Effectiveness of a Treat-to-target Clinic Led by a Nurse Consultants

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348867
• Other study ID #: CRE-2009-394
• Status: Completed
• Phase: N/A
• First received: May 4, 2011
• Last updated: June 23, 2015
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: Asia Diabetes Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Diabetes & Endocrine Centre, Prince of Wales Hospital	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Asia Diabetes Foundation

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of the nurse consultant led clinic in improving glycemic parameters in patients with type 2 diabetes	Metabolic parameters such as HbA1c, blood pressure, lipid profile, body mass index (BMI) etc, will measured at specific time points throughout the study	12 months	No
Secondary	To assess the any changes in diabetic knowledge, behaviours and level self-efficacy of the participants as compared to the control patients	The cognitive psychosocial-behavior assessment will include using the Summary of Diabetes Self- Care Activities (SDSCA), Diabetes Empowerment Scale (DES), Depression Anxiety Stress Scale-21 (DASS21), General Health Questionnaire (GHQ12).	12 months	No
Secondary	A comparison of the patients' utility of healthcare services	The number of hospital admissions, total number of days stay in hospital, number of attendances at Accident and Emergency department will be explored and compared for all patients.	12 months	No

External Links

•   Works of the Asia Diabetes Foundation