Trial Outcomes & Findings for Empowering Patients on Choices for Renal Replacement Therapy (Aim 2) (NCT NCT02440659)
NCT ID: NCT02440659
Last Updated: 2017-05-10
Results Overview
% of patients very much or extremely affected by dialysis
Recruitment status
COMPLETED
Target enrollment
2946 participants
Primary outcome timeframe
Baseline
Results posted on
2017-05-10
Participant Flow
Participant milestones
| Measure |
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
|
1997
|
949
|
|
Overall Study
COMPLETED
|
1346
|
614
|
|
Overall Study
NOT COMPLETED
|
651
|
335
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
Baseline characteristics by cohort
| Measure |
Hemodialysis (HD)
n=1346 Participants
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
|
Peritoneal Dialysis (PD)
n=614 Participants
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
|
Total
n=1960 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
686 participants
n=99 Participants
|
384 participants
n=107 Participants
|
1070 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
649 participants
n=99 Participants
|
229 participants
n=107 Participants
|
878 participants
n=206 Participants
|
|
Age, Continuous
|
63.04 years
STANDARD_DEVIATION 14.44 • n=99 Participants
|
59.90 years
STANDARD_DEVIATION 14.92 • n=107 Participants
|
62.06 years
STANDARD_DEVIATION 14.66 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
571 participants
n=99 Participants
|
282 participants
n=107 Participants
|
853 participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
766 participants
n=99 Participants
|
331 participants
n=107 Participants
|
1097 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1346 participants
n=99 Participants
|
614 participants
n=107 Participants
|
1960 participants
n=206 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline% of patients very much or extremely affected by dialysis
Outcome measures
| Measure |
Hemodialysis (HD)
n=1346 Participants
Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
|
Peritoneal Dialysis (PD)
n=614 Participants
Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
|
|---|---|---|
|
Patient's Quality of Life
Drinking as much water as I want
|
46 % of patients
|
24 % of patients
|
|
Patient's Quality of Life
Eating what I like
|
38 % of patients
|
24 % of patients
|
|
Patient's Quality of Life
Relying on myself
|
34 % of patients
|
38 % of patients
|
|
Patient's Quality of Life
Doing what I want in my free time
|
35 % of patients
|
27 % of patients
|
|
Patient's Quality of Life
Spending time with people I care about
|
34 % of patients
|
21 % of patients
|
|
Patient's Quality of Life
Doing activities that I am interested in
|
28 % of patients
|
21 % of patients
|
|
Patient's Quality of Life
Traveling out of town
|
45 % of patients
|
42 % of patients
|
|
Patient's Quality of Life
Maintaining a normal lifestyle
|
27 % of patients
|
24 % of patients
|
|
Patient's Quality of Life
Managing my daily schedule
|
21 % of patients
|
17 % of patients
|
|
Patient's Quality of Life
Keeping up with chores
|
26 % of patients
|
24 % of patients
|
|
Patient's Quality of Life
Being energetic
|
32 % of patients
|
28 % of patients
|
|
Patient's Quality of Life
Exercising
|
22 % of patients
|
20 % of patients
|
|
Patient's Quality of Life
Maintaining my weight
|
23 % of patients
|
21 % of patients
|
|
Patient's Quality of Life
Feeling healthy
|
26 % of patients
|
22 % of patients
|
|
Patient's Quality of Life
Feeling attractive
|
19 % of patients
|
17 % of patients
|
|
Patient's Quality of Life
Getting enough sleep
|
26 % of patients
|
22 % of patients
|
Adverse Events
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
Francesca Tentori
Arbor Research Collaborative for Health
Phone: 734-665-4108
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place