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Care Coordination/Home Telehealth to Safeguard Care in CKD

Care Coordination/Telehealth to Address Patient Safety and Poor Outcomes in CKD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03038126
Acronym
CCHT in CKD
Enrollment
137
Registered
2017-01-31
Start date
2014-05-31
Completion date
2018-08-31
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Safety Issues

Keywords

chronic kidney disease, patient safety, home telehealth

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 care/home 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.

Interventions

OTHERCCHT

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).

OTHERUsual care

Standard clinical care

Sponsors

Baltimore VA Medical Center
CollaboratorFED
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Veterans with Stage III-V CKD * Diabetes

Exclusion criteria

* Expectation of dialysis or death within 6 months

Design outcomes

Primary

MeasureTime frameDescription
Safety Events3 months, 6 monthsnumber 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.)

Secondary

MeasureTime frameDescription
Change in Renal Function6 monthsChange in GFR from baseline to 6 months
Hospitalization3 months, 6 monthsFrequency of unanticipated hospitalization events over duration of study

Countries

United States

Participant flow

Participants by arm

ArmCount
CCHT
Veterans 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). CCHT: 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).
63
Usual Care
Usual care: Standard clinical care
55
Total118

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath11
Overall StudyLong Term Hospitalization20
Overall StudyLost to Follow-up01
Overall StudyToo Ill to Participate12
Overall StudyWithdrawal by Subject50

Baseline characteristics

CharacteristicCCHTUsual CareTotal
Age, Continuous70.9 year
STANDARD_DEVIATION 5.4
70.7 year
STANDARD_DEVIATION 6.2
70.8 year
STANDARD_DEVIATION 5.8
eGFR42.5 ml/min/1.73m2
STANDARD_DEVIATION 12.7
42.4 ml/min/1.73m2
STANDARD_DEVIATION 13.9
42.5 ml/min/1.73m2
STANDARD_DEVIATION 13.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
37 Participants36 Participants73 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
24 Participants17 Participants41 Participants
Region of Enrollment
United States
63 participants55 participants118 participants
Sex: Female, Male
Female
61 Participants53 Participants114 Participants
Sex: Female, Male
Male
2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 631 / 55
other
Total, other adverse events
49 / 6351 / 55
serious
Total, serious adverse events
0 / 630 / 55

Outcome results

Primary

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.)

Time frame: 3 months, 6 months

Population: number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.

ArmMeasureGroupValue (NUMBER)
CCHTSafety EventsSelf-Reported Safety Events (3 months)70 safety events
CCHTSafety EventsSelf-Reported Safety Events (6 months)61 safety events
CCHTSafety EventsIn-Center Safety Events (3 months)30 safety events
CCHTSafety EventsIn-Center Safety Events (6 months)26 safety events
Usual CareSafety EventsIn-Center Safety Events (6 months)28 safety events
Usual CareSafety EventsSelf-Reported Safety Events (3 months)54 safety events
Usual CareSafety EventsIn-Center Safety Events (3 months)30 safety events
Usual CareSafety EventsSelf-Reported Safety Events (6 months)58 safety events
Secondary

Change in Renal Function

Change in GFR from baseline to 6 months

Time frame: 6 months

Population: number analyzed differs from total population due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.

ArmMeasureValue (MEAN)Dispersion
CCHTChange in Renal Function-0.36 ml/min/1.73m2Standard Deviation 6.44
Usual CareChange in Renal Function-3.19 ml/min/1.73m2Standard Deviation 9.44
Secondary

Hospitalization

Frequency of unanticipated hospitalization events over duration of study

Time frame: 3 months, 6 months

Population: number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.

ArmMeasureGroupValue (MEAN)
CCHTHospitalizationReported at 3 month visit0.11 hospitalizaztions per month
CCHTHospitalizationReported at 6 month visit0.11 hospitalizaztions per month
Usual CareHospitalizationReported at 3 month visit0.14 hospitalizaztions per month
Usual CareHospitalizationReported at 6 month visit0.15 hospitalizaztions per month

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026