Effectiveness of a Treat-to-target Clinic Led by a Nurse Consultants
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 4, 2011 | ||||
| Last Updated Date | May 5, 2011 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To assess the effectiveness of the nurse consultant led clinic in improving glycemic parameters in patients with type 2 diabetes [ Time Frame: 12 months ] [ Designated as safety issue: No ] Metabolic parameters such as HbA1c, blood pressure, lipid profile, body mass index (BMI) etc, will measured at specific time points throughout the study |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01348867 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of a Treat-to-target Clinic Led by a Nurse Consultants | ||||
| Official Title ICMJE | A Randomised Study to Evaluate the Effectiveness of a Treat-to-target Clinic Led by a Nurse Consultant in Managing Patients With Type 2 Diabetes in Hong Kong | ||||
| Brief Summary | The investigators hypothesize a diabetes nurse consultant led team with particular emphasis on compliance and attainment of treatment targets in Type 2 diabetic patients will achieve metabolic control, improve clinical outcomes and levels of self efficacy compared to usual clinic-based care. |
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| Detailed Description | Diabetes patients consume over 10% of health care costs in most developed countries. Over 80% of these resources are used to treat diabetic complications and late stage diseases. In Hong Kong, the prevalence of diabetes was reported to be 10%. Over 30% of patients admitted to the medical wards in Hong Kong's public hospitals have diabetes, mainly due to cardiovascular and renal complications. The number of patients receiving renal replacement therapy has increased by 50% in the last 5 years but the number of patients with end stage renal disease due to diabetes has doubled. Between 10% and 15% of patients attending medical clinics in local public hospitals either receive insulin or anti-diabetic drugs. Local published data show that 3-10% of diabetic patients died or developed clinical endpoints yearly. There are now overwhelming evidence supporting the beneficial effects of optimal control of cardiovascular risk factors on clinical outcomes in diabetic patients. However, there are few studies to examine the most effective way to translate these evidence collected in closely monitored clinical trials situations into daily clinical practice. Against this background, the investigators hypothesize that disease management using a team approach to implement a structured care model in daily clinical practice will improve the clinical outcomes in high risk Type 2 diabetic patients compared to usual clinic-based care with no specific built in protocol and/or monitoring mechanism to ensure its effective implementation. The nurse consultant led clinics will use a structured protocol with particular emphasis on periodic monitoring, treating to target and reinforcing patient adherence. In light of the size of diabetes epidemic, the constraints of finite resources and the need for equity, the investigators propose the results from this randomized study will provide information to health care policy makers regarding the effectiveness of diabetes nurse consultant led clinics in managing diabetic patients. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Diabetes | ||||
| Intervention ICMJE | Other: Structured care led by a nurse consultant
For the intervention group, patients will be followed up according to the following protocol. The structured care team consists of: i) Diabetes Nurse Consultant to reinforce compliance; educate patients on insulin injection techniques and reinforce self-care including self blood glucose monitoring and lifestyle interventions, titration of medication. ii) Technical Service Assistance to remind patients to take medications and/or give insulin injection, monitor blood glucose as prescribed, attend their next clinic appointment, encourage patients to report all side effects, self initiated change in regimen or concerns to diabetes nurse consultant and/or their doctors at the next follow up visit. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01348867 | ||||
| Other Study ID Numbers ICMJE | CRE-2009-394 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Dr. Rebecca Wong, Department of Therapeutics, Prince of Wales Hospital | ||||
| Study Sponsor ICMJE | Asia Diabetes Foundation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asia Diabetes Foundation | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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