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

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.

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Key information

Conditions

Home Dialysis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Satellite WellBound of Daly City, Daly City, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey using "Your Home Dialysis Care Experience" tool.

Other

Validation of a new survey instrument to capture the experience of care by home dialysis patients.

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

Time frame: through survey completion, an average of 6 months

Percent (%) of participants contacted who complete survey instrument

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Collaborators

University of Washington

Registry information

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jun 17, 2020
Registry last updated: Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed