search
Back to results

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

Primary Purpose

Chronic Kidney Diseases, Chronic Kidney Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
general management
self-management
peer-assisted management
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, high risk, intervention, hypertension, hyperglycemia, hyperlipidemia

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

general management

self-management

peer-assisted management

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in Renal function at 18 months

Secondary Outcome Measures

Achievement of self management in drug compliance,exercise habit,balance diet at 18 months

Full Information

First Posted
November 29, 2013
Last Updated
July 31, 2014
Sponsor
China Medical University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT02034149
Brief Title
The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
Official Title
The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Chronic Kidney Insufficiency
Keywords
chronic kidney disease, high risk, intervention, hypertension, hyperglycemia, hyperlipidemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
411 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
general management
Arm Type
Other
Arm Description
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.
Arm Title
self-management
Arm Type
Experimental
Arm Description
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.
Arm Title
peer-assisted management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
general management
Other Intervention Name(s)
A general education.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
self-management
Other Intervention Name(s)
Self-managed interventions.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
peer-assisted management
Other Intervention Name(s)
the peer oriented group activities.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Renal function at 18 months
Time Frame
the baseline, 3rd, 6th, 12th and 18th months.
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Compliance to educational programs(exercise, drug, diet) in 18 months
Time Frame
18th months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Chieh Lin, doctor
Phone
886-4-22052121
Ext
4505
Email
a6446@mail.cmuh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Ching Huang, doctor
Organizational Affiliation
Department of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia-Ing Li, doctor
Phone
886-4-22052121
Ext
4505
Email
a6446@mail.cmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Chiu-Ching Huang, PhD
First Name & Middle Initial & Last Name & Degree
Tsai-Chung Li, PhD.
First Name & Middle Initial & Last Name & Degree
Cheng-Chieh Lin, PhD
First Name & Middle Initial & Last Name & Degree
Fung-Chang Sung, PhD
First Name & Middle Initial & Last Name & Degree
Chiu-Shong Liu, doctor
First Name & Middle Initial & Last Name & Degree
Wen-Yuan Lin, PhD
First Name & Middle Initial & Last Name & Degree
Li-Chi Huang, PhD
First Name & Middle Initial & Last Name & Degree
Ya-Fei Yang, doctor
First Name & Middle Initial & Last Name & Degree
Chia-Ing Li, PhD
First Name & Middle Initial & Last Name & Degree
Wen-Chen Tsai, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs