Application Contract Management Mode in Maintaining PD Fluid Balance

NCT ID: NCT02782234

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

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.

Conditions

Contract Management PD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

not contract management

monthly follow-up phone or family visit completed as regulation, and instruct them proper healthy training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Contract management

Intervention Type: BEHAVIORAL

Interventions

Contract management

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Li Liu

Supervisor nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2 ndharbinmu

Identifier Type: -

Identifier Source: org_study_id