Promoting Insulin Acceptance and Initiation With the Tailor-made Educational Intervention Among Type 2 Diabetic Patients With Sub-optimal Glycemic Control
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Proportion of insulin acceptance
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Participant does not know which group they are assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be included in the trial if they are:
- •Diagnosed with T2DM for more than six months
- •Chinese patients who can speak Cantonese/Mandarin
- •Chinese patients who can read Chinese
- •Aged ≥ 18 years
- •Suboptimal glycemic control whose latest HbA1c ≥ 7.5% with maximum oral dosage of OHAs.
- •Never used insulin before and prescribed to start insulin therapy
排除标准
- •People will be excluded if they are:
- •Physical or mental ill that hindered them from completing the questionnaire or communicate, e.g., dementia, deafness, and severe visual problems
- •Gestational diabetic patients
结局指标
主要结局
Proportion of insulin acceptance
时间窗: The acceptance is assessed on the same day of recruitment after education session has been provided to the participants.
It is related to the proportion of participants who agree to be referred to insulin clinic for considering insulin initiation.
Proportion of insulin initiation
时间窗: For those participants who start insulin therapy in 6 months after the education session will be regarded as "insulin initiation".
It is related to the proportion of participants who agree to start insulin therapy after attending the insulin clinic.
次要结局
未报告次要终点
研究者
Echo Ting-Ting Go
Doctoral Candidate
The University of Hong Kong