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Clinical Trials/NCT04435873
NCT04435873
Completed
Not Applicable

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

Satellite Healthcare32 sites in 1 country513 target enrollmentJuly 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Home Dialysis
Sponsor
Satellite Healthcare
Enrollment
513
Locations
32
Primary Endpoint
Evaluation of the measurement model
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2020
End Date
May 6, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Survey response rate(through survey completion, an average of 6 months)

Study Sites (32)

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