Med-alert Bracelet in Chronic Kidney Disease
This study has been completed.
Sponsor:
University of Maryland
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
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| Tracking Information | |||||
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| First Received Date ICMJE | April 16, 2009 | ||||
| Last Updated Date | July 17, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
Questionnaire responses measured at 3 months after initiation of device use. [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00883389 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Med-alert Bracelet in Chronic Kidney Disease | ||||
| Official Title ICMJE | Safe Kidney Care Med-Alert Bracelet/Keytag | ||||
| 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 |
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| Detailed Description | No need for more extensive description |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with chronic kidney disease and impaired kidney function |
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| Condition ICMJE | Chronic Kidney Disease | ||||
| Intervention ICMJE | 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 |
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| Study Group/Cohort (s) | 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
Intervention: Device: Medical Alert Bracelet |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 26 | ||||
| Completion Date | May 2010 | ||||
| Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00883389 | ||||
| Other Study ID Numbers ICMJE | HP-00041163 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jeffrey C Fink, University of Maryland | ||||
| Study Sponsor ICMJE | University of Maryland | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Maryland | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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