Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Montméd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Standard of care arm - using insulin pen needles as previously prescribed |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation | 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) | Study duration. 30 to 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lori Berard | Pink Pearls Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoppers Drug Mart 2335 | Calgary | Alberta | T2X3X7 | Canada | ||
| Claresholm Pharamcy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 23, 2018 | Apr 10, 2019 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Open label randomized control study of control (current standard of care) versus mCPN intervention
Not provided
Not provided
Not provided
Not provided
|
| Control | Device | Use of standard of care insulin pen needle |
|
| Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling | 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) | Study duration 30 to 90 days |
| increase/change in injection zone size | Assessment of injection rotation from pre to post survey patient reported | 30-45 days |
| percentage of participating patients who change their needles more often (patient reported), | Assessment of needle reuse or lack of reuse from pre to post survey patient reported | 30 - 45 days |
| the percentage of participating patients who decide to continue using mCPN upon study completion | Willingness to continue with intervention needle from post survey - patient reported | 30- 45 days |
| Claresholm |
| Alberta |
| T0L0T0 |
| Canada |
| Rexall 7236 | Edmonton | Alberta | T5Z0H5 | Canada |
| Shoppers Drug Mart 2401 | Okotoks | Alberta | T1S2N3 | Canada |
| Kipp Mallery Pharmacy | Kamloops | British Columbia | V2C0B6 | Canada |
| Our Own Health Centre | Winnipeg | Manitoba | R3B 0T2 | Canada |
| Shoppers Drug Mart 535 | Winnipeg | Manitoba | R3L1Y2 | Canada |
| Kennegecasis Drugs | Rothesay | New Brunswick | Canada |
| Zak's Pharmacy | Milton | Ontario | Canada |
| Niagara Pharmacy | Niagara Falls | Ontario | Canada |
| Northgate Pharmacy | Sarnia | Ontario | N7T5P5 | Canada |
| Murphy's Cornwall Pharmacy | Cornwall | Prince Edward Island | C0A1H0 | Canada |
| Pharmacie Jacques Bourget PJC076 | Laval | Quebec | Canada |
| Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante | Montreal | Quebec | H4E 3J2 | Canada |