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Health Outcomes Patient Education (HOPE)

7. mars 2022 oppdatert av: University of California, San Francisco
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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

25

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • San Francisco, California, Forente stater, 94121
        • San Francisco VA Medical Center: Clinical Research Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 90 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Digital Education
1 month digital education program
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care
Tidsramme: 1 month
Number 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.
1 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
General Knowledge
Tidsramme: 1 month
This 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.
1 month
Modality Knowledge
Tidsramme: 1 month
This 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.
1 month
Self-efficacy
Tidsramme: 1 month
This 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.
1 month

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Ruth Dubin, MD, University of California, San Francisco

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2016

Primær fullføring (Faktiske)

1. oktober 2017

Studiet fullført (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først innsendt

28. september 2016

Først innsendt som oppfylte QC-kriteriene

23. november 2016

Først lagt ut (Anslag)

29. november 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 16-19626

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ubestemt

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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