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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Chronic Kidney Insufficiency
• Intervention / Treatment: Behavioral: general management; Behavioral: self-management; Behavioral: peer-assisted management

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 Type: Interventional
• Enrollment (Anticipated): 411
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Chieh Lin, doctor; Phone Number: 4505 886-4-22052121; Email: a6446@mail.cmuh.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Chia-Ing Li, doctor; Phone Number: 4505 886-4-22052121; Email: a6446@mail.cmuh.org.tw
    • Principal Investigator: Chiu-Ching Huang, PhD
    • Sub-Investigator: Tsai-Chung Li, PhD.
    • Sub-Investigator: Cheng-Chieh Lin, PhD
    • Sub-Investigator: Fung-Chang Sung, PhD
    • Sub-Investigator: Chiu-Shong Liu, doctor
    • Sub-Investigator: Wen-Yuan Lin, PhD
    • Sub-Investigator: Li-Chi Huang, PhD
    • Sub-Investigator: Ya-Fei Yang, doctor
    • Sub-Investigator: Chia-Ing Li, PhD
    • Sub-Investigator: Wen-Chen Tsai, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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. The effectiveness assessments have been set for the baseline, 3rd, 6th, 12th and 18th months.	Behavioral: 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.; Other Names: A general education.
Experimental: self-management; 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.With one year of intervention period, the 3 groups will be assessed at the 18th months of follow-up next year.	Behavioral: 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.; Other Names: A general education.; Behavioral: self-management; Participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with DVD courses. We negotiated their behavior change set goals for them etc.; Other Names: Self-managed interventions.
Experimental: peer-assisted management; The peer-assisted management group received the peer oriented group activities followed, including group discussions to share experience and sports map etc. With one year of intervention period, the 3 groups will be assessed at the 18th months of follow-up next year.	Behavioral: 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.; Other Names: A general education.; Behavioral: self-management; Participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with DVD courses. We negotiated their behavior change set goals for them etc.; Other Names: Self-managed interventions.; Behavioral: peer-assisted management; 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.; Other Names: the peer oriented group activities.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Compliance to educational programs(exercise, drug, diet) in 18 months	18th months.

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Ministry of Health and Welfare, Taiwan
• Investigators: Study Director: Chiu-Ching Huang, doctor, Department of Medicine

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 29, 2013
• First Submitted That Met QC Criteria: January 10, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 31, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: hypertension; chronic kidney disease; intervention; hyperglycemia; high risk; hyperlipidemia
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: DMR100-IRB-206