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Health Outcomes Patient Education

Health Outcomes Patient Education

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02976220
Acronym
HOPE
Enrollment
25
Registered
2016-11-29
Start date
2016-11-30
Completion date
2017-10-31
Last updated
2022-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, End-Stage Renal Disease

Brief summary

This study is designed to evaluate the feasibility of using digital-enabled education in clinical care in order to improve patient outcomes related to end-stage renal disease (ESRD). If effective, educational interventions could be used to improve the long-term survival of patients with chronic kidney disease (CKD) and to make clinical care for these patients more cost effective.

Detailed description

Studies have shown that educational interventions in patients nearing end-stage renal disease (ESRD) can delay the need for dialysis and increase the likelihood of the patient choosing in-home vs. in-center dialysis. Given the higher cost of in-center hemodialysis compared to in-home strategies, such as peritoneal dialysis, efforts at increasing use of in-home dialysis modalities are likely to be cost-effective. Moreover, while few studies of educational interventions have long-term follow-up, one study suggests that patients exposed to educational interventions have improved long-term survival once on dialysis. The long-term goal is to improve clinical and patient-centered outcomes in patients transitioning from Chronic Kidney Disease Stage (CKD) IV and V to dialysis-requiring ESRD. The short-term goal of this pilot project is to evaluate the feasibility of delivering digital-enabled ESRD education to patients with CKD stage IV and V (eGFR\<30ml/min/1.73m2, not yet on dialysis) in clinical care. The investigators will provide this education in the form of in-person nurse advice, online digital content including videos, and online messaging with a nurse, moderated patient group and peer mentor. The main objective of the educational program will be to 1) Increase awareness of options, 2) Prioritize options based on patient lifestyle and values, 3) Build confidence in modality decision. The investigators will develop individualized, digitalized educational content (which includes videos, text and illustration) for patients with CKD that will increase awareness of ESRD care options including in-home hemodialysis, peritoneal dialysis and choosing not to have dialysis. Patients will enroll in a month-long program during which they have access to the educational app, including lifestyle and modality educational content and online messaging where they can access a nurse for 1 on 1 discussion, a patient mentor for 1 on 1 discussion, and a patient group for group mentorship exercises. The investigators will pilot these materials in patients at high risk of progression to dialysis and evaluate the primary outcomes of whether they were able to complete the program and make a modality choice. Secondary outcomes will include assessments to determine the intervention's impact on patient dialysis modality awareness and likelihood of choosing a home-dialysis modality. At the end of the study, the investigators will provide an insights report to the study participants' doctors and survey the doctors to ascertain their perspectives on the usefulness of the educational program for their patients' care.

Interventions

Online videos, illustrations, and text materials designed to improve participants' awareness and understanding of kidney function, kidney disease, kidney failure options, peritoneal dialysis, home hemodialysis, in-center hemodialysis, kidney transplant, medical management, and treatment decision. Also includes online messaging system and discussion board designed to allow participants to message study nurse and peer mentor, as well as to engage in group discussion in an open forum and about specific scenarios.

Sponsors

Cricket Health
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No

Inclusion criteria

* eGFR \< 30ml/min/1.73m² * Regular attendance at the nephrology clinic; at least two visits within the last 18 months * Clinic notes indicate patient has had discussion with a nephrologist regarding needing dialysis in the future

Exclusion criteria

* Homelessness * Non-English speaking * No phone or no internet access on one of the following: smart phone, tablet, or computer * No e-mail access * Age ≥ 90 years * Hospitalized more than twice during the last 6 months * Dementia * Severe cognitive impairment * Blindness * Deafness

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care1 monthNumber of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care. Unit of measure: the change from pre- to post-educational program, # participants.

Secondary

MeasureTime frameDescription
General Knowledge1 monthThis questionnaire will include multiple choice questions designed to show if the patient gained general knowledge about kidney disease from the education program. Unit of measure: the change from pre- to post-educational program in per cent of questions each patient answered correctly.
Modality Knowledge1 monthThis questionnaire will include multiple choice questions designed to show if the patient understands the different options of care for end-stage renal disease, including home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care. Unit of measure: the change from pre- to post-educational program in per cent of questions each patient answered correctly.
Self-efficacy1 monthThis survey consists of five questions drawn from validated surveys of self-efficacy in the chronic kidney disease population. Unit of measure: Each question is answered on a likert scale 1-5. Total score ranges from 5 to 25. Unit of measure is change in overall likert rating for each participant from pre- and post-educational program.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026