The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population

Not Applicable

• Conditions: Chronic Kidney Insufficiency; Chronic Kidney Diseases

• Registration Number: NCT02034149
• Lead Sponsor: China Medical University Hospital

Brief Summary

This study is being implemented for 3 aims. The first has been to conduct a systematic literatures review on CKD intervention models and their effectiveness. Findings have been adopted in our intervention program. The second purpose is to establish a practical management model or an intervention model for CKD patients and high risk population with the 18-month of follow-up.In the third year, we will use social perspective point to evaluate the costs and the benefits of intervention.

Detailed Description

The object of the study is by screening for adults (20 years) with chronic kidney disease (CKD stage 1-3a) and high-risk groups. They were randomly assigned into experimental groups (self management and peer-assisted management) and control group (general management). All participants received a general education with the knowledge on care for early chronic kidney disease recently establishes by the National Health Insurance system. We then used the cross-theoretical model to assess the intervention among the three groups.

We collected information on baseline and follow-up data on biochemical and physiological check-ups, health promotion behavior, dietary intake status, self-efficacy and cost etc. Information on behavior changes, including smoking, chewing betel nut, medication, exercise and diet, was also collected and assessed. Participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with digital video disc (DVD) courses. We negotiated their behavior change set goals for them etc. The peer-assisted management group received similar program for 3 months, the peer oriented group activities followed, including group discussions to share experience and sports map etc. The effectiveness assessments have been set for the baseline, 3rd, 6th, 12th and 18th months. With one year of intervention period, the 3 groups will be assessed at the 18th months of follow-up next year.

In the third year, we will use social perspective point to evaluate the costs and benefits of intervention. We suppose that a 100,000 people to screen out cases of chronic kidney disease (CKD stage 1-3a) and high-risk groups, and we will compare the cost-effectiveness analysis between the experimental group with accept the intervention for 12 months to the control groups without receiving extra intervention.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

• Age greater than 20 with chronic kidney disease (CKD) stage 1-3a patients and high-risk groups.

Exclusion Criteria

• Inability to communicate in Chinese.
• Lack of capacity to write in Chinese.
• Ongoing treatment in dialysis.
• Suffering from major diseases.
• Treatment in cancer or suffering from cancer less than two years.
• Have received organ transplants or bone marrow transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Renal function at 18 months	the baseline, 3rd, 6th, 12th and 18th months.

Secondary Outcome Measures

Name	Time	Method
Achievement of self management in drug compliance,exercise habit,balance diet at 18 months	the baseline, 3rd, 6th, 12th and 18th months.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan