Application Contract Management Mode in Maintaining PD Fluid Balance (ACMMPDFB)

Application of Contract Management Mode in Maintaining Body Fluid Balance of Peritoneal Dialysis Patients

Contract management is a new management mode.

To help patients achieve fluid balance through contract management, that is:

1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；
3. Fluid intake and output keep in balance;
4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

Study Overview

• Status: Unknown
• Conditions: Contract Management PD
• Intervention / Treatment: Behavioral: Contract management

Detailed Description

Contract management is a new management mode, it stipulate and constraint various relationship by various duties, institutions and regulations.

To help patients achieve fluid balance through contract management, that is:

1. edema, congestive heart failure and other similar symptoms begin to reduce to disappear;
2. Blood pressure control in normal range, that is 90-140/60-90mmHg, or the target value prescribed by the doctors；
3. Fluid intake and output keep in balance;
4. No imbalance symptoms turn out, such as edema, congestive heart failure, etc.

In addition to help keeping the fluid balance through contract balance, but also:

1. Improve compliance;
2. Improve the patients' cognition of fluid balance;
3. Improve the ability of self-management of fluid balance.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Older or equal to 18 years, younger or equal to 65 years, CAPD duration over 6 months
2. Edema or congestive heart failure happen
3. Patients with poor control of blood pressure, that is less than 90/60mmHg,or over 140/90mmHg, or the Bp does not meet the value given by doctors
4. Patients with fluid imbalance of intake and output.

Exclusion Criteria:

1. Younger than 18, or older than 65, or CAPD period less than 6 months
2. The primary disease is high blood pressure, or edema due to low protein
3. Patients that lost control of daily life
4. Malignant tumor or pregnancy
5. Falling in Chronic infection or severe complication within 1 month, such as hepatic disease, hemorrhage of digestive tract, etc.
6. Patients with cognition impairment, conscious disorder, or mental disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: not contract management; monthly follow-up phone or family visit completed as regulation, and instruct them proper healthy training.
Experimental: Contract management; In accordance with the contract content, researchers and participants should manage and maintain the liquid balance of the participants. Signed doctors and nurses should undergo the follow-up phone or family visit on time, instruct them proper healthy training, and provided necessary information data. By telephone, SMS, wechat, remind and urge the participants to take the lifestyle and behavior regulate in the contract. Participants should supervise and manage the fluid unbalance (Edema, hypertension, heart failure, and fluid imbalance of intake and output etc.), and feedback the Management and supervision to researchers according to contract.	Behavioral: Contract management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of fluid intake and output keep in balance measured in ml.	as the physiological parameter for this Outcome. Volume measurement unit should be used in pd subjects, the unit ml.	24 hours
Change in Blood Pressure	two times a day, blood pressure measure at a.m.6∶0 0～ 8∶0 0 ,p.m.15∶0 0～ 18∶0 0. The subjects for the first time measuring blood pressure for the baseline.	two times a day, through study completion, an average of 6 months. changed from baseline
Change in weight	The subjects for the first time measuring weight for the baseline measured in kg.	once a day, through study completion, an average of 6 months. changed from baseline

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 24, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2 ndharbinmu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO