Ignite Creation Date:
2024-05-06 @ 9:38 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03038126
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2017-01-29
Brief Title:
Care CoordinationHome Telehealth to Safeguard Care in CKD
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Care CoordinationTelehealth to Address Patient Safety and Poor Outcomes in CKD
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCHT in CKD
Brief Summary:
Home telehealth monitoring of veterans with chronic kidney disease with a disease management protocol and safety-specific decision support will increase the detection of adverse safety events and in turn reduce the need for urgent health resource utilization and associated poor outcomes
Detailed Description:
Pre-dialysis chronic kidney disease CKD is associated with a high risk of harm related to medical care adverse safety events These events may occur outside the purview of the medical system and hence are under-recognized Health information technology IT can enhance the detection of such events and coordinated care can prevent their adverse consequences Study design 6-month randomized trial of coordinated carehome telehealth CCHT vs usual care in CKD patients Intervention Veterans Administration VA CCHT with a guideline-based CKD DMP augmented laboratory monitoring and decision support from the VA Renal Inter-disciplinary Safety clinic RISC Study population Veterans with Stage III-V CKD no expected dialysis within 6 months age 60 years old and diabetes n 65 per arm Study Site Baltimore VA Medical Center BVAMC VA Geriatrics Research Education and Clinical Center GRECC and RISC Specific Aim 1 Compare detection of adverse safety events in CKD patients assigned to CCHT vs usual care Specific Aim 2 Compare the frequency of urgent health service use and participant satisfaction with CCHT vs usual care group Study Measurements Vital sign and clinical measurements daily BP weight and finger stick glucose laboratory values and patient- reported safety events obtained per CCHT protocol vs patient-reported safety events laboratory values and assessment at a mid-study safety clinic visit in usual care protocol Emergency department ED visits hospitalization renal progression incidence of ESRD and death will be measured in both groups along with patient satisfaction Outcomes Aim 1 Counts of a diverse set of adverse safety events including hypoglycemia hypotension volume loss by weight change hyperkalemia acute kidney injury AKI and patient-reported safety incidents Aim 2 ED visits hospitalization and other adverse outcomes including renal function loss ESRD and death Analytic plans Adjusted rates of events tracked in Aim 1 and 2 and expressed as counts per month will be compared in CCHT vs usual care group with multivariate models as indicated Expected findings CCHT will increase the detection of adverse safety events but reduce urgent health resource utilization and adverse outcomes Public Health Relevance Home telemonitoring of CKD patients in conjunction with coordinated care and decision support can increase the detection of adverse safety events that occur outside the traditional health care system and offer new opportunities to reduce their associated poor outcomes on a platform that allows ready dissemination across a national health network
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34DK102177 | NIH | None | httpsreporternihgovquickSearchR34DK102177 |