Can mCPN Intervention Improve Injection Site Rotation

Not Applicable

Completed

• Conditions: Injection Site Rotation; Diabete Mellitus

• Registration Number: NCT03914183
• Lead Sponsor: Pink Pearls Inc

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2018-10-15
• Status Verified: 2019-04
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-10
• Last Update Submitted: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	30 - 45 days

Secondary Outcome Measures

Name	Time	Method
Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling	Study duration 30 to 90 days	The change in the level of confidence in providing injection site rotation counselling (Confidence Scale) using a 5 point likert scale: Not confident (1) Little Confidence (2)Neither (3) Somewhat Confident (4) Very confident (5)
the percentage of participating patients who decide to continue using mCPN upon study completion	30- 45 days	Willingness to continue with intervention needle from post survey - patient reported
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	The change the level of knowledge about the importance of site rotation as (importance scale) as measured by a 5 point likert scale; Unimportant (1) Slightly Important (2) Neither (3) Slightly Important (4) Very Important (5)
increase/change in injection zone size	30-45 days	Assessment of injection rotation from pre to post survey patient reported
percentage of participating patients who change their needles more often (patient reported),	30 - 45 days	Assessment of needle reuse or lack of reuse from pre to post survey patient reported

Trial Locations

Locations (14)

Shoppers Drug Mart 2335; 🇨🇦 Calgary, Alberta, Canada

Claresholm Pharamcy; 🇨🇦 Claresholm, Alberta, Canada

Rexall 7236; 🇨🇦 Edmonton, Alberta, Canada

Shoppers Drug Mart 2401; 🇨🇦 Okotoks, Alberta, Canada

Kipp Mallery Pharmacy; 🇨🇦 Kamloops, British Columbia, Canada

Our Own Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Shoppers Drug Mart 535; 🇨🇦 Winnipeg, Manitoba, Canada

Kennegecasis Drugs; 🇨🇦 Rothesay, New Brunswick, Canada

Zak's Pharmacy; 🇨🇦 Milton, Ontario, Canada

Niagara Pharmacy; 🇨🇦 Niagara Falls, Ontario, Canada

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