Clinical trial NCT02782234: Application Contract Management Mode in Maintaining PD Fluid Balance
Official title: Application of Contract Management Mode in Maintaining Body Fluid Balance of Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contract Management PD
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volume of fluid intake and output keep in balance measured in ml.
timeFrame: 24 hours
measure: Change in Blood Pressure
timeFrame: two times a day, through study completion, an average of 6 months. changed from baseline
measure: Change in weight
timeFrame: once a day, through study completion, an average of 6 months. changed from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: