NCT01348867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
Last Updated

June 24, 2015

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

May 4, 2011

Last Update Submit

June 23, 2015

Conditions

Diabetes

Keywords

DiabetesStructured Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • To assess the any changes in diabetic knowledge, behaviours and level self-efficacy of the participants as compared to the control patients

    12 months

  • A comparison of the patients' utility of healthcare services

    12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Structured Care

EXPERIMENTAL

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.

Other: Structured care led by a nurse consultant

Interventions

Structured care led by a nurse consultantOTHER

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.

Structured Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes & Endocrine Centre, Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rebecca Wong

    Prince of Wales Hospital, Shatin, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

June 24, 2015

Record last verified: 2011-05

Locations

HK(1)