Care Coordination/Home Telehealth to Safeguard Care in CKD
CCHT in CKD
Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD
2 other identifiers
interventional
137
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedMarch 18, 2020
March 1, 2020
4.3 years
January 29, 2017
October 8, 2019
March 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Events
number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)
3 months, 6 months
Secondary Outcomes (2)
Change in Renal Function
6 months
Hospitalization
3 months, 6 months
Study Arms (2)
CCHT
ACTIVE COMPARATORVeterans Administration (VA) CCHT with an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
Usual care
PLACEBO COMPARATORInterventions
Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
Eligibility Criteria
You may qualify if:
- Veterans with Stage III-V CKD
- Diabetes
You may not qualify if:
- Expectation of dialysis or death within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey C. Fink, MD MS; Principal Investigator
- Organization
- University of Maryland Baltimore
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 29, 2017
First Posted
January 31, 2017
Study Start
May 1, 2014
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
March 18, 2020
Results First Posted
March 18, 2020
Record last verified: 2020-03