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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
No need for more extensive description
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Alert Bracelet | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease and impaired kidney function
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey C Fink, MD MS | University of Maryland, College Park | Principal Investigator |
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All recruited participants assigned to receive intervention (medical alert accessory)
Medical records of renal patients screened for eligibility upon arrival of their clinic appointment. Patients meeting study criteria approached at the end of their appointment regarding their interest in participating
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| ID | Title | Description |
|---|---|---|
| FG000 | Med-alert Bracelet Pilot Group | All participants assigned to the medical alert accessory group. There is no placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Med-alert Bracelet Pilot Group | All participants assigned to the medical alert accessory group. There is no placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | Likert scale | 3 months |
|
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3 months
Serious adverse events were collected if reported but not anticipated given the low risk of the medical alert device. Individuals at risk for such events were all those enrolled and were assessed in all this surveyed at 3 month time interval. None were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Med-alert Bracelet Pilot Group | All participants assigned to the medical alert accessory group. There is no placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey C. Fink, Associate Professor, Nephrology | University of Maryland, School of Medicine | 410-328-5720 | jfink@medicine.umaryland.edu |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004633 | Emergency Medical Tags |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 26 |
| 0 |
| 26 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |