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Can mCPN Intervention Improve Injection Site Rotation

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ClinicalTrials.gov Identifier: NCT03914183
Recruitment Status : Completed
First Posted : April 15, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Montméd
Information provided by (Responsible Party):
Lori Berard, 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.

Condition or disease Intervention/treatment Phase
Injection Site Rotation Diabete Mellitus Device: mCPN Intervention Device: Control Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomized control study of control (current standard of care) versus mCPN intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Control
Standard of care arm - using insulin pen needles as previously prescribed
Device: Control
Use of standard of care insulin pen needle

Active Comparator: 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.

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





Primary Outcome Measures :
  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. [ Time Frame: 30 - 45 days ]

Secondary Outcome Measures :
  1. Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation [ Time Frame: 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)

  2. Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling [ Time Frame: 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)

  3. increase/change in injection zone size [ Time Frame: 30-45 days ]
    Assessment of injection rotation from pre to post survey patient reported

  4. percentage of participating patients who change their needles more often (patient reported), [ Time Frame: 30 - 45 days ]
    Assessment of needle reuse or lack of reuse from pre to post survey patient reported

  5. the percentage of participating patients who decide to continue using mCPN upon study completion [ Time Frame: 30- 45 days ]
    Willingness to continue with intervention needle from post survey - patient reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914183


Locations
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Canada, Alberta
Shoppers Drug Mart 2335
Calgary, Alberta, Canada, T2X3X7
Claresholm Pharamcy
Claresholm, Alberta, Canada, T0L0T0
Rexall 7236
Edmonton, Alberta, Canada, T5Z0H5
Shoppers Drug Mart 2401
Okotoks, Alberta, Canada, T1S2N3
Canada, British Columbia
Kipp Mallery Pharmacy
Kamloops, British Columbia, Canada, V2C0B6
Canada, Manitoba
Our Own Health Centre
Winnipeg, Manitoba, Canada, R3B 0T2
Shoppers Drug Mart 535
Winnipeg, Manitoba, Canada, R3L1Y2
Canada, New Brunswick
Kennegecasis Drugs
Rothesay, New Brunswick, Canada
Canada, Ontario
Zak's Pharmacy
Milton, Ontario, Canada
Niagara Pharmacy
Niagara Falls, Ontario, Canada
Canada, Ont
Northgate Pharmacy
Sarnia, Ont, Canada, N7T5P5
Canada, PEI
Murphy's Cornwall Pharmacy
Cornwall, PEI, Canada, C0A1H0
Canada, Quebec
Pharmacie Jacques Bourget PJC076
Laval, Quebec, Canada
Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante
Montreal, Quebec, Canada, H4E 3J2
Sponsors and Collaborators
Pink Pearls Inc
Montméd
Investigators
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Principal Investigator: Lori Berard Pink Pearls Inc
  Study Documents (Full-Text)

Documents provided by Lori Berard, Pink Pearls Inc:

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Responsible Party: Lori Berard, Nurse Consultant, Pink Pearls Inc
ClinicalTrials.gov Identifier: NCT03914183     History of Changes
Other Study ID Numbers: mCPN
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs