Trial Outcomes & Findings for Empowering Patients On Choices for Renal Replacement Therapy (Aim 1) (NCT NCT01952600)
NCT ID: NCT01952600
Last Updated: 2016-09-20
Results Overview
Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.
Recruitment status
COMPLETED
Target enrollment
215 participants
Primary outcome timeframe
Baseline
Results posted on
2016-09-20
Participant Flow
Participant milestones
| Measure |
Chronic Kidney Disease (CKD)
Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
|
Hemodialysis (HD)
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
|
Peritoneal Dialysis (PD)
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
80
|
90
|
45
|
|
Overall Study
COMPLETED
|
65
|
77
|
38
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empowering Patients On Choices for Renal Replacement Therapy (Aim 1)
Baseline characteristics by cohort
| Measure |
Chronic Kidney Disease (CKD)
n=65 Participants
Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
|
Hemodialysis (HD)
n=77 Participants
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
|
Peritoneal Dialysis (PD)
n=38 Participants
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
117 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Continuous
|
63.40 years
STANDARD_DEVIATION 56.14 • n=5 Participants
|
56.14 years
STANDARD_DEVIATION 16.65 • n=7 Participants
|
50.37 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
57.54 years
STANDARD_DEVIATION 16.76 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
77 participants
n=7 Participants
|
38 participants
n=5 Participants
|
180 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineDifferences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.
Outcome measures
| Measure |
Chronic Kidney Disease (CKD)
n=65 Participants
Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
|
Hemodialysis (HD)
n=77 Participants
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
|
Peritoneal Dialysis (PD)
n=38 Participants
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
|
|---|---|---|---|
|
Factors That Are Most Important to Patients
Keeping as much independence as possible
|
98 % of patients
|
93 % of patients
|
97 % of patients
|
|
Factors That Are Most Important to Patients
Quality and quantity of life
|
100 % of patients
|
89 % of patients
|
92 % of patients
|
|
Factors That Are Most Important to Patients
Flexibility in daily schedule
|
90 % of patients
|
0 % of patients
|
94 % of patients
|
|
Factors That Are Most Important to Patients
Important to do dialysis at home
|
67 % of patients
|
0 % of patients
|
89 % of patients
|
|
Factors That Are Most Important to Patients
Planned schedule at dialysis center
|
68 % of patients
|
76 % of patients
|
0 % of patients
|
|
Factors That Are Most Important to Patients
Safer to do dialysis at a medical place
|
55 % of patients
|
74 % of patients
|
0 % of patients
|
|
Factors That Are Most Important to Patients
Ability to go to school and work
|
43 % of patients
|
0 % of patients
|
71 % of patients
|
|
Factors That Are Most Important to Patients
Concern about the way you look
|
43 % of patients
|
32 % of patients
|
42 % of patients
|
|
Factors That Are Most Important to Patients
Spending time with patients at dialysis center
|
21 % of patients
|
52 % of patients
|
0 % of patients
|
|
Factors That Are Most Important to Patients
Worry about how dialysis will affect others
|
43 % of patients
|
33 % of patients
|
29 % of patients
|
Adverse Events
Chronic Kidney Disease (CKD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemodialysis (HD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peritoneal Dialysis (PD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Francesca Tentori
Arbor Research Collaborative for Health
Phone: 7346654108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place