Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a prospective randomized controlled pilot trial/(a combined prospective and retrospective study). The investigators will use wechat intervening dietary protein intake in patients treated with peritoneal dialysis.
Malnutrition is highly prevalent in peritoneal dialysis (PD) patients, and protein malnutrition will adversely affect outcomes. The investigators develop a dietary education intervention for PD patients to improve fundamental food knowledge that will increase protein intake to target level of 1.2 g/kg of protein intake per day. In additional the dietary intervention will provide information about sodium, phosphorus, calcium intake. To more effectively deliver the intervention, the investigators explored a technology using social media in China called wechat. The purpose of this study is to test whether a dietary intervention can be more effective when delivered using wechat compared to a traditional patient education intervention delivered during routing clinical visits.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with wechat group | Experimental | The wechat model will provide information of protein, calcium, phosphorus and sodium intake, which were suggested by the current KDIGO/ KDOQI guideline. |
|
| Controlled group | No Intervention | Only conventional education every 3 months during routing clinical visit |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | The wechat model of dietary education every 1 month by cellphone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalized Protein Catabolic Rate (nPCR) | 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). | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
We would like to share the study protocol, study reports and informed consent form with other researchers.
The data will become available at May 2019 and for 2 years
No criteria.
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Controlled Group | Only conventional education every 3 months during routing clinical visit |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
11 (11/70, 15.71%) dropped out from intervention group and 16 (16/70, 22.86%) dropped out from control group; the rest of participants finished the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention With Wechat Group | 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 |
| BG001 | Controlled Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Normalized Protein Catabolic Rate (nPCR) | 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). | Posted | Mean | Standard Deviation | g/(kg*d) | 12 months |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention With Wechat Group | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Egg white allergy | Gastrointestinal disorders | Non-systematic Assessment | In the intervention with wechat group, Only 1 patient had abdominal pain after eating egg white. And we considered this symptom caused by egg white allergy. Therefore, this patient excluded from the study |
It is not a randomized controlled study. The patients assigned to both groups according to their willing. Most enrolled to intervention group. To improve the amount of control group, we retrospectively recruited 35 patients from recent 1 year.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 | +86 028-61318708 | gongr2006@sina.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2017 | Mar 15, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| transfer to hemodialysis |
|
| Kidney transplant |
|
| Allergic to egg white |
|
Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | inquire of patients about race | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Normalized Protein Catabolic Rate (nPCR) | 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). | Mean | Standard Deviation | g/(Kg*d) |
|
|
|
| 2 |
| 70 |
| 0 |
| 70 |
| 1 |
| 70 |
| EG001 | Controlled Group | Only conventional education every 3 months during routing clinical visit. The patients is Prospectively and retrospectively enrolled | 2 | 70 | 0 | 70 | 0 | 70 |
|
Not provided
Not provided