's office visits at 6 and 12 months | A comparison among the baseline number of nephrologist's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems | Baseline, 6 months and 12 months |
| Change from baseline Dialyzer clearance of urea multiplied by dialysis time and normalized for urea distribution volume (Kt/V) at 6 and 12 months | A comparison among the baseline Kt/V and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows | Baseline, 6 months and 12 months |
| Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 months |
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Inclusion Criteria for Peritoneal dialysis (PD) patients:
Inclusion Criteria for Hemodialysis (HD) patients:
Inclusion Criteria for Chronic nephropathic patients undergoing predialysis:
Exclusion Criteria:
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We propose to consider 3 case studies: 2 patients on peritoneal dialysis , 2 patients on home hemodialysis and 4 patients attending pre-dialysis clinic .
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Bianchi, MD | Azienda Sanitaria Nord Ovest Toscana Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria NordOvest Toscana | Livorno | Tuscany | 57100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36630403 | Background | Young A, Orchanian-Cheff A, Chan CT, Wald R, Ong SW. Video-Based Telemedicine for Kidney Disease Care: A Scoping Review. Clin J Am Soc Nephrol. 2021 Dec;16(12):1813-1823. doi: 10.2215/CJN.06660521. Epub 2021 Dec 7. | |
| 33544863 | Background | Lindeboom L, Lee S, Wieringa F, Groenendaal W, Basile C, van der Sande F, Kooman J. On the potential of wearable bioimpedance for longitudinal fluid monitoring in end-stage kidney disease. Nephrol Dial Transplant. 2022 Oct 19;37(11):2048-2054. doi: 10.1093/ndt/gfab025. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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A comparison among the baseline eGFR and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows |
| Baseline, 6 months and 12 months |
| Change from baseline Hb at 6 and 12 months | A comparison among the baseline Hb and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows | Baseline, 6 months and 12 months |
| Change from baseline Ca/P at 6 and 12 months | A comparison among the baseline Ca/P and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows | Baseline, 6 months and 12 months |
| Change from baseline Parathyroid hormone (PTH) levels at 6 and 12 months | A comparison among the baseline PTH and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows | Baseline, 6 months and 12 months |
| Change from baseline Average weight loss in HD/PD at 6 and 12 months | A comparison among the baseline Average weight loss in HD/PD and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record | Baseline, 6 months and 12 months |
| Change from baseline Weight at 6 and 12 months | A comparison among the baseline Weight and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record | Baseline, 6 months and 12 months |
| Change from baseline HD complications at 6 and 12 months | A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record | Baseline, 6 months and 12 months |
| Change from baseline PD complications at 6 and 12 months | A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record | Baseline, 6 months and 12 months |
| Change from baseline Total number of prescribed drugs at 6 and 12 months | A comparison among the baseline Total number of prescribed drugs and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record | Baseline, 6 months and 12 months |
| Change from 6 months Satisfaction score of the system at 12 months (5-level scale) | A comparison between the overall satisfaction rating of the system at 6 and 12 months will be carried out. A 5-level scale is used (interval scale: 1 to 5): 1=Very Unsatisfied, 2= Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Information collected through a specific questionnaire. | 6 months and 12 months |
| Change from 6 months Usability index of the system at 12 months | A comparison between the Usability rating of the whole system and of the individual devices at 6 and 12 months will be carried out. Information collected through a specific questionnaire. | 6 months and 12 months |
| Change from 6 months Time acceptability index at 12 months | A comparison between the Patients' acceptance of the time required for the system daily usage at 6 and 12 months will be carried out. Information collected through a specific questionnaire. | 6 months and 12 months |
| Change from 6 months Acceptance of a potential systematic usage at 12 months | A comparison between the Patients' acceptance of a potential systematic usage of the system at 6 and 12 months will be carried out. Information collected through a specific questionnaire. | 6 months and 12 months |
| Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) | Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with. Data will extracted from the system service platform. | 12 months |
| Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient | Total number of measurements performed by each patient through the devices he is equipped with. The measurements include the following parameters: systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis parameters. Data will extracted from the system service platform. | 12 months |
| Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) | Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with. Data will extracted from the system service platform. | 12 months |
| Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient | Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by each patient through the devices he is equipped with. Data will extracted from the system service platform. | 12 months |
| 36286261 | Background | Gc VS, Iglesias CP, Erdem S, Hassan L, Peek N, Manca A. Using discrete-choice experiments to elicit preferences for digital wearable health technology for self-management of chronic kidney disease. Int J Technol Assess Health Care. 2022 Oct 26;38(1):e77. doi: 10.1017/S0266462322003233. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |