Trial Outcomes & Findings for Dietary Education Intervention Impact on Dietary Protein Intake in PD (NCT NCT02426580)
NCT ID: NCT02426580
Last Updated: 2019-07-10
Results Overview
We use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg\*d).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
12 months
Results posted on
2019-07-10
Participant Flow
Patients were retrospectively from January 2014 to January 2015 and prospectively enrolled from Apr. 2015 to Apr. 2017 in the control group. Patients were prospectively enrolled in intervention with wechat group from Apr. 2015 to Apr. 2017.
Participant milestones
| Measure |
Intervention With Wechat Group
The wechat model will provide information of protein, calcium, phosphorus and protein intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone
|
Controlled Group
Only conventional education every 3 months during routing clinical visit
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
59
|
54
|
|
Overall Study
NOT COMPLETED
|
11
|
16
|
Reasons for withdrawal
| Measure |
Intervention With Wechat Group
The wechat model will provide information of protein, calcium, phosphorus and protein intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone
|
Controlled Group
Only conventional education every 3 months during routing clinical visit
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
9
|
|
Overall Study
transfer to hemodialysis
|
5
|
5
|
|
Overall Study
Kidney transplant
|
3
|
0
|
|
Overall Study
Allergic to egg white
|
1
|
0
|
Baseline Characteristics
Dietary Education Intervention Impact on Dietary Protein Intake in PD
Baseline characteristics by cohort
| Measure |
Intervention With Wechat Group
n=59 Participants
The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone
|
Controlled Group
n=54 Participants
Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
46.3390 years
STANDARD_DEVIATION 13.8621 • n=99 Participants
|
48.0926 years
STANDARD_DEVIATION 13.3985 • n=107 Participants
|
47.17699 years
STANDARD_DEVIATION 13.61015 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
59 participants
n=99 Participants
|
54 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Normalized Protein Catabolic Rate (nPCR)
|
0.889 g/(Kg*d)
STANDARD_DEVIATION 0.202 • n=99 Participants
|
0.862 g/(Kg*d)
STANDARD_DEVIATION 0.186 • n=107 Participants
|
0.876 g/(Kg*d)
STANDARD_DEVIATION 0.194 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsWe use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg\*d).
Outcome measures
| Measure |
Intervention With Wechat Group
n=59 Participants
The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone
|
Controlled Group
n=54 Participants
Only conventional education every 3 months during routing clinical visit
|
|---|---|---|
|
Normalized Protein Catabolic Rate (nPCR)
|
1.038 g/(kg*d)
Standard Deviation 0.188
|
0.930 g/(kg*d)
Standard Deviation 0.175
|
Adverse Events
Intervention With Wechat Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Controlled Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention With Wechat Group
n=70 participants at risk
The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline.
wechat: The wechat model of dietary education every 1 month by cellphone
|
Controlled Group
n=70 participants at risk
Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled
|
|---|---|---|
|
Gastrointestinal disorders
Egg white allergy
|
1.4%
1/70 • Number of events 1 • 1 year
During the observation period of one year, all the enrolled participants were followed up per 1 to 3 months. And we recorded their disease status such as hospitalization, peritonitis, abdominal pain, rash and death.
|
0.00%
0/70 • 1 year
During the observation period of one year, all the enrolled participants were followed up per 1 to 3 months. And we recorded their disease status such as hospitalization, peritonitis, abdominal pain, rash and death.
|
Additional Information
Dr. Gong Rong, Dr. Han Tianzhao, Dr. Leonard Stern
The Nephrology Department, the Chengdu Second Affiliated Hospital of Chongqing Medical University, the Third Peoples's Hospital of Chengdu
Phone: +86 028-61318708
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place