Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease

NCT02097550 | Completed

• 2 other identifiers: IRB-283411K23DK097308-01A1
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Keywords

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Self Care; Consumer Participation; Patient Participation; Marketing; Consumer Health Information

Outcome Measures

Primary Outcomes (1)

• CKD metabolic control score

  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.

  12 months

Secondary Outcomes (11)

• New indicated med prescriptions

  12 months

• Adherence proxy measures

  12 months

• Patient and provider satisfaction

  12 months

• Urine albumin

  6 months

• Systolic blood pressure

  6 months

Study Arms (2)

eHealth Intervention

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

These patients will receive the standard of care from their physician.

Interventions

eHealth Intervention OTHER

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.

eHealth Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Patient Participation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Veronica Yank, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: March 27, 2014
• Study Start: May 1, 2016
• Primary Completion: November 29, 2018
• Study Completion: December 3, 2018
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)