Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 24
- 主要终点
- The percentage of participants in the mCPN group who demonstrate an improvement (vs baseline performance) in the recommended site rotation techniques relative to the proportion of that in the control group.
研究概览
简要总结
The current research study has accordingly been designed to determine if a "pharmacist-dispensed montméd Coloured Pen Needle (mCPN) intervention" will improve injection site rotation relative to the standard dispensing of non-mCPN insulin pen needles.
详细描述
Study Design and Conduct This is a 30-day, two-arm, randomized, controlled study.
Enrolled participants will be randomly assigned to one of the following study arms:
- Control group: participating pharmacists will dispense boxes of standard insulin pen needles to the patient participants
- mCPN group: participating pharmacists will dispense boxes of montméd Coloured Pen Needles to the patient participants
Study Sites and Participating Pharmacists All pharmacies in Canada that provide services to individuals with diabetes who use injectable insulin therapy will be eligible to participate in this study. All participating pharmacists who will play an active role in participant enrollment and the follow-up visits will be required to complete a participation consent form and 2 surveys. The first (Pre-study survey) should be completed after they have been fully trained on the study protocol and their study obligations, and before commencement of study enrollment. The second (Post-study survey) should be completed after the last patient has completed the 30-day follow-up visit. (Refer to Section 11 for the Study Flow).
Randomization Process Participating pharmacists will dispense one of the two study pen needles according to a computer-generated list that will be provided to the participating pharmacy upon site activation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 1 diabetes mellitus or type 2 diabetes mellitus who have been using daily insulin therapy for 1 year or more
- •Able to read the English text on the boxes of the pen needles
排除标准
- •Individuals currently treated with a glucagon-like peptide 1 receptor agonist (GLP-1RA)
- •Current or previous user of mCPN
- •Individuals who are unable to understand or communicate in English
- •Pregnant women
- •Individuals with serious mental illnesses eg. dementia, schizophrenia disorders, bipolar disorders, major depression, etc.
研究组 & 干预措施
Control
Standard of care arm - using insulin pen needles as previously prescribed
干预措施: Control (Device)
mCPN intervention
Each box of montméd Coloured Pen Needles (mCPN) has the following five features:
i. Distinctively coloured pen needles ii. A user-defined association tool which is intended to help the patient associate each colour to a specific injection zone iii. A concise and intuitive educational message "Change color, change site" siteTM" iv. Unique packaging with educational content v. Four distinctive message-in-a-box educational sound-chips which serve to reinforce the recommended educational message on site rotation at home and come on every tenth time the pen needle box is opened The current research study has accordingly been designed to determine if a "pharmacist-dispensed montméd Coloured Pen Needle (mCPN) intervention" will improve injection site rotation relative to the standard dispensing of non-mCPN insulin pen needles.
干预措施: mCPN Intervention (Device)
结局指标
主要结局
The percentage of participants in the mCPN group who demonstrate an improvement (vs baseline performance) in the recommended site rotation techniques relative to the proportion of that in the control group.
时间窗: 30 - 45 days
次要结局
- Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling(Study duration 30 to 90 days)
- the percentage of participating patients who decide to continue using mCPN upon study completion(30- 45 days)
- Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation(Study duration. 30 to 90 days)
- increase/change in injection zone size(30-45 days)
- percentage of participating patients who change their needles more often (patient reported),(30 - 45 days)
研究者
Lori Berard
Nurse Consultant
Pink Pearls Inc