Home With TablO outcoMEs (HOME) Registry (HOME)

September 22, 2022 updated by: Outset Medical
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Recruiting
        • Satellite Healthcare, Inc.
        • Contact:
          • Kshama Mehta
        • Principal Investigator:
          • Wael Hussein, MD
      • Victorville, California, United States, 92395
        • Completed
        • Desert Cities Dialysis
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Recruiting
        • Berkshire Medical Center
        • Contact:
          • Tammy Bator, RN
        • Principal Investigator:
          • David Henner, M.D.
    • Montana
      • Helena, Montana, United States, 59601
        • Recruiting
        • St. Peter's Health
        • Contact:
          • Alice Luehr
        • Principal Investigator:
          • Robert LaClair, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68512
        • Recruiting
        • Dialysis Center of Lincoln
        • Contact:
          • Corinne Morehead
        • Principal Investigator:
          • Matt Glathar, MD
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Parker Jewish Institute
        • Contact:
          • Alana Doonacher
        • Principal Investigator:
          • Sayed Ali, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Grossman School of Medicine
        • Contact:
          • Paula Dutka
      • New York, New York, United States, 10021
        • Recruiting
        • Rogosin Institute
        • Principal Investigator:
          • Frank Liu, MD
        • Contact:
          • Kimberly Davis
    • Texas
      • Plano, Texas, United States, 75024
        • Recruiting
        • USRC Kidney Research
        • Contact:
          • Stephanie Brillhart, MSCI
        • Principal Investigator:
          • Geoff Block, MD
    • Virginia
      • Staunton, Virginia, United States, 24401
        • Withdrawn
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.

Description

Inclusion Criteria:

  • Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
  • Participant weighs ≥ 34kg.
  • Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
  • Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
  • Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.

Exclusion Criteria:

  • Participant and/or care partner is unable to read English or Spanish.
  • Participant has a home environment that is deemed inappropriate for home dialysis.
  • Participant and/or care partner is unable to successfully complete the Tablo training program
  • Participant is pregnant or plans to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tablo Hemodialysis System
Home dialysis treatment with the Tablo Hemodialysis System
Device: Tablo Hemodialysis System
Home hemodialysis treatments ~4 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly Standardized Dialysis Adequacy
Time Frame: 12-months
Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
12-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Outcomes
Time Frame: Change from Baseline at 12-months
Change in health outcomes from baseline to 12-months, as measured by the 12-item Short Form Health Survey (SF-12) Questionnaire. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100. Higher scores mean a better outcome.
Change from Baseline at 12-months
Sleep Outcomes
Time Frame: Change from Baseline at 12-months
Change in sleep from baseline to 12-months, as measured by the Insomnia Severity Index (ISI). The minimum and maximum values are 0 and 28 scores, respectively. Higher scores mean a worse outcome.
Change from Baseline at 12-months
Care Partner Burden
Time Frame: Change from Baseline at 12-months
Change in care partner burden from baseline to 12-months, as measured by the Zarit Burden Interview-12 (ZBI-12) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating a worse outcome.
Change from Baseline at 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Outset Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

August 14, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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