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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02034149
Enrollment
411
Registered
2014-01-13
Start date
2013-01-31
Completion date
2014-12-31
Last updated
2014-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Chronic Kidney Insufficiency

Keywords

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

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.

Interventions

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.

BEHAVIORALself-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.

BEHAVIORALpeer-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.

Sponsors

Ministry of Health and Welfare, Taiwan
CollaboratorOTHER_GOV
China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Renal function at 18 monthsthe baseline, 3rd, 6th, 12th and 18th months.

Secondary

MeasureTime frame
Achievement of self management in drug compliance,exercise habit,balance diet at 18 monthsthe baseline, 3rd, 6th, 12th and 18th months.

Other

MeasureTime frame
Compliance to educational programs(exercise, drug, diet) in 18 months18th months.

Countries

Taiwan

Contacts

Primary ContactCheng-Chieh Lin, doctor
a6446@mail.cmuh.org.tw886-4-22052121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026