Assessing Patient-Reported Experience of Care for Home Dialysis (ASPIRED)

November 30, 2021 updated by: Satellite Healthcare

Home dialysis modalities, including peritoneal dialysis (PD) and home hemodialysis (HHD), represent alternatives to conventional in-center hemodialysis (HD) that for some patients may be better aligned with preferences regarding the integration of dialysis treatments into their lives. Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. While validated instruments (ICH CAHPS) are in use to assess patient experience with in-center HD, currently no validated instruments are available to measure patient-reported experience in home dialysis.

This Home Patient Experience Survey Validation Study is an in-house research study conducted in partnership with the University of Washington.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Assessment of patient experience and satisfaction with care among individuals undergoing maintenance dialysis in the United States is a national health care priority and mandated by Congress. No validated instruments are available to measure the patient-reported experience of care in-home dialysis patients. Such tools are needed as more patients are expected to choose home dialysis therapies in the future. This study aims to validate a home patient experience survey instrument.

This is a cross-sectional validation to determine the measurement properties of a new home dialysis patient experience survey instrument. Satellite Healthcare home dialysis patients will be approached by mail or by phone to complete the survey.

The aim of this study is to perform field testing for this newly developed instrument for the purposes of instrument validation and to determine survey instrument measurement properties. This will include the evaluation of any multi-item scales as well as an overall score.

Study Type

Observational

Enrollment (Actual)

513

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Daly City, California, United States, 94014
        • Satellite WellBound of Daly City
      • Emeryville, California, United States, 94608
        • Satellite Wellbound of Emeryville
      • Folsom, California, United States, 95630
        • Satellite Dialysis Folsom
      • Fremont, California, United States, 94538
        • Satellite Wellbound of Fremont
      • Gilroy, California, United States, 95020
        • Satellite Healthcare Gilroy
      • Greenbrae, California, United States, 94904
        • Satellite Healthcare Larkspur
      • Laguna Hills, California, United States, 92653
        • Satellite Healthcare Laguna Hills
      • Merced, California, United States, 95384
        • Satellite Healthcare Merced
      • Milpitas, California, United States, 95035
        • Satellite WellBound of Milpitas
      • Modesto, California, United States, 95354
        • Satellite WellBound of Modesto
      • Modesto, California, United States, 95356
        • Satellite WellBound of North Modesto
      • Mountain View, California, United States, 94040
        • Satellite WellBound of Mountain View
      • Orange, California, United States, 92868
        • Satellite Healthcare Orange
      • S. Gate, California, United States, 90280
        • Satellite Healthcare South Gate
      • Sacramento, California, United States, 95821
        • Satellite WellBound of Sacramento
      • Sacramento, California, United States, 95825
        • Satellite WellBound of Sacramento University
      • Sacramento, California, United States, 95834
        • Satellite Healthcare Sacramento
      • San Carlos, California, United States, 94070
        • Satellite Healthcare San Carlos
      • San Francisco, California, United States, 94109
        • Satellite WellBound of San Francisco
      • San Jose, California, United States, 95125
        • Satellite WellBound of San Jose
      • San Leandro, California, United States, 94577
        • Satellite WellBound of San Leandro
      • San Mateo, California, United States, 94403
        • Satellite WellBound of San Mateo
      • Santa Cruz, California, United States, 95062
        • Satellite WellBound of Santa Cruz
      • Santa Rosa, California, United States, 95407
        • Satellite WellBound of Santa Rosa
      • Stockton, California, United States, 95219
        • Satellite WellBound of Stockton
      • Tracy, California, United States, 95377
        • Satellite Healthcare Tracy
      • Turlock, California, United States, 95380
        • Satellite Healthcare Turlock West
      • Vallejo, California, United States, 94590
        • Satellite WellBound of Vallejo
    • Tennessee
      • Memphis, Tennessee, United States, 38117
        • Satellite Wellbound of Memphis
    • Texas
      • Austin, Texas, United States, 78744
        • Satellite WellBound of South Austin
      • Austin, Texas, United States, 78758
        • Satellite WellBound of Austin
      • Laredo, Texas, United States, 78040
        • Satellite Healthcare Laredo South

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Target population is composed of those individuals receiving Home Dialysis care at Satellite Healthcare facilities,

Description

Inclusion Criteria:

  • Patients receiving care for home dialysis at a facility that provides care for >= 3 patients at the time of cohort identification.

Exclusion Criteria:

  • Age < 18 years
  • Patients receiving care for home dialysis at the facility for less than 3 months
  • Institutionalized (senior nursing facility/multi-resident facility) or Hospice care patients

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mail Survey Participants
Approximately 1200 home patients will receive mail surveys. Of these, one thousand and twenty (1,020) patients will be asked to complete the survey once. One hundred and eighty (180) patients will be asked to complete the survey twice.
Other: Survey using "Your Home Dialysis Care Experience" tool.
Validation of a new survey instrument to capture the experience of care by home dialysis patients.
Telephone Survey Participants
Three hundred (300) home patients will be surveyed by phone. Of those, one hundred and twenty will be asked to complete the survey once. One hundred and eighty patients will be asked to complete the phone surveys on two separate occasions.
Other: Survey using "Your Home Dialysis Care Experience" tool.
Validation of a new survey instrument to capture the experience of care by home dialysis patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the measurement model
Time Frame: through survey completion, an average of 6 months
The evaluation will encompass the survey burden, presence of a floor or ceiling effect for any item, test-retest reliability, development of multi-item subscales, internal consistency and reliability, center level reliability of the items and composites, and construct validity.
through survey completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey response rate
Time Frame: through survey completion, an average of 6 months
Percent (%) of participants contacted who complete survey instrument
through survey completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Satellite Healthcare

Collaborators

University of Washington

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 17, 2020

Primary Completion (ACTUAL)

November 2, 2020

Study Completion (ACTUAL)

May 6, 2021

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (ACTUAL)

June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP124 Home Experience

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A de-identified data set of responses will be shared with the Kidney Research Institute at the University of Washington.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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