Chronic Kidney DiseaseHOPENCT02976220
Health Outcomes Patient Education
A study testing Digital Education in people with Chronic Kidney Disease and End-Stage Renal Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease
- What is being tested?
- Digital Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Dementia
- Severe cognitive impairment
- Blindness
- Deafness
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center: Clinical Research Center
San Francisco, California, 94121
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Being tested
- Digital Education
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Education | Experimental | 1 month digital education program Receives: Other: Digital Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Cricket Health
- Responsible party
- Sponsor
- Investigators
- Ruth Dubin, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976220
- Sponsor's protocol ID
- 16-19626
- Acronym
- HOPE
- Status last verified
- Mar 2022
- First submitted
- 28 Sep 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14520619Mason 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.
PubMed 18440681Manns 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.
PubMed 16164654U.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.
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.
PubMed 16310575Dubin 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.
PubMed 30724735
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes Patient Education
- ClinicalTrials.gov ID
- NCT02976220
- Acronym / sponsor ID
- HOPE / 16-19626
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Cricket Health
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Education | Experimental | Other: Digital Education1 month digital education program |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital EducationOnline 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. | Other | Digital Education |
Primary outcome
Number of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care
Time frame: 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.
3 secondary outcomes
General Knowledge
Time frame: 1 month
Modality Knowledge
Time frame: 1 month
Self-efficacy
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Background: PubMed 14520619Devins 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.
- Background: PubMed 18440681Mason 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.
- Background: PubMed 16164654Manns 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.
- BackgroundU.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: PubMed 16310575Devins 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.
- Derived from this study: PubMed 30724735Dubin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Dubin, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Education in people with Chronic Kidney Disease and End-Stage Renal Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who feel ready to choose a treatment option from among home hemodialysis, in-center hemodialysis, peritoneal dialysis or conservative care (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02976220, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.