Application Contract Management Mode in Maintaining PD Fluid Balance

The Second Affiliated Hospital of Harbin Medical University72 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Contract Management PD

Interventions

Contract managementBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: once a day, through study completion, an average of 6 months. changed from baseline

Data from ClinicalTrials.gov

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