Type 2 Diabetes Clinical Trial
Official title:
Promoting Insulin Acceptance and Initiation With the Tailor-made Educational Intervention Among Type 2 Diabetic Patients With Sub-optimal Glycemic Control
Delay in commencing insulin among type 2 Diabetes Mellitus (T2DM) patients is common. One of
the reasons is patients' psychological insulin resistance (PIR), which is particularly
prevalent in Chinese patients. The Chinese Attitudes to Starting Insulin Questionnaire
(Ch-ASIQ) is the shortest locally validated questionnaire which is developed to understand
the condition of PIR in T2DM patients while brief motivational interviewing has been shown to
improve patients' collaborations and satisfactions, the alliance between patients and
doctors, and the treatment adherence. Therefore, this study aims to investigate the efficacy
of a one-session educational intervention targeting psychological insulin resistance guided
by Ch-ASIQ in promoting the insulin acceptance and initiation.
A quasi-experimental study will be conducted on 130 insulin-naïve T2DM patients recruited
from a primary care setting. Eligible participants in the intervention group will be treated
with one 15-minute brief motivational interviewing guided by Ch-ASIQ while those in control
group will be treated with usual care. Both groups will be further followed up for 6 months
to observe for their insulin initiation. The primary outcomes: i. the proportion of patient
referral to insulin clinic (insulin acceptance), and ii. the proportion of patient with
insulin initiation (actual start of insulin therapy).
Background Information According to the American Diabetes Association ADA (2018), insulin
treatment should not be delayed in patients with T2DM who fail to control their glycemic
level with OHAs. Delay in insulin therapy for such type of patients leads to excess glycemic
burden. A retrospective analysis of data showed that between 2005 and 2010, the time from
T2DM diagnosis to insulin initiation increased by approximately 2 years in the primary care
practices in Europe with increase in the percentage of patients with at least one
macrovascular complication. As known, once the developed macrovascular complications cannot
be reversed with tight glycemic control by any treatment. However, the initiation of the
insulin therapy is often delayed. This may be due to the reluctance among people with T2DM.
About half of the diabetic patients who are having suboptimal glycemic control for 3-5 years
and living with different extent of complications delay insulin therapy initiation. One of
the reasons is patients' psychological insulin resistance (PIR), which is describing the
reluctance to initiate insulin therapy, particularly prevalent in Chinese patients. In Hong
Kong, a local study has revealed a similarly high PIR prevalence of 72.1%.
Effective educational programmes are needed for insulin-naive patients to enhance their
understanding of the disease and treatment; and increase the acceptance and adherence of
insulin therapy. This calls for effective educational programmes to help those patients in
achieving better glycemic control in order to decrease risk of diabetic complications.
Brief Motivational Interviewing is an adaptation of motivational interviewing skills, which
is designed to apply in a time-constraint clinical care environment and has been shown to
improve patients' collaborations and satisfactions, the alliance between patients and
doctors, and the adherence to treatment. Although this is an effective communication style,
it has never been applied to educational programmes of insulin acceptance among T2DM patients
with sub-optimal glycemic control.
Trial Objectives and Purpose This trial is to examine the effectiveness of brief motivational
enhancement education programme in addition to usual care versus usual care only in improving
insulin acceptance and insulin initiation among T2DM patients with sub-optimal glycemic
control.
Trial Design To achieve the objectives, a quasi-experimental study on brief motivational
enhancement education programme will be conducted.
Selection and Withdrawal of Subjects
Subjects will be included in the trial if they are:
1. Diagnosed with T2DM for more than six months
2. Chinese patients who can speak Cantonese/Mandarin
3. Chinese patients who can read Chinese
4. Aged ≥ 18 years
5. Suboptimal glycemic control whose latest HbA1c ≥ 7.5% with maximum oral dosage of OHAs.
6. Never used insulin before and prescribed to start insulin therapy
People will be excluded if they are:
1. Physical or mental ill that hindered them from completing the questionnaire or
communicate, e.g., dementia, deafness, and severe visual problems
2. Pregnant
3. Gestational diabetic patients
People has the right to withdraw from the trial at any time without any impact on the current
medical services and legal rights.
The study will be conducted in one of the primary care setting of Hospital Authority, Ap Lei
Chau GOPC. Potential participants will be invited to participate when they are attending the
clinic for their regular follow-up appointment. Eligible participants will first be explained
the information sheet regarding the study. They will then be asked to sign the consent if
they are willing to join the study.
Treatment of Subjects The study target to recruit two groups of eligible cases. The two
groups will be recruited one by one. The first group recruited will act as control in
comparison. In this group, all eligible participants will be invited to complete the 13-items
Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) before they see nurses. After
having completed the questionnaires, they will be treated as usual care. The complications of
suboptimal diabetic control will be told, at the same time, diet control and importance of
regular exercise will also be reinforced as usual care. At the end of the session, they will
be asked if they accept the referral to the insulin clinic for insulin therapy.
The interventional group of eligible cases will be recruited after the control group reached
the pre-set numbers. In the interventional group, the eligible participants will be also
invited to complete the Ch-ASIQ before they see nurses. Besides the usual care, all the
participants in this group will also be treated with structured intervention. The information
gathered through the questionnaires will be used in the intervention for this group of
patients. The information will be delivered to the patients in the format of one 15-minute
session of brief motivational interviewing. Pre-set script will be used for the brief
motivational interviewing. At the end of the session, they will be asked if they accept the
referral to the insulin clinic for insulin therapy.
The first 10 cases in the intervention group will act as pilot. Intervention will be revised
if there are logistics problem seen.
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