Chronic Kidney Disease Clinical Trial
— HOPEOfficial title:
Health Outcomes Patient Education
NCT number | NCT02976220 |
Other study ID # | 16-19626 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | October 2017 |
Verified date | March 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco VA Medical Center: Clinical Research Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Cricket Health |
United States,
Devins GM, Mendelssohn DC, Barré 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. — View Citation
Devins GM, Mendelssohn DC, Barré 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. — View Citation
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. — View Citation
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. Review. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | General Knowledge | 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 | |
Secondary | Modality Knowledge | 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 | |
Secondary | Self-efficacy | 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 |
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