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Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease (CKD eHealth)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Veronica Yank, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02097550
First received: December 11, 2013
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
This project seeks to improve the health of patients with chronic kidney disease (CKD) by developing and testing an electronic health intervention (that will combine secure e--mail, smartphone text message, and online video materials) to promote patient use of effective medications. The information we collect on the electronic health intervention will guide future research, including a larger trial and other studies among related patient groups (e.g., racial minorities) and diseases (e.g., type 2 diabetes mellitus). The project has the potential to improve health outcomes for the millions of patients with CKD who are not yet receiving effective medications.

Condition Intervention Phase
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Other: eHealth Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • CKD metabolic control score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A "CKD score" will be assigned to each patient at baseline and 12-month follow-up, which will be the primary outcome of the trial. The clinical targets that comprise the CKD score consist of laboratory or clinical measurements that are routinely performed in primary care settings and, as such, are readily available in the EHR. While apparent face validity and convenience provide a good rationale for introducing the CKD score, we also recognize the need to validate the score, which we will do in stages in both Aims 1 and 2 of the study.


Secondary Outcome Measures:
  • New indicated med prescriptions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    New prescriptions for indicated medications.

  • Adherence proxy measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Refills for prescriptions to prescribed medications.

  • Patient and provider satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient and provider satisfaction will be derived from online questionnaires.

  • Urine albumin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Urine albumin

  • Systolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Systolic blood pressure

  • Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hemoglobin A1c

  • LDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    LDL cholesterol

  • CKD progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CKD progression measured by eGFR

  • Diastolic blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Diastolic blood pressure

  • HDL cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HDL cholesterol

  • Total cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total cholesterol


Estimated Enrollment: 100
Study Start Date: May 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eHealth Intervention
Patients randomized to this arm will receive eHealth materials every 2-4 weeks over the 12-month intervention. However, the exact nature of timing, dose, and delivery channel will be informed by the formative research.
Other: eHealth Intervention
Patients randomized to this arm will receive eHealth materials every 2-4 weeks over the 12-month intervention. However, the exact nature of timing, dose, and delivery channel will be informed by the formative research.
No Intervention: Standard of care
These patients will receive the standard of care from their physician.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 3a (eGFR 45-59) plus poorly controlled risk factors for CKD progression and/or cardiovascular disease morbidity/mortality). Our intervention is appropriate for patients with stage 3a CKD who are not yet optimized for kidney protection (in the setting of proteinuria) with ACE-inhibitors/ARBS, hypertension, diabetes and cardiovascular disease treatment. Our intervention messages promote medication classes for the optimization of these conditions and thus are appropriate for patients with stage 3a CKD who are not yet controlled for these conditions
  • Stage 3b chronic kidney disease (defined as eGFR 30-44): The rationale for including patients with stage 3b CKD (defined by eGFR 30-44) but not stage 3a (eGFR 45-59) is to reduce the possibility of misclassification of those with higher eGFRs (who have little or no underlying kidney dysfunction) and to respond to evidence that patients with stage 3b CKD have much higher rates of progression to kidney failure than those with stage 3a. We chose the following inclusion criteria to optimize the balance between generalizability, participant safety, treatment adherence, and retention.
  • Having a primary care provider (PCP) at UCSF, defined as an identified individual provider or provider group from whom the participant receives ongoing medical care, if needed;
  • Not pregnant at study assessment.
  • The ability to use a computer or smartphone
  • The ability to understand English

Exclusion Criteria:

  • Severe hypertriglyceridemia (TG>500 mg/dL)
  • Hyperkalemia (K>5.0 mEq/L)
  • Serious illness likely to preclude study completion
  • Pregnancy
  • Intolerance/allergy to all indicated CKD medications
  • Medication management for CKD (i.e., with all of the medications/medication classes targeted for promotion by the eHealth intervention) has already been optimized
  • Has never used MyChart: because MyChart use indicates a minimum level of existing familiarity with and use of eHealth materials
  • Having no access to a computer or smartphone
  • Plans to change primary care site.
  • Family/household member of another study participant or of a study staff member;
  • Already enrolled or planning to enroll in a research study that would limit full participation in this trial or confound interpretation of its results;
  • Investigator discretion for clinical safety or protocol adherence reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097550

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Veronica Yank, MD University of California, San Francisco
  More Information

Responsible Party: Veronica Yank, Principle Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02097550     History of Changes
Other Study ID Numbers: IRB-28341  1K23DK097308-01A1 
Study First Received: December 11, 2013
Last Updated: September 16, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Self Care
Consumer Participation
Patient Participation
Marketing
Consumer Health Information

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on December 02, 2016