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Trial record 41 of 3342 for:    China Medicine University Hospital

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

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

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.




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. ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034149


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

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

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02034149     History of Changes
Other Study ID Numbers: DMR100-IRB-206
First Posted: January 13, 2014    Key Record Dates
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases