Health Outcomes Patient Education

NCT02976220 | Completed

• 1 other identifier: 16-19626
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; End-Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care

  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

Secondary Outcomes (3)

• General Knowledge

  1 month

• Modality Knowledge

  1 month

• Self-efficacy

  1 month

Study Arms (1)

Digital Education

EXPERIMENTAL

1 month digital education program

Other: Digital Education

Interventions

Digital Education OTHER

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.

Digital Education

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Cricket Health: collaborator

Study Sites (1)

San Francisco VA Medical Center: Clinical Research Center

San Francisco, California, 94121, United States

Location

Related Publications (6)

• Devins GM, Mendelssohn DC, Barre PE, Binik YM. Predialysis psychoeducational intervention and coping styles influence time to dialysis in chronic kidney disease. Am J Kidney Dis. 2003 Oct;42(4):693-703. doi: 10.1016/s0272-6386(03)00835-7.

  PMID: 14520619 BACKGROUND

• Mason J, Khunti K, Stone M, Farooqi A, Carr S. Educational interventions in kidney disease care: a systematic review of randomized trials. Am J Kidney Dis. 2008 Jun;51(6):933-51. doi: 10.1053/j.ajkd.2008.01.024. Epub 2008 Apr 28.

  PMID: 18440681 BACKGROUND

• Manns BJ, Taub K, Vanderstraeten C, Jones H, Mills C, Visser M, McLaughlin K. The impact of education on chronic kidney disease patients' plans to initiate dialysis with self-care dialysis: a randomized trial. Kidney Int. 2005 Oct;68(4):1777-83. doi: 10.1111/j.1523-1755.2005.00594.x.

  PMID: 16164654 BACKGROUND

• U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013.

  BACKGROUND

• Devins GM, Mendelssohn DC, Barre PE, Taub K, Binik YM. Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up. Am J Kidney Dis. 2005 Dec;46(6):1088-98. doi: 10.1053/j.ajkd.2005.08.017.

  PMID: 16310575 BACKGROUND

• Dubin R, Rubinsky A. A Digital Modality Decision Program for Patients With Advanced Chronic Kidney Disease. JMIR Form Res. 2019 Feb 6;3(1):e12528. doi: 10.2196/12528.

  PMID: 30724735 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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 Officials

• Ruth Dubin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

US (1)