Clinical trial NCT05906927: Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities (NET-2018-12367206)
Official title: Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities: Analysis of Current Models and Design of Innovative Strategies to Improve Quality of Care and Optimise Resource Utilization
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: Azienda USL Toscana Nord Ovest
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We propose to consider 3 case studies: 2 patients on peritoneal dialysis , 2 patients on home hemodialysis and 4 patients attending pre-dialysis clinic .

Brief summary: 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.

Detailed description: 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:

* flexible adaptation to pts subgroups/ individual pts characteristics, including pts (and caregivers) expectation and willingness to participate actively in the process of care
* identification of technical components which are essential, accessory, useful or futile for different pts subgroups, including evaluation of pts abilities and preferences.
* definition of the team of care and the roles and responsibilities of each components: case manager, clinical manager etc
* pre-definition of outcome measures, that should include at least the evaluation of quality of life, perceived quality of care by the pts and caregivers, number and duration of hospitalizations.
* definition of Quality Assurance (QA) derived indicators related to risk and performance of TM implementation where needed

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.

Eligibility criteria: Inclusion Criteria for Peritoneal dialysis (PD) patients:

* patients already on treatment both in continuous home peritoneal dialysis (CAPD) and patients in nocturnal automated peritoneal dialysis (IPD)
* autonomous in their management of dialysis therapy,
* absence of acute or rapidly disabling comorbidities,
* ability to use a smart phone,
* home covered by fast optical fiber

Inclusion Criteria for Hemodialysis (HD) patients:

* Patients already in treatment, autonomous in their management of home dialysis therapy, or in dialysis at peripheral centers where the continuous presence of the nephrologist is not guaranteed
* Absence of acute or rapidly disabling comorbidities,
* Presence of a stable and well-functioning vascular access for hemodialysis,
* Ability to use a smart phone,
* Home covered by fast optical fiber

Inclusion Criteria for Chronic nephropathic patients undergoing predialysis:

* Patients already taken care of by the facility,
* Absence of acute or rapidly disabling comorbidities,
* Ability to use a smart phone,
* Home covered by fast optical fiber

Exclusion Criteria:

* History of malignant hypertension or accelerated hypertension within 6 months prior to study entry.
* History of drugs i.v. or alcohol abuse. History of cocaine abuse will be an exclusion criterion.
* Serious systemic disease that could affect the survival or course of the kidney disease.
* Body mass index greater than 35 Kg/m2 in men and 33 Kg/m2 in women. BMI is calculated as weight (kg)/height (m2).
* Myocardial infarction or cerebrovascular accident in the past 6 months
* Pregnancy or likelihood of becoming pregnant during the study period.
* Using nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 1 week/month, excluding baby aspirin.
* Suspect that the participant will not be able to meet the protocol visits schedule.

Primary outcomes:
measure: Change from baseline number of days of hospitalization at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline number of home visits by the doctor at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline number of doctor's office visits at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from Baseline number of nephrologist's office visits at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Dialyzer clearance of urea multiplied by dialysis time and normalized for urea distribution volume (Kt/V) at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Hb at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Ca/P at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Parathyroid hormone (PTH) levels at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Average weight loss in HD/PD at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Weight at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline HD complications at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline PD complications at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from baseline Total number of prescribed drugs at 6 and 12 months
timeFrame: Baseline, 6 months and 12 months
measure: Change from 6 months Satisfaction score of the system at 12 months (5-level scale)
timeFrame: 6 months and 12 months
measure: Change from 6 months Usability index of the system at 12 months
timeFrame: 6 months and 12 months
measure: Change from 6 months Time acceptability index at 12 months
timeFrame: 6 months and 12 months
measure: Change from 6 months Acceptance of a potential systematic usage at 12 months
timeFrame: 6 months and 12 months
measure: Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
timeFrame: 12 months
measure: Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
timeFrame: 12 months
measure: Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
timeFrame: 12 months
measure: Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Livorno
country: Italy
facility: Azienda Sanitaria NordOvest Toscana
state: Toscana
Study officials:
affiliation: Azienda Sanitaria Nord Ovest Toscana Italy
name: Stefano Bianchi, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.