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

NCT04435873 | Completed

• 1 other identifier: SP124 Home Experience
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 32

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.

Conditions

Home Dialysis; End Stage Renal Disease

Keywords

ESRD; Dialysis; Patient Experience; Home Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Survey response rate

  through survey completion, an average of 6 months

Study Arms (2)

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.

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.

Interventions

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.

Mail Survey Participants; Telephone Survey Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Satellite Healthcare: lead
• University of Washington: collaborator

Study Sites (32)

Satellite WellBound of Daly City

Daly City, California, 94014, United States

Location

Satellite Wellbound of Emeryville

Emeryville, California, 94608, United States

Location

Satellite Dialysis Folsom

Folsom, California, 95630, United States

Location

Satellite Wellbound of Fremont

Fremont, California, 94538, United States

Location

Satellite Healthcare Gilroy

Gilroy, California, 95020, United States

Location

Satellite Healthcare Larkspur

Greenbrae, California, 94904, United States

Location

Satellite Healthcare Laguna Hills

Laguna Hills, California, 92653, United States

Location

Satellite Healthcare Merced

Merced, California, 95384, United States

Location

Satellite WellBound of Milpitas

Milpitas, California, 95035, United States

Location

Satellite WellBound of Modesto

Modesto, California, 95354, United States

Location

Satellite WellBound of North Modesto

Modesto, California, 95356, United States

Location

Satellite WellBound of Mountain View

Mountain View, California, 94040, United States

Location

Satellite Healthcare Orange

Orange, California, 92868, United States

Location

Satellite WellBound of Sacramento

Sacramento, California, 95821, United States

Location

Satellite WellBound of Sacramento University

Sacramento, California, 95825, United States

Location

Satellite Healthcare Sacramento

Sacramento, California, 95834, United States

Location

Satellite Healthcare San Carlos

San Carlos, California, 94070, United States

Location

Satellite WellBound of San Francisco

San Francisco, California, 94109, United States

Location

Satellite WellBound of San Jose

San Jose, California, 95125, United States

Location

Satellite WellBound of San Leandro

San Leandro, California, 94577, United States

Location

Satellite WellBound of San Mateo

San Mateo, California, 94403, United States

Location

Satellite WellBound of Santa Cruz

Santa Cruz, California, 95062, United States

Location

Satellite WellBound of Santa Rosa

Santa Rosa, California, 95407, United States

Location

Satellite Healthcare South Gate

South Gate, California, 90280, United States

Location

Satellite WellBound of Stockton

Stockton, California, 95219, United States

Location

Satellite Healthcare Tracy

Tracy, California, 95377, United States

Location

Satellite Healthcare Turlock West

Turlock, California, 95380, United States

Location

Satellite WellBound of Vallejo

Vallejo, California, 94590, United States

Location

Satellite Wellbound of Memphis

Memphis, Tennessee, 38117, United States

Location

Satellite WellBound of South Austin

Austin, Texas, 78744, United States

Location

Satellite WellBound of Austin

Austin, Texas, 78758, United States

Location

Satellite Healthcare Laredo South

Laredo, Texas, 78040, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: July 17, 2020
• Primary Completion: November 2, 2020
• Study Completion: May 6, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-05

Locations

US (32)