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Med-alert Bracelet in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey C Fink, University of Maryland
ClinicalTrials.gov Identifier:
NCT00883389
First received: April 16, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Chronic Kidney Disease
 Device: Medical Alert Bracelet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safe Kidney Care Med-Alert Bracelet/Keytag

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Qualitative Survey Assessmentof Perceived Usefulness of the Med-alert Device. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Enrollment: 26
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Safe Kidney Care

Detailed Description:

No need for more extensive description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic kidney disease and impaired kidney function

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883389

Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Jeffrey C Fink, MD MS University of Maryland
  More Information

No publications provided

Responsible Party: Jeffrey C Fink, Professor, Nephrology (primary); Epidemiology (secondary), University of Maryland
ClinicalTrials.gov Identifier: NCT00883389     History of Changes
Other Study ID Numbers: HP-00041163
Study First Received: April 16, 2009
Results First Received: July 31, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
patient safety
chronic kidney disease
med-alert

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013