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

NCT02034149 | Unknown DMC

• 1 other identifier: DMR100-IRB-206
• Study Type: interventional
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Chronic Kidney Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Renal function at 18 months

  the baseline, 3rd, 6th, 12th and 18th months.

Secondary Outcomes (1)

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

  the baseline, 3rd, 6th, 12th and 18th months.

Other Outcomes (1)

• Compliance to educational programs(exercise, drug, diet) in 18 months

  18th months.

Study Arms (3)

general management

OTHER

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

self-management

EXPERIMENTAL

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; Behavioral: self-management

peer-assisted management

EXPERIMENTAL

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; Behavioral: self-management; Behavioral: peer-assisted management

Interventions

general management BEHAVIORAL

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.

Also known as: A general education.

general management; peer-assisted management; self-management

self-management BEHAVIORAL

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.

Also known as: Self-managed interventions.

peer-assisted management; self-management

peer-assisted management BEHAVIORAL

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.

Also known as: the peer oriented group activities.

peer-assisted management

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 20 with chronic kidney disease (CKD) stage 1-3a patients and high-risk groups.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Hyperglycemia; Hyperlipidemias

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Chiu-Ching Huang, doctor

  Department of Medicine

  STUDY DIRECTOR

Central Study Contacts

Cheng-Chieh Lin, doctor

CONTACT

886-4-22052121; a6446@mail.cmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2013
• First Posted: January 13, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

TW (1)