Can mCPN Intervention Improve Injection Site Rotation

NCT ID: NCT03914183

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2019-04-08

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

Conditions

Injection Site Rotation; Diabete Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard of care arm - using insulin pen needles as previously prescribed

Group Type: OTHER

Control

Intervention Type: DEVICE

Use of standard of care insulin pen needle

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.

Group Type: ACTIVE_COMPARATOR

mCPN Intervention

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Control

Use of standard of care insulin pen needle

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montméd

UNKNOWN

Sponsor Role: collaborator

Pink Pearls Inc

OTHER

Sponsor Role: lead

Responsible Party

Lori Berard

Nurse Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori Berard

Role: PRINCIPAL_INVESTIGATOR

Pink Pearls Inc

Locations

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

Northgate Pharmacy

Sarnia, Ontario, Canada

Murphy's Cornwall Pharmacy

Cornwall, Prince Edward Island, Canada

Pharmacie Jacques Bourget PJC076

Laval, Quebec, Canada

Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante

Montreal, Quebec, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

mCPN

Identifier Type: -

Identifier Source: org_study_id