Clinical trial NCT02034149: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Chronic Kidney Insufficiency
Keywords: chronic kidney disease
high risk
intervention
hypertension
hyperglycemia
hyperlipidemia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2014-01-13
Enrollment: 411
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from Baseline in Renal function at 18 months
timeFrame: the baseline, 3rd, 6th, 12th and 18th months.
Secondary outcomes:
measure: Achievement of self management in drug compliance,exercise habit,balance diet at 18 months
timeFrame: the baseline, 3rd, 6th, 12th and 18th months.
Other outcomes:
measure: Compliance to educational programs(exercise, drug, diet) in 18 months
timeFrame: 18th months.
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Department of Medicine
name: Chiu-Ching Huang, doctor
role: STUDY_DIRECTOR
References: