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.
Full Title of Study: “Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Health Services Research
- Masking: Single (Participant)
- Study Primary Completion Date: February 29, 2020
- 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.
Arms, Groups and Cohorts
- 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.
- 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.
Clinical Trial Outcome Measures
- Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire
- Time Frame: Immediately following the intervention
- 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.
- Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire
- Time Frame: 3 months after the intervention
- 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.
- Acceptability Questionnaire
- Time Frame: Immediately following the intervention.
- 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.
Participating in This Clinical Trial
- French-speaking health professionals (in practice and in training).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Canadian Institutes of Health Research (CIHR)
- Provider of Information About this Clinical Study
- Overall Official(s)
- France Légaré, MD, PhD, Principal Investigator, CERSSPUL
- Overall Contact(s)
- France Légaré, MD, PhD, +1 (418) 821-9481, firstname.lastname@example.org
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