An interventional study of CCHT and Usual care in Safety Issues and Chronic Kidney Disease, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Health services research
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 137 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Other: CCHT
Other: Usual care
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).
Standard clinical care
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
Change in Renal Function
Change in GFR from baseline to 6 months
Time frame: 6 months
Hospitalization
Frequency of unanticipated hospitalization events over duration of study
Time frame: 3 months, 6 months
| Milestone | CCHT | Usual Care |
|---|---|---|
| Started | 63 | 55 |
| Completed | 54 | 51 |
| Not completed | 9 | 4 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Withdrawal by subject | 5 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Long term hospitalization | 2 | 0 |
| Withdrew: Too ill to participate | 1 | 2 |
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.)
| safety events | CCHT | Usual Care |
|---|---|---|
| Self-Reported Safety Events (3 months) | 70 | 54 |
| Self-Reported Safety Events (6 months) | 61 | 58 |
| In-Center Safety Events (3 months) | 30 | 30 |
| In-Center Safety Events (6 months) | 26 | 28 |
Change in GFR from baseline to 6 months
| ml/min/1.73m2 | CCHT | Usual Care |
|---|---|---|
| Change in Renal Function | -0.36 ± 6.44 | -3.19 ± 9.44 |
Frequency of unanticipated hospitalization events over duration of study
| hospitalizaztions per month | CCHT | Usual Care |
|---|---|---|
| Reported at 3 month visit | 0.11 (0.07 to 0.17) | 0.14 (0.08 to 0.27) |
| Reported at 6 month visit | 0.11 (0.07 to 0.18) | 0.15 (0.10 to 0.23) |
Collected over Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CCHT | 1/63 (1.6%) | 0/63 (0%) | 49/63 (77.8%) |
| Usual Care | 1/55 (1.8%) | 0/55 (0%) | 51/55 (92.7%) |
| Event | CCHT | Usual Care |
|---|---|---|
| In-Center OrthostasisCardiac disorders | 30/63 | 36/55 |
| In-Center HypotensionCardiac disorders | 11/63 | 10/55 |
| Patient-Reported New or Worseneing Ankle SwellingCardiac disorders | 10/63 | 10/55 |
| Patient-Reported Nausea, Vomiting, and/or DiarrheaGastrointestinal disorders | 9/63 | 8/55 |
| Patient-Reported Muscle Weakness or CrampsGeneral disorders | 9/63 | 8/55 |
| In-Center HypoglycemiaEndocrine disorders | 7/63 | 7/55 |
| Patient-Reported DizzinessGeneral disorders | 5/63 | 7/55 |
| Patient-Reported BleedingBlood and lymphatic system disorders | 2/63 | 5/55 |
| Patient-Reported HyperkalemiaRenal and urinary disorders | 5/63 | 4/55 |
| Patient-Reported FallsGeneral disorders | 3/63 | 4/55 |
| Age, Continuous(year) | CCHT | Usual Care | Total |
|---|---|---|---|
| Mean | 70.9 ± 5.4 | 70.7 ± 6.2 | 70.8 ± 5.8 |
| Sex: Female, Male(Participants) | CCHT | Usual Care | Total |
|---|---|---|---|
| Female | 61 | 53 | 114 |
| Male | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | CCHT | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 37 | 36 | 73 |
| White | 24 | 17 | 41 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | CCHT | Usual Care | Total |
|---|---|---|---|
| United States | 63 | 55 | 118 |
| eGFR(ml/min/1.73m2) | CCHT | Usual Care | Total |
|---|---|---|---|
| Mean | 42.5 ± 12.7 | 42.4 ± 13.9 | 42.5 ± 13.2 |
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University of Maryland, Baltimore