Clinical trial NCT01348867: Effectiveness of a Treat-to-target Clinic Led by a Nurse Consultants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Structured Care
Lead sponsor: Asia Diabetes Foundation
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients
* Aged between 18 and 75 years (inclusive)
* HbA1c \>8%
* Chinese in ethnicity
* patients under the care of clinicians who aimed the treatment targets of their patients as HbA1c \<7%, BP \<130/80 mmHg, and LDL-C \<2.6 mmol/L

Exclusion Criteria:

* patients with clinically unstable psychiatric illnesses
* patients with terminal malignancy or other life-threatening diseases with less than 3-month expected survival
* patients who speak non-Cantonese dialect or a different language or have conditions that prevent effective face-to-face or telephone communications eg. Patients who are deaf or mute
* patients who live in nursing home with supervised treatment
* patients who are not available via telephone contact

Primary outcomes:
measure: To assess the effectiveness of the nurse consultant led clinic in improving glycemic parameters in patients with type 2 diabetes
timeFrame: 12 months
Secondary outcomes:
measure: To assess the any changes in diabetic knowledge, behaviours and level self-efficacy of the participants as compared to the control patients
timeFrame: 12 months
measure: A comparison of the patients' utility of healthcare services
timeFrame: 12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Diabetes & Endocrine Centre, Prince of Wales Hospital
state: New Territories
Study officials:
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Rebecca Wong
role: PRINCIPAL_INVESTIGATOR
References: