Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
Study NCT ID:
NCT02097550
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2013-12-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Primary Care eHealth Intervention for Improved Outcomes in Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CKD eHealth
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.
Detailed Description:
Specific Aims:
Chronic Kidney Disease (CKD) affects over 20 million American adults. Effective medications for reducing progression remain vastly under-utilized due to well-known behavioral barriers for patients and clinicians, including the affective barriers of denial, inertia, and uncertainty. The health consequences of this poor level of medication adoption warrant development of new strategies to facilitate their use.
Moderate CKD as a Critical Juncture for Intervention: Rates of CKD are likely only to escalate as contributing conditions (e.g., type 2 diabetes, obesity) increase. With progression, patients experience costly but preventable renal and cardiovascular disease adverse outcomes (e.g., dialysis, myocardial infarction). CKD also imposes a disproportionately heavy burden on racial/ethnic minorities and those of lower socioeconomic status. There are an estimated 8 million U.S. adults with stage 3 or "moderate" CKD (defined by an estimated glomerular filtration rate (eGFR) of 30-59 mL/min/1.73m2) offering a sizeable target population for intervention. Patients with stage 3 CKD are often diagnosed at this stage of disease through routine laboratory tests performed by their primary care providers and at a time when disease progression can still be minimized. Evidence shows that use of four categories of medications (for renal protection, hypertension, diabetes, and hyperlipidemia) can slow or even halt CKD disease progression.
Underutilization of Effective Medications for CKD Exposes a Quality Gap: These effective drugs remain vastly under-utilized despite their promotion through drug formularies, practice guidelines, and clinician and patient educational campaigns, including the landmark 2002 Kidney Disease Outcomes Quality Initiative and related undertakings. National ambulatory data indicate that even among patients with CKD who are diagnosed with cardiovascular disease (CVD), only 57% are on an angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB), only 35% have achieved the target blood pressure control, and only 52% are taking a lipid-lowering agent, despite their clear benefits in high-risk populations. Those without a CVD diagnosis have comparable or even worse rates for these target measures. After a system-wide quality improvement initiative, Southern California Kaiser patients identified as having CKD still had notable quality gaps in care: though improved, 16% were missing an ACE-I/ARB, 56% had poorly controlled blood pressure, 40% had LDL over the target, and 50% of those with comorbid type 2 diabetes (diabetes) had hemoglobin A1c levels of 7% or greater.
Aim 1: Formative research-Develop the eHealth intervention Challenge: There is good evidence on how to target conscious processing for health behavior change but less on affective processing. Approach: Using a theory-based approach, we will identify the promising content, minimum dose, and delivery for an eHealth intervention to promote appropriate medication adoption. We will use observational, systematic review, and qualitative methodologies for this formative research with a special emphasis on targeting affective processing (in addition to conscious processing). Impact: We will develop an e-Health intervention that is anticipated to have an effective content, dose, and delivery.
Aim 2: Evaluative research-Pilot test the eHealth intervention in a small RCT Challenge: The eHealth intervention must be piloted and refined prior to a definitive investigation of its efficacy. Approach: We will test the eHealth intervention for feasibility in a 2-arm pilot RCT (intervention vs. usual care controls) among patients with stage 3b CKD managed in primary care and their clinicians, while also collecting data critical to designing a future efficacy trial. Randomization: patients (50/arm) will be clustered by clinician (20/arm) with targeted inclusion of 1-3/clinician. Primary outcome: 4-point "CKD score" assessing control of risk factors for CKD progression (proteinuria, blood pressure, plasma glucose, cholesterol level/calculated CVD risk). H1: the intervention group will achieve a better mean CKD score than the usual care group. Secondary outcomes: new prescriptions for the promoted medications, CKD progression, and feasibility and process data. Impact: A new intervention specifically targeted at medication adoption that is ready for evaluation in a larger efficacy RCT.
Chronic Kidney Disease (CKD) affects over 20 million American adults. Effective medications for reducing progression remain vastly under-utilized due to well-known behavioral barriers for patients and clinicians, including the affective barriers of denial, inertia, and uncertainty. The health consequences of this poor level of medication adoption warrant development of new strategies to facilitate their use.
Moderate CKD as a Critical Juncture for Intervention: Rates of CKD are likely only to escalate as contributing conditions (e.g., type 2 diabetes, obesity) increase. With progression, patients experience costly but preventable renal and cardiovascular disease adverse outcomes (e.g., dialysis, myocardial infarction). CKD also imposes a disproportionately heavy burden on racial/ethnic minorities and those of lower socioeconomic status. There are an estimated 8 million U.S. adults with stage 3 or "moderate" CKD (defined by an estimated glomerular filtration rate (eGFR) of 30-59 mL/min/1.73m2) offering a sizeable target population for intervention. Patients with stage 3 CKD are often diagnosed at this stage of disease through routine laboratory tests performed by their primary care providers and at a time when disease progression can still be minimized. Evidence shows that use of four categories of medications (for renal protection, hypertension, diabetes, and hyperlipidemia) can slow or even halt CKD disease progression.
Underutilization of Effective Medications for CKD Exposes a Quality Gap: These effective drugs remain vastly under-utilized despite their promotion through drug formularies, practice guidelines, and clinician and patient educational campaigns, including the landmark 2002 Kidney Disease Outcomes Quality Initiative and related undertakings. National ambulatory data indicate that even among patients with CKD who are diagnosed with cardiovascular disease (CVD), only 57% are on an angiotensin converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB), only 35% have achieved the target blood pressure control, and only 52% are taking a lipid-lowering agent, despite their clear benefits in high-risk populations. Those without a CVD diagnosis have comparable or even worse rates for these target measures. After a system-wide quality improvement initiative, Southern California Kaiser patients identified as having CKD still had notable quality gaps in care: though improved, 16% were missing an ACE-I/ARB, 56% had poorly controlled blood pressure, 40% had LDL over the target, and 50% of those with comorbid type 2 diabetes (diabetes) had hemoglobin A1c levels of 7% or greater.
Aim 1: Formative research-Develop the eHealth intervention Challenge: There is good evidence on how to target conscious processing for health behavior change but less on affective processing. Approach: Using a theory-based approach, we will identify the promising content, minimum dose, and delivery for an eHealth intervention to promote appropriate medication adoption. We will use observational, systematic review, and qualitative methodologies for this formative research with a special emphasis on targeting affective processing (in addition to conscious processing). Impact: We will develop an e-Health intervention that is anticipated to have an effective content, dose, and delivery.
Aim 2: Evaluative research-Pilot test the eHealth intervention in a small RCT Challenge: The eHealth intervention must be piloted and refined prior to a definitive investigation of its efficacy. Approach: We will test the eHealth intervention for feasibility in a 2-arm pilot RCT (intervention vs. usual care controls) among patients with stage 3b CKD managed in primary care and their clinicians, while also collecting data critical to designing a future efficacy trial. Randomization: patients (50/arm) will be clustered by clinician (20/arm) with targeted inclusion of 1-3/clinician. Primary outcome: 4-point "CKD score" assessing control of risk factors for CKD progression (proteinuria, blood pressure, plasma glucose, cholesterol level/calculated CVD risk). H1: the intervention group will achieve a better mean CKD score than the usual care group. Secondary outcomes: new prescriptions for the promoted medications, CKD progression, and feasibility and process data. Impact: A new intervention specifically targeted at medication adoption that is ready for evaluation in a larger efficacy RCT.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23DK097308-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |