Med-alert Bracelet in Chronic Kidney Disease

October 31, 2019 updated by: Jeffrey Fink, University of Maryland, Baltimore

Safe Kidney Care Med-Alert Bracelet/Keytag

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No need for more extensive description

Study Type

Observational

Enrollment (Actual)

26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease and impaired kidney function

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Other Names:
  • Safe Kidney Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device.
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Jeffrey C Fink, MD MS, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (ESTIMATE)

April 17, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00041163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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