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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04859205
Other study ID # 2021-1107
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2021
Est. completion date September 30, 2022

Study information

Verified date April 2021
Source McGill University
Contact Amelie roy-fleming, M.Sc.
Phone 5149875696
Email amelie.roy-fleming@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Health care professionals (HCPs) help an support patients living with type 1 diabetes (PWT1D) who need to achieve optimal blood glucose control in order to prevent short and long term complications of T1D. However, studies show that not all HCPs are aware of T1D management as most of them only see PWT1D occasionally. This makes it difficult for HCPs to remain aware of the particularities of the condition and stay up-to-date on rapidly evolving technologies and therapies available. Moreover, low confidence levels and the inaccessibility to continuing medical education on the specificities of new therapies and technologies might increase the failure of HCPs to propose the optimal treatment plan to their PWT1D. The SUPPORT online platform, that was first developed for PWT1D, was adjusted to suit the needs of HCPs (SUPPORT-Pro). The regularly updated bilingual (English and French) peer-reviewed content of SUPPORT, which covers the various elements that an individual with T1D needs to know to manage the disease and aims at making a better use of technologies and new therapies, is the first in its kind and is highly relevant for HCPs. The main objective of this study is to determine if the SUPPORT-Pro online training platform can increase HCPs' (dietitians, nurses, pharmacists, medical doctors) confidence level in treating individuals with T1D. This study is a non-randomized pre-post trial. We hypothesize that the training provided through the SUPPORT-Pro online platform will significantly increase HCPs' confidence level in treating individuals with T1D after 3 months when compared to their confidence level before the intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Certified Health Care Professional (nurse, physician (including resident in medicine), dietitian, pharmacist) who is member of a regulatory body in Canada 2. Self-reported working with at least 1 patient with type 1 diabetes in the last six months 3. Has access to the Internet 4. Use of an active email address 5. Comprehension of English or French Exclusion Criteria: 1. Certified diabetes educators 2. Working in a T1D specialized clinic 3. Living with T1D 4. Currently living with someone with T1D (e.g. kid, partner, etc.) 5. Working in the pharmaceutical industry

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention
Participants will have access to the SUPPORT-Pro self-guided online training platform addressing many aspects of type 1 diabetes care. The SUPPORT-Pro content was developped by a team of health professionals specialized in type 1 diabetes as well as patient partners. It's content is regularly updated, evidence-based and divided into 6 categories (medication, blood glucose monitoring, diet, physical activity, hypo and hyperglycemia, health and other particularities). In each category, users can pick between 3 levels (beginner, intermediate and advanced) according to their level of confidence and knowledge. Participants will be asked to fill out questionnaires at baseline, 3-month, and 12-month of the intervention which include the following: Eligibility assessment, identification, background, confidence, platform satisfaction.

Locations

Country Name City State
Canada Institut de Recherches Cliniques de Montréal Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the level of confidence in treating individuals with type 1 diabetes measured at 3 months to the level of confidence measured at baseline. Levels of confidence will be measured using a questionnaire inspired from the Maternal Self-Efficacy for Diabetes Management Scale (MSED). For this study, MSED was modified to better assess the self-confidence of health care professionals. We have converted the 17-item questionnaire to a 19-item questionnaire (removing questions specific to familial support and adding questions on new therapies and technologies) and edited the wording of the questions. Every item is rated on a scale from 1 to 5. The satisfaction score will be the sum of all items, on a maximum of 95.
Confidence levels at 3 months and at baseline will be compared using paired t-test with a 95% confidence interval, if normality assumption of the paired difference holds. Otherwise, the non-parametric counterpart, Wilcoxon signed-rank test, will be used and a 95% non-parametric confidence interval will be provided.
3 months
Secondary To compare, in each specific group of HCPs (nurses, dietitians, doctors and pharmacists), the confidence levels in treating their patients with T1D after 3 months of access to the SUPPORT-Pro platform with confidence at baseline. Levels of confidence will be measured using a questionnaire inspired from the Maternal Self-Efficacy for Diabetes Management Scale (MSED). For this study, MSED was modified to better assess the self-confidence of health care professionals. We have converted the 17-item questionnaire to a 19-item questionnaire (removing questions specific to familial support and adding questions on new therapies and technologies) and edited the wording of the questions. Every item is rated on a scale from 1 to 5. The satisfaction score will be the sum of all items, on a maximum of 95.
Confidence levels at 3 months and at baseline will be compared using paired t-test with a 95% confidence interval, if normality assumption of the paired difference holds. Otherwise, the non-parametric counterpart, Wilcoxon signed-rank test, will be used and a 95% non-parametric confidence interval will be provided.
3 months
Secondary To measure the sustainability of change in all HCPs' confidence in treating patients with T1D at 12 months Levels of confidence will be measured at baseline, after 3 months and after 12 months using a questionnaire inspired from the Maternal Self-Efficacy for Diabetes Management Scale (MSED). For this study, MSED was modified to better assess the self-confidence of health care professionals. We have converted the 17-item questionnaire to a 19-item questionnaire (removing questions specific to familial support and adding questions on new therapies and technologies) and edited the wording of the questions. Every item is rated on a scale from 1 to 5. The satisfaction score will be the sum of all items, on a maximum of 95.
Sustainability of change will be assessed by comparing level of confidence at the 3 time points using a one-way repeated measures ANCOVA, with change from baseline as the outcome, and baseline level of confidence adjusted for in the model.
12 months
Secondary Time spent on the platform Using back-end data collected from Google Analytics, the total time (in minutes) spent on the platform during 3 months will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on its normality. 3 months
Secondary Number of posts of the discussion forum Using back-end data collected from Google Analytics, the number of posts on the discussion forum forum will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on its normality. 3 months
Secondary Number of completed courses Using back-end data collected from Google Analytics, the number of completed courses will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on its normality. 3 months
Secondary Number of completed categories Using back-end data collected from Google Analytics, the number completed category (maximum of 6) will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on its normality. 3 months
Secondary Number of viewed videos Using back-end data collected from Google Analytics, the number of viewed videos will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on its normality. 3 months
Secondary Satisfaction of the platform. After using the platform for 3 months, participants will be invited to complete a satisfaction questionnaire which includes open ended questions and a 7-items Likert scale (from 1 to 7, total score on 49).
Continuous endpoints will be presented using mean and SD (standard errors) or median and interquartile intervals, depending on their normality. Categorical variables will be presented using frequencies and percentages.
3 months
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