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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02097550
First received: December 11, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

The investigator hypothesizes that the eHealth intervention will improve outcomes (eg, adherence to recommended effective and low cost medications for CKD) over current practice by targeting both the conscious and unconscious/affective processing systems of human cognition using theory-based, multicomponent, multichannel materials directed at both patients and clinicians.


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

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 Stanford University:

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 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 years or older
  • eGFR 30-49
  • Not pregnant at study assessment.
  • The ability to use a computer or smartphone
  • The ability to understand English

Exclusion Criteria:

  • If patient's CKD care is being delivered by a nephrologist (not the primary care provider)
  • 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
  • Plans to change primary care site.
  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

Contacts
Contact: Veronica Yank, MD 206-459-5316 vyank@stanford.edu
Contact: Isabella M Chu, MPH 650-207-2208 isabella.chu@stanford.edu

Locations
United States, California
Palo Alto Medical Foundation Research Institute Not yet recruiting
Palo Alto, California, United States, 94301
Contact: Jun Ma, MD    650-853-4809    maj@pamfri.org   
Stanford University Medical Center Not yet recruiting
Stanford, California, United States, 94305
Contact: Veronica Yank, MD    206-459-5316    vyank@stanford.edu   
Contact: Isabella Chu, MPH    650-723-2513    isabella.chu@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Veronica Yank, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02097550     History of Changes
Other Study ID Numbers: IRB-28341, 1K23DK097308-01A1
Study First Received: December 11, 2013
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Self Care
Consumer Participation
Patient Participation
Marketing
Consumer Health Information

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

ClinicalTrials.gov processed this record on August 28, 2014