Integrating Sex and Gender Into CPD for Depression/Diabetes (INCluDED)

Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial

People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada.

In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: CPD Workshop on Depression and Diabetes

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada
      • CERSSPL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• French-speaking health professionals (in practice and in training).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPD Workshop on Depression and Diabetes; Participants in this arm will take part in a clinical CPD activity on depression and diabetes. The activity will include considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.	Behavioral: CPD Workshop on Depression and Diabetes; 2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.
Sham Comparator: CPD Workshop on Depression and Diabetes II; Participants in this arm will take part in a clinical CPD activity on depression and diabetes. The activity will exclude considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.	Behavioral: CPD Workshop on Depression and Diabetes; 2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire	Clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale. CPD=continuing professional development, REACTION=a theoRy-basEd instrument to assess the impACT of continuing professional development activities on professional behavIOr chaNge. A 12-item Likert-type scale (i.e., Strongly disagree = 1, Strongly agree = 7; Never = 1, Always = 7, etc.) evaluates 5 constructs: 1) intention; 2) social influence; 3) beliefs about capabilities; 4) moral norms; and 5) beliefs about consequences. Sociodemographic questions are asked on sex, age (10 age ranges), province, rural/urban/semi-rural practice, and language of consultation. Mean, standard deviation, median and frequencies are calculated to summarize participant characteristics and questionnaire item responses. Construct scores are obtained by calculating the mean score for the items.	Immediately following the intervention
Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire	Evolution of clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale, after a 3-month period.	3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Questionnaire	1) Participants rate acceptability of workshop with the following 9 items: organization, clarity, mastery of subject by trainer, exercises and discussion, presentation of sex and gender data, group interaction, overall quality, organization and quality of discussions and presentations, quality of documents distributed (Poor, Acceptable, Good, Very Good, or Excellent); 2) Participants rate the workshop length (too short, just right, too long); 3) Participants rate their confidence in incorporating the notions presented in the workshop in their management of Type 2 Diabetes (with or without depression) (scale of 1-10, 1=very little confidence, 10=very confident) both before and after the workshop; 4) Participants describe what changes they will make in their practice following the workshop; 5) Participants describe what they liked most and 6) least about the workshop; 7) Participants are asked if they thought the presentation was biased (yes/no) and if yes, are asked for details.	Immediately following the intervention.

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Canadian Institutes of Health Research (CIHR); Institut du Savoir Montfort; Chaire Claire-Bonenfant-Femmes, Savoir et Société
• Investigators: Principal Investigator: France Légaré, MD, PhD, CERSSPUL

Publications and helpful links

General Publications

• Deom Tardif A, Gogovor A, Guay-Belanger S, Audet D, Parent N, Gaudreau A, Remy-Lamarche D, Vigneault L, Ngueta G, Bilodeau A, Legare F; mATrICES-F Group. Integration of sex and gender in a continuing professional development course on diabetes and depression: a mixed methods feasibility study. BMJ Open. 2022 Apr 22;12(4):e050890. doi: 10.1136/bmjopen-2021-050890.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): July 23, 2020
• Study Completion (Actual): July 23, 2020

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Knowledge translation; Continuing medical education; Sex and gender; Diabetes and depression; Continuing professional development; Minority languages
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 384530

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate anonymous data only in the form of published results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No