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

• ClinicalTrials.gov Identifier: NCT02034149
• Recruitment Status: Unknown
• First Posted: January 13, 2014
• Last Update Posted: August 1, 2014
• Sponsor: China Medical University Hospital
• Collaborator: Ministry of Health and Welfare, Taiwan
• Information provided by (Responsible Party): China Medical University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases; Chronic Kidney Insufficiency	Behavioral: general management; Behavioral: self-management; Behavioral: peer-assisted management	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 411 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
• Study Start Date: January 2013
• Estimated Primary Completion Date: December 2014
• Estimated Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: the peer oriented group activities.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in Renal function at 18 months [ Time Frame: the baseline, 3rd, 6th, 12th and 18th months. ]

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Compliance to educational programs(exercise, drug, diet) in 18 months [ Time Frame: 18th months. ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Cheng-Chieh Lin, doctor; 886-4-22052121 ext 4505; a6446@mail.cmuh.org.tw

Locations

Taiwan

China Medical University Hospital; Recruiting

Taichung, Taiwan

Contact: Chia-Ing Li, doctor 886-4-22052121 ext 4505 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

Sponsors and Collaborators

China Medical University Hospital

Ministry of Health and Welfare, Taiwan

Investigators

• Study Director: Chiu-Ching Huang, doctor; Department of Medicine

More Information

• Responsible Party: China Medical University Hospital
• ClinicalTrials.gov Identifier: NCT02034149
• Other Study ID Numbers: DMR100-IRB-206
• First Posted: January 13, 2014
• Last Update Posted: August 1, 2014
• Last Verified: July 2014

Keywords provided by China Medical University Hospital:

chronic kidney disease; high risk; intervention; hypertension; hyperglycemia; hyperlipidemia

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Urologic Diseases