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

NCT ID: NCT05906927

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-09-30

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role: lead

Responsible Party

Roberto Bigazzi

Emeritus Director of Operational Unit of Nephrology and Dialysis

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Bianchi, MD

Role: STUDY_CHAIR

Azienda Sanitaria Nord Ovest Toscana Italy

Locations

Azienda Sanitaria NordOvest Toscana

Livorno, Tuscany, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 36630403 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33544863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36286261 (View on PubMed)

Other Identifiers

Telemechron WP1-40/2019

Identifier Type: -

Identifier Source: org_study_id