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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01348867
Enrollment
242
Registered
2011-05-06
Start date
2009-03-31
Completion date
2010-12-31
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Structured 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.

Interventions

OTHERStructured 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.

Sponsors

Asia Diabetes Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To assess the effectiveness of the nurse consultant led clinic in improving glycemic parameters in patients with type 2 diabetes12 monthsMetabolic parameters such as HbA1c, blood pressure, lipid profile, body mass index (BMI) etc, will measured at specific time points throughout the study

Secondary

MeasureTime frameDescription
To assess the any changes in diabetic knowledge, behaviours and level self-efficacy of the participants as compared to the control patients12 monthsThe 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).
A comparison of the patients' utility of healthcare services12 monthsThe 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026