<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02976220</url>
  </required_header>
  <id_info>
    <org_study_id>16-19626</org_study_id>
    <nct_id>NCT02976220</nct_id>
  </id_info>
  <brief_title>Health Outcomes Patient Education</brief_title>
  <acronym>HOPE</acronym>
  <official_title>Health Outcomes Patient Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cricket Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the feasibility of using digital-enabled education in&#xD;
      clinical care in order to improve patient outcomes related to end-stage renal disease (ESRD).&#xD;
      If effective, educational interventions could be used to improve the long-term survival of&#xD;
      patients with chronic kidney disease (CKD) and to make clinical care for these patients more&#xD;
      cost effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that educational interventions in patients nearing end-stage renal disease&#xD;
      (ESRD) can delay the need for dialysis and increase the likelihood of the patient choosing&#xD;
      in-home vs. in-center dialysis. Given the higher cost of in-center hemodialysis compared to&#xD;
      in-home strategies, such as peritoneal dialysis, efforts at increasing use of in-home&#xD;
      dialysis modalities are likely to be cost-effective. Moreover, while few studies of&#xD;
      educational interventions have long-term follow-up, one study suggests that patients exposed&#xD;
      to educational interventions have improved long-term survival once on dialysis.&#xD;
&#xD;
      The long-term goal is to improve clinical and patient-centered outcomes in patients&#xD;
      transitioning from Chronic Kidney Disease Stage (CKD) IV and V to dialysis-requiring ESRD.&#xD;
      The short-term goal of this pilot project is to evaluate the feasibility of delivering&#xD;
      digital-enabled ESRD education to patients with CKD stage IV and V (eGFR&lt;30ml/min/1.73m2, not&#xD;
      yet on dialysis) in clinical care. The investigators will provide this education in the form&#xD;
      of in-person nurse advice, online digital content including videos, and online messaging with&#xD;
      a nurse, moderated patient group and peer mentor. The main objective of the educational&#xD;
      program will be to 1) Increase awareness of options, 2) Prioritize options based on patient&#xD;
      lifestyle and values, 3) Build confidence in modality decision.&#xD;
&#xD;
      The investigators will develop individualized, digitalized educational content (which&#xD;
      includes videos, text and illustration) for patients with CKD that will increase awareness of&#xD;
      ESRD care options including in-home hemodialysis, peritoneal dialysis and choosing not to&#xD;
      have dialysis. Patients will enroll in a month-long program during which they have access to&#xD;
      the educational app, including lifestyle and modality educational content and online&#xD;
      messaging where they can access a nurse for 1 on 1 discussion, a patient mentor for 1 on 1&#xD;
      discussion, and a patient group for group mentorship exercises. The investigators will pilot&#xD;
      these materials in patients at high risk of progression to dialysis and evaluate the primary&#xD;
      outcomes of whether they were able to complete the program and make a modality choice.&#xD;
      Secondary outcomes will include assessments to determine the intervention's impact on patient&#xD;
      dialysis modality awareness and likelihood of choosing a home-dialysis modality. At the end&#xD;
      of the study, the investigators will provide an insights report to the study participants'&#xD;
      doctors and survey the doctors to ascertain their perspectives on the usefulness of the&#xD;
      educational program for their patients' care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>General Knowledge</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modality Knowledge</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>1 month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>End-Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Digital Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 month digital education program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Digital Education</intervention_name>
    <description>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.</description>
    <arm_group_label>Digital Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  eGFR &lt; 30ml/min/1.73m²&#xD;
&#xD;
          -  Regular attendance at the nephrology clinic; at least two visits within the last 18&#xD;
             months&#xD;
&#xD;
          -  Clinic notes indicate patient has had discussion with a nephrologist regarding needing&#xD;
             dialysis in the future&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Homelessness&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  No phone or no internet access on one of the following: smart phone, tablet, or&#xD;
             computer&#xD;
&#xD;
          -  No e-mail access&#xD;
&#xD;
          -  Age ≥ 90 years&#xD;
&#xD;
          -  Hospitalized more than twice during the last 6 months&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Blindness&#xD;
&#xD;
          -  Deafness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Dubin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco VA Medical Center: Clinical Research Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>14520619</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18440681</PMID>
  </reference>
  <reference>
    <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. doi: 10.1111/j.1523-1755.2005.00594.x.</citation>
    <PMID>16164654</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16310575</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02976220
org study id: 16-19626
nct id: NCT02976220
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
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
description: 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.
measure: General Knowledge
time frame: 1 month
description: 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.
measure: Modality Knowledge
time frame: 1 month
description: 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.
measure: Self-efficacy
time frame: 1 month
description: 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.
arm group label: Digital Education
arm group type: Experimental
description: 1 month digital education program
intervention type: Other
intervention name: Digital Education
description: 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.
arm group label: Digital Education
criteria: 
gender: All
minimum age: N/A
maximum age: 90 Years
healthy volunteers: No
last name: Ruth Dubin, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: 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
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.
PMID: 18440681
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. doi: 10.1111/j.1523-1755.2005.00594.x.
PMID: 16164654
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.
citation: 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
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided