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

NCT05906927 | Unknown

• 1 other identifier: Telemechron WP1-40/2019
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (22)

• 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

  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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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

You may not qualify if:

• History of malignant hypertension or accelerated hypertension within 6 months prior to study entry.
• 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.

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead

Study Sites (1)

Azienda Sanitaria NordOvest Toscana

Livorno, Tuscany, 57100, Italy

Location

Related Publications (3)

• 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.

  PMID: 36630403 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.

  PMID: 33544863 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.

  PMID: 36286261 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Bianchi, MD

  Azienda Sanitaria Nord Ovest Toscana Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Director of Operational Unit of Nephrology and Dialysis

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: June 18, 2023
• Study Start: August 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)