Chronic Kidney DiseasesNCT02034149
The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
A study testing general management, self-management and peer-assisted management in people with Chronic Kidney Diseases and Chronic Kidney Insufficiency, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Kidney Insufficiency
- What is being tested?
- general management, self-management and peer-assisted management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 20 with chronic kidney disease (CKD) stage 1-3a patients and high-risk groups.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Chia-Ing Li, doctor, 886-4-22052121 ext. 4505, a6446@mail.cmuh.org.tw
Chiu-Ching Huang, PhD
About this study
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.
Read the 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.
- Being tested
- general management, self-management, peer-assisted management
- Keywords
- chronic kidney disease, high risk, intervention, hypertension, hyperglycemia, hyperlipidemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Hyperglycemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general managementBehavioural
Also called A general education.
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.
self-managementBehavioural
Also called Self-managed interventions.
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.
peer-assisted managementBehavioural
Also called the peer oriented group activities.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: general management; Behavioral: self-management; Behavioral: peer-assisted management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Renal function at 18 months
Measured: 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
Measured: the baseline, 3rd, 6th, 12th and 18th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chiu-Ching Huang, doctor, Study director, Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034149
- Sponsor's protocol ID
- DMR100-IRB-206
- Status last verified
- Jul 2014
- First submitted
- 29 Nov 2013
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cost Effectiveness and Evaluation of Disease Management of Chronic Kidney Disease and High Risk Population
- ClinicalTrials.gov ID
- NCT02034149
- Acronym / sponsor ID
- DMR100-IRB-206
- Keywords
- chronic kidney disease, high risk, intervention, hypertension, hyperglycemia, hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 411 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| general management | Other | Behavioral: general managementAll 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. |
| self-management | Experimental | Behavioral: general management, Behavioral: self-managementParticipants 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. |
| peer-assisted management | Experimental | Behavioral: general management, Behavioral: self-management, Behavioral: peer-assisted managementThe 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age greater than 20 with chronic kidney disease (CKD) stage 1-3a patients and high-risk groups.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general managementAlso: A general education.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. | Behavioural | general management, peer-assisted management, self-management |
| self-managementAlso: Self-managed interventions.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. | Behavioural | peer-assisted management, self-management |
| peer-assisted managementAlso: the peer oriented group activities.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. | Behavioural | peer-assisted management |
Primary outcome
Change from Baseline in Renal function at 18 months
Time frame: the baseline, 3rd, 6th, 12th and 18th months.
1 secondary outcome
Achievement of self management in drug compliance,exercise habit,balance diet at 18 months
Time frame: the baseline, 3rd, 6th, 12th and 18th months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiu-Ching Huang, doctor study director
Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general management, self-management and peer-assisted management in people with Chronic Kidney Diseases and Chronic Kidney Insufficiency, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Chieh Lin, doctor (886-4-22052121 ext. 4505, a6446@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Renal function at 18 months (time frame: the baseline, 3rd, 6th, 12th and 18th months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2014.