Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities (NET-2018-12367206) (Telemechron)

Azienda USL Toscana Nord Ovest

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT05906927

Telemechron WP1-40/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.