- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02034149
The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
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
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-
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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
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Sub-Investigator:
- Tsai-Chung Li, PhD.
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Sub-Investigator:
- Cheng-Chieh Lin, PhD
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Sub-Investigator:
- Fung-Chang Sung, PhD
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Sub-Investigator:
- Chiu-Shong Liu, doctor
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Sub-Investigator:
- Wen-Yuan Lin, PhD
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Sub-Investigator:
- Li-Chi Huang, PhD
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Sub-Investigator:
- Ya-Fei Yang, doctor
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Sub-Investigator:
- Chia-Ing Li, PhD
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Sub-Investigator:
- Wen-Chen Tsai, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
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:
|
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.
|
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:
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:
|
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.
|
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:
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in Renal function at 18 months
Time Frame: the baseline, 3rd, 6th, 12th and 18th 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
Time Frame: the baseline, 3rd, 6th, 12th and 18th 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
Time Frame: 18th months.
|
18th months.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Chiu-Ching Huang, doctor, Department of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMR100-IRB-206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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