Can mCPN Intervention Improve Injection Site Rotation

NCT03914183 | Completed

• 1 other identifier: mCPN
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 14

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.

Conditions

Injection Site Rotation; Diabete Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling

  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

• the percentage of participating patients who decide to continue using mCPN upon study completion

  30- 45 days

Study Arms (2)

Control

OTHER

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

Device: Control

mCPN intervention

ACTIVE COMPARATOR

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.

Device: mCPN Intervention

Interventions

mCPN Intervention 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

mCPN intervention

Control DEVICE

Use of standard of care insulin pen needle

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pink Pearls Inc: lead
• Montméd: collaborator

Study Sites (14)

Shoppers Drug Mart 2335

Calgary, Alberta, T2X3X7, Canada

Location

Claresholm Pharamcy

Claresholm, Alberta, T0L0T0, Canada

Location

Rexall 7236

Edmonton, Alberta, T5Z0H5, Canada

Location

Shoppers Drug Mart 2401

Okotoks, Alberta, T1S2N3, Canada

Location

Kipp Mallery Pharmacy

Kamloops, British Columbia, V2C0B6, Canada

Location

Our Own Health Centre

Winnipeg, Manitoba, R3B 0T2, Canada

Location

Shoppers Drug Mart 535

Winnipeg, Manitoba, R3L1Y2, Canada

Location

Kennegecasis Drugs

Rothesay, New Brunswick, Canada

Location

Zak's Pharmacy

Milton, Ontario, Canada

Location

Niagara Pharmacy

Niagara Falls, Ontario, Canada

Location

Northgate Pharmacy

Sarnia, Ontario, N7T5P5, Canada

Location

Murphy's Cornwall Pharmacy

Cornwall, Prince Edward Island, C0A1H0, Canada

Location

Pharmacie Jacques Bourget PJC076

Laval, Quebec, Canada

Location

Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante

Montreal, Quebec, H4E 3J2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lori Berard

  Pink Pearls Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Consultant

Model Details: Open label randomized control study of control (current standard of care) versus mCPN intervention

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 16, 2019
• Study Start: October 15, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)