Trial Outcomes & Findings for Care Coordination/Home Telehealth to Safeguard Care in CKD (NCT NCT03038126)
NCT ID: NCT03038126
Last Updated: 2020-03-18
Results Overview
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.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
137 participants
Primary outcome timeframe
3 months, 6 months
Results posted on
2020-03-18
Participant Flow
Participant milestones
| Measure |
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).
|
Usual Care
Usual care: Standard clinical care
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
55
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
| Measure |
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).
|
Usual Care
Usual care: Standard clinical care
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Long Term Hospitalization
|
2
|
0
|
|
Overall Study
Too Ill to Participate
|
1
|
2
|
Baseline Characteristics
Care Coordination/Home Telehealth to Safeguard Care in CKD
Baseline characteristics by cohort
| Measure |
CCHT
n=63 Participants
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).
|
Usual Care
n=55 Participants
Usual care: Standard clinical care
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.9 year
STANDARD_DEVIATION 5.4 • n=5 Participants
|
70.7 year
STANDARD_DEVIATION 6.2 • n=7 Participants
|
70.8 year
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
55 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
eGFR
|
42.5 ml/min/1.73m2
STANDARD_DEVIATION 12.7 • n=5 Participants
|
42.4 ml/min/1.73m2
STANDARD_DEVIATION 13.9 • n=7 Participants
|
42.5 ml/min/1.73m2
STANDARD_DEVIATION 13.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
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.)
Outcome measures
| Measure |
CCHT
n=63 Participants
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).
|
Usual Care
n=55 Participants
Usual care: Standard clinical care
|
|---|---|---|
|
Safety Events
Self-Reported Safety Events (3 months)
|
70 safety events
|
54 safety events
|
|
Safety Events
Self-Reported Safety Events (6 months)
|
61 safety events
|
58 safety events
|
|
Safety Events
In-Center Safety Events (3 months)
|
30 safety events
|
30 safety events
|
|
Safety Events
In-Center Safety Events (6 months)
|
26 safety events
|
28 safety events
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Change in GFR from baseline to 6 months
Outcome measures
| Measure |
CCHT
n=61 Participants
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).
|
Usual Care
n=53 Participants
Usual care: Standard clinical care
|
|---|---|---|
|
Change in Renal Function
|
-0.36 ml/min/1.73m2
Standard Deviation 6.44
|
-3.19 ml/min/1.73m2
Standard Deviation 9.44
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
Frequency of unanticipated hospitalization events over duration of study
Outcome measures
| Measure |
CCHT
n=63 Participants
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).
|
Usual Care
n=55 Participants
Usual care: Standard clinical care
|
|---|---|---|
|
Hospitalization
Reported at 3 month visit
|
0.11 hospitalizaztions per month
Interval 0.07 to 0.17
|
0.14 hospitalizaztions per month
Interval 0.08 to 0.27
|
|
Hospitalization
Reported at 6 month visit
|
0.11 hospitalizaztions per month
Interval 0.07 to 0.18
|
0.15 hospitalizaztions per month
Interval 0.1 to 0.23
|
Adverse Events
CCHT
Serious events: 0 serious events
Other events: 49 other events
Deaths: 1 deaths
Usual Care
Serious events: 0 serious events
Other events: 51 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CCHT
n=63 participants at risk
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).
|
Usual Care
n=55 participants at risk
Usual care: Standard clinical care
|
|---|---|---|
|
Endocrine disorders
In-Center Hypoglycemia
|
11.1%
7/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
12.7%
7/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Endocrine disorders
In-Center Hyperglycemia
|
3.2%
2/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
5.5%
3/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Cardiac disorders
In-Center Hypotension
|
17.5%
11/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
18.2%
10/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Cardiac disorders
In-Center Orthostasis
|
47.6%
30/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
65.5%
36/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Renal and urinary disorders
Patient-Reported Hyperkalemia
|
7.9%
5/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
7.3%
4/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
General disorders
Patient-Reported Dizziness
|
7.9%
5/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
12.7%
7/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
General disorders
Patient-Reported Falls
|
4.8%
3/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
7.3%
4/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Blood and lymphatic system disorders
Patient-Reported Bleeding
|
3.2%
2/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
9.1%
5/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Gastrointestinal disorders
Patient-Reported Nausea, Vomiting, and/or Diarrhea
|
14.3%
9/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
14.5%
8/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
Cardiac disorders
Patient-Reported New or Worseneing Ankle Swelling
|
15.9%
10/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
18.2%
10/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
|
General disorders
Patient-Reported Muscle Weakness or Cramps
|
14.3%
9/63 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
14.5%
8/55 • Adverse event data was collected over the duration of study participation up to 6 months per participant or censor if earlier
|
Additional Information
Jeffrey C. Fink, MD MS; Principal Investigator
University of Maryland Baltimore
Phone: 410-328-4822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place