Clinical trial NCT01530958: Kidney Awareness Registry and Education
Official title: The Kidney Awareness Registry and Education Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease (CKD)
Keywords: CKD
Automated Telephone Self Management
Registry
CKD awareness
Self efficacy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-02-10
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.


Eligibility criteria: Inclusion Criteria:

* Patients with CKD (defined as estimated Glomerular Filtration Rate \< 60ml/min/1.73m2 or proteinuria consistently over 3 months) who speak English, Spanish or Cantonese and have a primary care provider

Exclusion Criteria:

* Kidney transplant recipients; pregnant women; individuals with an eGFR \<15 ml/min/1.73 m2; prevalent dementia; impaired cognition or severe mental illness; expected life expectancy \<6 months; no phone access; self-reported hearing impairment; severe visual impairment preventing use of a touch-tone telephone keypad; and non-study language

Primary outcomes:
measure: Change in blood pressure measurement at baseline and at one year follow-up
timeFrame: Baseline and one year follow-up
Secondary outcomes:
measure: Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up
timeFrame: Baseline and one year follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Department of Public Health
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Neil Powe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Machen L, Handley MA, Powe N, Tuot D. Engagement With a Health Information Technology-Augmented Self-Management Support Program in a Population With Limited English Proficiency: Observational Study. JMIR Mhealth Uhealth. 2021 May 11;9(5):e24520. doi: 10.2196/24520.
citation: Tuot DS, Rubinsky AD, Velasquez A, McCulloch CE, Schillinger D, Handley MA, Hsu CY, Powe NR. Interventions to Improve Blood Pressure Control Among Socioeconomically Disadvantaged Patients With CKD: Kidney Awareness Registry and Education Pilot Randomized Controlled Trial. Kidney Med. 2019 Aug 30;1(5):242-252. doi: 10.1016/j.xkme.2019.07.004. eCollection 2019 Sep-Oct.
citation: Tuot DS, Velasquez A, McCulloch CE, Banerjee T, Zhu Y, Hsu CY, Handley M, Schillinger D, Powe NR. The Kidney Awareness Registry and Education (KARE) study: protocol of a randomized controlled trial to enhance provider and patient engagement with chronic kidney disease. BMC Nephrol. 2015 Oct 22;16:166. doi: 10.1186/s12882-015-0168-4.