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NCT04435873 Clinical Trial

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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04435873
Other study ID # SP124 Home Experience
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 17, 2020
Est. completion date May 6, 2021

Study information
Verified date May 2021
Source Satellite Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 513
Est. completion date May 6, 2021
Est. primary completion date November 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Satellite WellBound of Austin Austin Texas
United States Satellite WellBound of South Austin Austin Texas
United States Satellite WellBound of Daly City Daly City California
United States Satellite Wellbound of Emeryville Emeryville California
United States Satellite Dialysis Folsom Folsom California
United States Satellite Wellbound of Fremont Fremont California
United States Satellite Healthcare Gilroy Gilroy California
United States Satellite Healthcare Larkspur Greenbrae California
United States Satellite Healthcare Laguna Hills Laguna Hills California
United States Satellite Healthcare Laredo South Laredo Texas
United States Satellite Wellbound of Memphis Memphis Tennessee
United States Satellite Healthcare Merced Merced California
United States Satellite WellBound of Milpitas Milpitas California
United States Satellite WellBound of Modesto Modesto California
United States Satellite WellBound of North Modesto Modesto California
United States Satellite WellBound of Mountain View Mountain View California
United States Satellite Healthcare Orange Orange California
United States Satellite Healthcare South Gate S. Gate California
United States Satellite Healthcare Sacramento Sacramento California
United States Satellite WellBound of Sacramento Sacramento California
United States Satellite WellBound of Sacramento University Sacramento California
United States Satellite Healthcare San Carlos San Carlos California
United States Satellite WellBound of San Francisco San Francisco California
United States Satellite WellBound of San Jose San Jose California
United States Satellite WellBound of San Leandro San Leandro California
United States Satellite WellBound of San Mateo San Mateo California
United States Satellite WellBound of Santa Cruz Santa Cruz California
United States Satellite WellBound of Santa Rosa Santa Rosa California
United States Satellite WellBound of Stockton Stockton California
United States Satellite Healthcare Tracy Tracy California
United States Satellite Healthcare Turlock West Turlock California
United States Satellite WellBound of Vallejo Vallejo California

Sponsors (2)
Lead Sponsor Collaborator
Satellite Healthcare University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the measurement model 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 Survey response rate Percent (%) of participants contacted who complete survey instrument through survey completion, an average of 6 months
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