Type 2 Diabetes Clinical Trial
Official title:
The Effectiveness of Pre-medical Consultation (PMC) Diabetes Self-care Education Programme on Glycemic Control in Adults With Type 2 Diabetes
This proposed project is a prospective randomized controlled trial to examine the clinical effects of pre-medical consultation structured diabetes self-care education program on intervention group (IG) versus control group (CG) for patients with type 2 diabetes in a specialist outpatient clinic of a regional hospital.
Protocol Revised Date: 23 April 2019
Introduction Diabetes Mellitus (DM) is known as one of the major causes leading to
cardiovascular diseases, stroke, diabetes kidney diseases, blindness or non-traumatic lower
limb amputations. It is estimated that one in ten people to have diabetes and it has been
projected that one in three adults will develop type 2 diabetes by 2050. Similarly, the
prevalence of Type 2 Diabetes Mellitus (T2DM) in Hong Kong is estimated to be one in ten in
adult population.
DM is a progressive metabolic disease and necessitates continuous medical care, diabetes
self-management education and skills training to prevent or delay development of acute and
chronic complications. Educating patients with diabetes in self blood glucose monitoring,
healthy eating, regular physical activities, medication adherence, stress management and
smoking cessation are important behavioral modifications required in diabetes self-care
education. Besides providing education, diabetes nurses provide support and discuss with
patients regarding their concerns and worries about diabetes and empower them to live their
life positively with diabetes.
The Service Gap
Patients with diabetes with or without cardiovascular or renal comorbidities, are inevitably
a burden to healthcare system. In Hong Kong and most other countries, if not all, patients
are referred to specialist out-patient clinics (SOPC) for more advanced diabetes management
from either general out-patient clinics (GOPC) or private practitioners (GP). Hence, these
new case referrals from GOPC or GP are patients already have established DM on oral
anti-diabetic drugs and/or insulin injections and with diabetes complications. Nevertheless,
they have to wait for a long period of time, approximately one to two years before they could
be seen at SOPC.
The role of a diabetes nurse is recognized as providing diabetes education, individualized
care, self-care promotion, teaching physical skills and enhancing psychological support.
However, majority of DM patients are being first seen at general medical clinics, and only a
proportion of them will be referred by case medical practitioner to diabetes nurses for
education. In other words, the role of the diabetes nurses is quite 'passive' and the basic
education program may fail to cover all newly referred patients.
According to Hospital Authority (HA) report, the waiting time for stable case new case
booking in medicine specialist out-patient clinics from October 1, 2017 to September 30, 2018
is the median 94 weeks (= 24 months = 2 years) to the longest 119 weeks (= 30 months = 2.5
years) for first time medical consultation at SOPC. Most of them are with suboptimal glycemic
control and/or co-morbidities, such as retinopathy or renal impairment at time of referral
made and necessitate earlier medical management. Burden of diabetes on public health care
system in Hong Kong is alarming. The number of patients with diabetes increased over 9,000
(31.5%) in five years from 2010 to 2015, with around 200,000 admissions for diabetes-related
complications, which accounts for 18% of all admissions and around one million SOPC visits,
which accounts for 14% of all SOPC attendance.
Thus, the clinical triggers are:
1. What is the impact of delivering pre-medical consultation nursing intervention or
diabetes education to these newly referred patients with type 2 diabetes at SOPC?
2. What are the effects of early nursing consultation and diabetes self-care education on
glycemic control and self-care in patients with type 2 diabetes?
Hypothesis Pre-medical consultation structured diabetes self-care education programme can
provide significantly greater improvements in glycemic control and self-care behaviors in
adults with type 2 diabetes than usual care.
Objectives
1. To evaluate the effectiveness of pre-medical consultation structured diabetes self-care
education programme on glycemic control in adults with type 2 diabetes.
2. To assess the effectiveness of pre-medical consultation structured diabetes self-care
education programme on diabetes-specific self-care behaviors.
3. To examine acceptability and usefulness of the intervention protocol by conducting a
focus group interview on the intervention group.
Proposed evidence-based intervention protocol The findings of integrative review revealed
positive effects of diabetes education in improving glycemic control and promoting self-care
among adults with type 2 diabetes. An evidence-based protocol is developed based on these
findings to generate a structured diabetes self-care education programme for newly referred
patients before their first medical consultation at SOPC to improve glycemic control and
enhance self-care in adults with type 2 diabetes in Hong Kong.
Study design This will be a randomized controlled trial to examine the effects and
acceptability of a structured diabetes self-care education programme for type 2 diabetes
patients as an intervention group (IG) versus a control group (CG) of usual care in a
specialist out-patient clinic of a regional hospital.
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