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

NCT ID: NCT01348867

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

These 120 controls will undergo a comprehensive assessment at baseline then again at 12 months, which is similar to the intervention group. However, in between these 2 time points the 'control' patients will receive usual care and hence will not be monitored under the structured care protocol by a diabetes nurse consultant led team.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Structured Care

120 patients will be randomised to the structured care group, and these patients will receive repeated follow-ups and contact with the structured care team in between the two comprehensive assessments at week 0 and week 52.

Patients will be seen by Diabetes Nurse Consultant at week 0, 6, 12, 24 38 during the year. At each visit, clinical and laboratory measurements will be performed; treatment compliance and self care will be assessed and medications will be adjusted to optimise metabolic and cardiovascular risk factors control.

Patients will be seen by the doctors in their clinic follow up at week 0, 24 and 52.

Technical service assistance will telephone patient at week 18, 30 and 44 to reinforce patient to take medications, attend clinical follow up.

Group Type: EXPERIMENTAL

Structured care led by a nurse consultant

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asia Diabetes Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Wong

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital, Shatin, Hong Kong

Locations

Diabetes & Endocrine Centre, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Countries

Hong Kong

Related Links

http://www.adf.org.hk

Works of the Asia Diabetes Foundation

Other Identifiers

CRE-2009-394

Identifier Type: -

Identifier Source: org_study_id