NCT00883389

Brief Summary

This is a pilot observational study to evaluate subjects with chronic kidney disease acceptance of an alert device linked to an informational website intended to increase recognition of chronic kidney disease, and to guide patients and providers to the safe delivery of care required for this disease. Primary device was a bracelet with the alternative of a key fob with same information supplied when requested. Patients usage of the device was evaluated by survey with Likert scale as to whether the device is 0 = not useful, 1 = somewhat useful, 2 = extremely useful

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

April 16, 2009

Results QC Date

July 31, 2011

Last Update Submit

October 31, 2019

Conditions

Keywords

patient safetychronic kidney diseasemed-alert

Outcome Measures

Primary Outcomes (1)

  • Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.

    Qualitative questionnaire with primary assessment: "How useful do you think the Med-alert device will be for future healthcare". Response recorded based on a Likert scale with response of 0 = not useful, 1 = somewhat useful, 2 = extremely useful

    3 months

Study Arms (1)

Safe Kidney Care

Patients with Chronic Kidney Disease (eGFR \< 60 ml/min/1.732)and not expected to need dialysis within 6 months of enrollment

Device: Medical Alert Bracelet

Interventions

Medical Alert Bracelet alerting health care providers to consider the patient's chronic kidney disease condition when planning care. It also provides a link to a website about safe kidney care (safekidneycare.org)

Also known as: Safe Kidney Care
Safe Kidney Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease and impaired kidney function

You may qualify if:

  • Persons with chronic kidney disease defined as estimated glomerular filtration rate of \< 60 ml/min/1.73m2.

You may not qualify if:

  • Persons expected to be on dialysis within 6 months.
  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Emergency Medical Tags

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Dr. Jeffrey C. Fink, Associate Professor, Nephrology
Organization
University of Maryland, School of Medicine

Study Officials

  • Jeffrey C Fink, MD MS

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

May 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

November 4, 2019

Results First Posted

August 21, 2012

Record last verified: 2019-10