Recruiting

Optimal Transition

Sponsor:

Satellite Healthcare

Code:

NCT04263233

Conditions

ESRD

Hemodialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Analysis using descriptive statistics of patient clinical outcomes.

Surveys with participants using validated survey tools.

Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.

Study Details

Brief summary:

This is an evaluation of a program developed by a team of nephrologists, operations experts and researchers. The goal is to provide CKD patients with a better way to transition to life on dialysis - one that emphasizes even more individual clinical, psychosocial and lifestyle needs. On top of high-quality clinical care, the 4-week Optimal Transition program supports patients as they adjust to treatment and learn to live the best life possible. This is done through a robust education curriculum and a trust-building approach.

Conditions

ESRD

Hemodialysis

Study ID

NCT04263233

Start date

Jan 29, 2020

Status verified date

Sep, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Jul 28, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Referred for incenter hemodialysis at one of two Satellite Healthcare (SHC) participating dialysis units
  • Without significant cognitive impairment;
  • Able to meaningfully interact with staff; and
  • Fluent in English (due to education material being limited to English at this time).

Exclusion Criteria:

  • Unable to meaningfully interact with staff;
  • Unable to read and understand English; or
  • Has significant cognitive impairment per the nephrologist or Principal Investigator

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Other

This program, which is provided for all patients new to dialysis at the participating units, will be evaluated by assessing patient clinical outcomes and the results of surveys measuring patient-reported symptoms, quality of life, knowledge and activation. In addition, satisfaction with the program will be assessed.

Interventions

Analysis using descriptive statistics of patient clinical outcomes.

Evaluation of the following:

  • Laboratory values at admission, week 4, and day 90.
  • Pre and post blood pressure at week one and week 4.
  • Intradialytic hypotension at week one and week 4.
  • Ultrafiltration rates at week one, week 4, day 90, day 180, and day 360.
  • Target weight defined and achievement in week one and week 4 and changes between week one and week 4.
  • Dialysis access type at week one and day 90.
  • Hospitalization and mortality rates.

Surveys with participants using validated survey tools.

Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.

Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.

Data will be collected using tracking tools throughout the program.

Primary outcome measure

  • Evaluation of clinical stabilization through standard clinical dialysis labs [ Time Frame: On admission, week 4 and day 90 ]
  • Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurements [ Time Frame: At week one and week 4. ]
  • Evaluation of clinical stabilization through standard clinical dialysis measurements of Intradialytic blood pressures [ Time Frame: At week one and week 4. ]
  • Evaluation of clinical stabilization through standard clinical dialysis measurements of ultrafiltration [ Time Frame: At week one, week 4, day 90, day 180 and day 360. ]
  • Evaluation of clinical stabilization through standard clinical dialysis measurements of weight [ Time Frame: At week one and week 4, and changes between week one and week 4. ]
  • Evaluation of clinical stabilization through standard clinical dialysis measurements [ Time Frame: At week one and day 90 ]
  • Evaluation of clinical stabilization through standard clinical dialysis collection of patient hospitalizations. [ Time Frame: Day 30, day 90, 6 months and 12 months ]
  • Evaluation of clinical stabilization through standard clinical dialysis records. [ Time Frame: Day 30, day 90, 6 months and 12 months ]
  • Evaluation of clinical and psychological stabilization through a quality of life measurement. [ Time Frame: Week 4 ]
  • Evaluation of clinical and psychological stabilization through assessment of patient symptoms. [ Time Frame: Week 1 and Week 4 ]
  • Satisfaction with the modality options education [ Time Frame: Week 1 and Week 4 ]
  • Type of Dialysis Modality chosen by the patient [ Time Frame: Week 1 and Week 4 ]
  • Actual Type of Dialysis Modality used by the patient [ Time Frame: week 4, month 3, 6, 12, 18 and 24 ]
  • Evaluation of patient knowledge of dialysis and modalities [ Time Frame: Week 1, 2, 3, 4 ]
  • Evaluation of patient activation [ Time Frame: Week 3 and month 3 ]
  • Evaluation of patient satisfaction [ Time Frame: Week 4 or discharge from the program whichever comes first ]
  • Evaluation of the program process for time utilization [ Time Frame: Week 1 through week 4 ]
  • Evaluation of the program process for cost utilization [ Time Frame: Week 1 through week 4 ]
  • Evaluation of the feasibility of the program [ Time Frame: Week 1 through week 4 ]
  • Evaluation of the program efficiency [ Time Frame: Week 1 through week 4 ]

Central Contacts and Locations

Central contacts

Jug Atwal

650-404-3606atwalJ@satellitehealth.com

Legg Veronica, M.S.

650-404-3736leggv@satellitehealth.com

Locations

Satellite Healthcare Oakland

Recruiting

Oakland, California, United States, 94609

Satellite Healthcare Sacramento

Recruiting

Sacramento, California, United States, 95834

Satellite Healthcare Chickasaw Gardens

Recruiting

Memphis, Tennessee, United States, 38111

More Information

Sponsor

Satellite Healthcare

Last update posted

Sep 22, 2021

Last verified

Sep, 2021

Keywords

  • ESRD
  • Hemodialysis
  • Education
  • Evaluation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Satellite Healthcare on 2021-09-22.