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).
Status | Recruiting |
Enrollment | 130 |
Est. completion date | June 30, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Hospital Authority | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of insulin acceptance | It is related to the proportion of participants who agree to be referred to insulin clinic for considering insulin initiation. | The acceptance is assessed on the same day of recruitment after education session has been provided to the participants. | |
Primary | Proportion of insulin initiation | It is related to the proportion of participants who agree to start insulin therapy after attending the insulin clinic. | For those participants who start insulin therapy in 6 months after the education session will be regarded as "insulin initiation". |
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